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U.S. Department of Health and Human Services

Enforcement Report - Week of September 10, 2014

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Devices Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa Part# CP751506 The Total Temporomandibular Joint (TMJ) replacement system is implanted in the jaw to functionally reconstruct a diseased and/or damaged temporomandibular joint. The Total TMJ replacement system is a two-component system comprised of mandibular condyle and a glenoid fossa components. Both components are available in multiple stock sizes as right and left specific designs and are attached to the bones by screws. Part #CP751506 Lot #478490 Class II Product mix occurred prior to final package and labeling process. Biomet Microfixation, LLC
Biologics Red Blood Cells Leukocytes Reduced W128713068798 Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. Delta Blood Bank
Devices Customed Angiodrape Pack convenience pack include multiple components: syringe 10cc and 30cc, gauze, denture cup, specimen container, band bag, glove, gown, needle hypodermic, absorbent towels, table cover, scalpel,cloth huck towel,iodine povidone,applicator sponge,towel clamp, femoral angiography drape,needle 18G,& Guidewire EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Product code 900-002, 26 lots: 112020289 112030605 112041383 112051709 112061653 112062296 112072757 112093974 112104120 112124901 113015421 113015629 113026199 113036745 113057404 113057683 113068134 113078451 113078655 113099260 131110394 131110574 140211618 140211908 140513048 140613547 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Customed O.B. Pack convenience pack include multiple components: set up cover, absorbent towel, ear ulcer syringe, pad, umbilical cord clamp, wash basin, baby blankets, table cover, gauze sponge, syringe 10CC w/o needle & 10CC with needle, feeding tube, drape, legging with cuff, underbuttock drape, gown, container with lid, mayo tray, receiving blanket, & baby beannies. EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Product code 900-012, 24 lots: 113036306 113015685 112030796 112041172 112062299 112083042 112051659 112093835 113046992 113047150 113015422 113057828 112124902 131110142 113089148 113099380 113078658 131210664 140111130 140211621 140311909 140412444 140513051 140613549 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Customed Laparoscopy convenience pack include multiple components: gowns, table covers, needle and blade counter, bag suture, suture, sponges/gauzes, containers, syringes 20cc & 30cc w/o needle, needle, drape, tubing, towel, dressing island, and blade surgical SS. EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Product code 900-028, 30 lots: 111071871 112041386 112041433 112051660 112051712 112062301 112062560 112093834 112124408 112124903 112125312 113015686 113026162 113036772 113047331 113057830 113068022 113068136 113078564 113089015 113089177 113099559 131110062 131110395 131110575 140111089 140111447 140211739 140312327 140513052 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Customed Major Laparotomy Pack , convenience pack include multiple components: Mayo stand cover, absorbent towel, bag suture, drape, suction tube, lite glove, gauze/sponges, drape, surgical blades, utility bowls, towels, tube suction, cautery tip, gown, and labels. EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Product code 900-036, 34 lots: 111113166 111123284 112010009 112010241 112020297 112030608 112041067 112051663 112062306 112062580 112072761 112093837 112114906 113015423 113025923 113026201 113036746 113057376 113057765 113068023 113068137 113078565 113089178 113099560 131110082 131110396 131110576 131210954 140111448 140211910 140312429 140412881 140513056 140513343 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Customed Cysto Tur Pack, convenience pack include multiple components: legging with cuff, drape cystoscopy, towel absorbent & table cover. EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Product code 900-080, 37 lots: 109061259 109071681 109091967 109102245 109122679 110020427 110040863 110061419 110081951 111030731 111040866 111061577 111071877 111082180 111092575 111102818 111123295 111123409 111123475 112010012 112020300 112072820 112083049 112093839 112124910 113057408 113078229 113088827 113099264 131110145 131210670 140111082 140211626 140311911 140412449 140513057 140613558 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Customed Laparotomy Pack , convenience pack include multiple components: drape laparot., gown, absorbent towel, scrub, stck sponges/ gauzes, table cover, drape sheet, suture bag, duraprep surgical solution, cloth huck towels, utility bowls, suction tube, scalpel, Mayo Tray, Mayo Cover, & lite gloves. EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Product code 900-149, 32 lots: 111113165 111123349 112010052 112010280 112030621 112041077 112051768 112062421 112083062 112093900 112104147 112114637 112114952 113015429 113025941 113026204 113036749 113047333 113057861 113078258 113078600 113089192 113109733 131110083 131110399 131110578 131210961 140111409 140211872 140312328 140412830 140513345 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Customed Femoral Pack , convenience pack include multiple components: Syringe 3cc, 5cc, 10cc, 20cc; swabstick chlorascrub, needles, gauze/sponges, table cover, absrobent towels, halsted Mosquito CVD, gown, bowls, wrapper, scalpel safety, Mosquito forcep, cloth huck, clamp towel, fluorocover, medicine cup, femoral angiodrape, mayo tray, counter & labels. EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Product code 900-164, 14 lots: 110061393 113046935 113047213 113047335 113057700 113068153 113109743 131110191 131110600 140111164 140211648 140311924 140513392 140513453 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Customed LABOR & DELIVERY PACK - Includes: (1) TABLE COVER 44" x 90" (2) LEGGINS WITH/7" CUFF 30" x 42" (5) ABSORBENT TOWELS 15" x 20" LIF (1) BABY BLANKET PRINTED LIF (2) PAD OBSTETRICAL XLGE LIF (1) EAR ULCER SYRINGE 2oz. LIF (1) BABY BLANKET POLY ABS. IMP. LIF (1) Pr. SURGICAL GLOVE # 7Y2 (1) UNDER BUTTOCK DRAPE WITH POUCH (1) BEANNIES BABY LIF (1) FEEDING TUBE 8 Fr. 15" LONG LIF (1) ABDOMINAL DRAPE WITH TAPE L/F (1) DRAPE SHEET 41 " X 58" SMS (1) GOWN SURG. REINFORCED X-LARGE SMS LEVEL IV (1) VAGINAL SPONGE XRD (1) UMBILICAL CORD CLAMP LIF (2) CLOTH HUCK TOWELS BLUE (1 0) GAUZE SPONGE 4" X 4"16 PLY XRD LIF (1) SYRINGE 1 Occ WITH NEEDLE 21 X 1 Y2 (1) MUCUSTRAP 20cc 1 OFr. (1) BOWL PLASTIC 80oz WITH LID (1) WRAPPER 24" X 24" LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Product code 900-168, 34 lots: 110061523 110092042 110092166 110092388 110112612 110123053 111010060 111020331 111041058 111051332 111061506 111071775 111082059 111102842 111113023 111123371 112072440 112083401 112114642 112125025 113026049 113036454 113036752 113057838 113078270 113088750 113089158 113109744 131110336 140111166 140211649 140211925 140513102 140513461 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Universal Pack- - (1) TABLE COVER REINFORCED 50" X 90" LIF (3) TOWEL ABSORBENT 15" X 20" LIF (1) MAYO STAND COVER REINFORCED LIF (1) TUBE SUCTION CONNECT. X" X 12' LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) BAG SUTURE FLORAL (1) DRAPE TOP WITH ADHESIVE 100" X 53" LIF (1) DRAPE BOTTOM ASS REINFORCED 71" X 71" WITH TAPE LIF (1) CAUTERY TIP POLISHER LIF (3) SURGICAL BLADE #1 0 CARBON STEEL (15) LAP SPONGE PREWASH XRD LIF (1) BAG GLASSINE (2) DRAPE SIDE WITH ADHESIVE 36" X 77" (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR L/F (1) LITES GLOVE LIF (3) SURGICAL BLADE #15 CARBON STEEL (1) SPECIMEN CONTAINER 4oz WITH LID & LABEL (1) WRAPPER 24" X 24" (3) GOWN SURG SMS POLY-REINF. BREATHABLE IMP XLGE AAMI IV EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Product code 900-169, 8 lots: 111010061 111040963 111071906 112041402 112051862 113036593 113046891 113088753 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices OPEN HEART TRAY - PACK- (25) SPONGE LAP PREWASH 18" X 18" XRD L/F (1) TRAY PLATO LARGE (3) DRESSING NON ADH TELFA 8 X 3 (2) BAG GLASSINE PLAIN (2) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) COVER TABLE REINFORCED 50" X 90" LIF (1) NEEDLE HYPODERMIC 27G X 'h" (4) COUNTER NEEDLE & BLADE 10c MAG/CLEAR (2) SYRINGE 20cc WITHOUT NDL LUER LOCK LIF (1) JAR 16oz 500cc GRADUATE MEASURE (2) SYRINGE 30cc WITHOUT NDL LUER LOCK L/F (2) PENCIL CAUTERY HAND SWITCHING LIF (1) MARKER SKIN RULER (2) BANDAGE ELASTIC 4" X 5yds LIF (2) POLISHER CAUTERY TIP LIF (2) BANDAGE ELASTIC 6" X 5yds LIF (2) SYRINGE BULB 60cc CLEAR (2) TUBE SUCTION CONNECT Y-t'' X 12' LIF (1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF (1) NEEDLE BLADE/KNIFE 3.0mm (2) CONTAINER SPECIMEN 40z. WITH LID & LABEL (1) BLADE SHARP ALL ARROUND (1) BASIN EMESIS 10 IN 700cc (3) CATHETER 20FR ROB NEL RED RUB (3) BOWL UTILITY QUART 32oz LIF (2) CATHETER THORACIC 32FR STRAIGH (1) LABELS SET, HEPARINE, SALINE, ETC. (2) SAFETY SCALPEL #10 DISP (3) BASIN WASH ROUND 6QT (2) SAFETY SCALPEL #15 DISP (2) BOWL UTILITY 16oz L/F (1) WRAPPER 54" X 54" L/F (1) CONNECTOR Y 3/8" X 3/8" X 3/8" EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Product code 900-170, 45 lots: 110102563 110112615 110123042 111010248 111020273 111041096 111051368 111061709 111071957 111082061 111082257 111092361 111092454 111102694 112010081 112020399 112030637 112041196 112051864 112062443 112072782 112093724 112125027 113015544 113025946 113026104 113036753 113047198 113057812 113068156 113078518 113088755 113089018 113089196 113099566 131110068 131110400 131110579 131210963 140111411 140211740 140312329 140412793 140513106 140513245 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices LAPAROTOMY PACK - CUSTOMED- (1) BAG SUTURE FLORAL (2) TOWEL ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) DRAPE T LAPAROTOMY STD SMS (2) SHEET DRAPE 42" X 57" (1) TABLE COVER REINFORCED 50" X 90" (4) DRAPE UTILITY WITH TAPE EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Product code 900-176, 48 lots: 110030643 110040905 110081992 111020467 111020499 111030609 111030830 111030932 111051336 111051472 111061512 111071910 111072024 111082068 111092366 111092455 111102645 111112937 111113036 111113163 111123386 111123476 112010091 112010247 112010272 112010285 112020410 112020565 112020570 112030693 112030890 112031006 112041370 112051553 112051879 112062449 112062566 112083377 113099568 131110070 131110404 131110581 131210965 140111413 140211741 140312333 140412794 140513112 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices ANGIOGRAPHY PACK- - (4) CLOTH HUCK TOWEL BLUE UF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK UF (2) MEDICINE CUP 2oz. LIF (3) UTILITY BOWL 32oz UF (1) EMESIS BASIN 10 IN 700cc (4) TOWEL CLAMP (3) ABSORBENT TOWELS 15" X 20" LIF (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK L/F (1) HALSTED MOSQUITO (1) PVP SCRUB 8" STICK SPONGE (1) TRAY PLATFORM LARGE (3) LABELS FOR SKIN MARKERR (1) LABEL FOR MEDICATION SALINE NORMAL BLUE (1) LABEL FOR MEDICATION TRIDIL VIOLETA (1) NEEDLE HYPODERMIC 18G X 1 'h (4) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK LIF (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK LIF (2) UTILITY BOWL 16oz (3) BAND BAG WITH RUBBAND & TAPE LIF (25) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF (1) DRAPE ANGlO 75" X 145" (1) NEEDLE HYPODERMIC 21 G X 1 'h LIF (1) SAFETY SCALPEL #11 LIF (1) GOWN STANDARD SMS LARGE VELCRO NECK (2) NEEDLE HYPODERMIC 23G X 1" (1) TRAY ORGANIZER FULL DEEP (1) GOWN LARGE NON REINFORCED SMS TOWEL & WRAP (1) LABEL XYLOCAINE FOR MEDICATION YELLOW (1) LABEL CONTRASTE FOR MEDICATION GREEN (1) LABEL FOR MEDICATION INTEGRILIN RED (1) PVP PAINT 8" STICK SPONGE EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Product code 900-210, 30 lots: 112030717 112041290 112041446 112051934 112072622 112093725 112114388 112114598 113015442 113015630 113036436 113036760 113047216 113057458 113057699 113057816 113068045 113068165 113078572 113089023 113099285 113109786 131110235 131110605 131210967 140111414 140211876 140312332 140412833 140513348 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices 0.B. PACK - HSCH- (1) PVP SCRUB 8" STICK SPONGES (1) UNDERBUTTOCK DRAPE WITH POUCH (2) LEGGINS WITH 7" CUFF 30" X 42" (1) ABDOMINAL DRAPE WITH TAPE LIF (1) SPONGE LAP PREWASH 18" X 18" XRD LIF (1) BOWL PLASTIC WITH LID 80oz LIF (1) RECEIVING BLANKET 100% COTTON (1) BABY BLANKET IMPERVIOUS POLY ABS. LIF (1) UMBILICAL CORD CLAMP (3) ABSORBENT TOWELS 15" X 20" LIF (1) UTILITY BOWL 16oz LIF (2) TRAY ORGANIZER FULL DEEP (3) ABSORBENT TIP APPLICATOR (2) GLOVE EXAM MEDIUM (1) GOWN SURGICAL REINFORCED LARGE TOWEL/WRAP (10) GAUZE SPONGE 4" X 4" 12PLY (2) PAD OBSTETRICAL X-LARGE ST. LIF (1) EAR ULCER SYRINGE 2oz UF (1) BABY BEANNIES (2) DRAPE SHEET 41 " X 58" SMS (1) SCISSORS UMBILICAL (1) TABLE COVER REINFORCED 44" X 78" L/F (2) WRAPPER 24" X 24" LI EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Product code 900-254, 22 lots: 111113093 111123230 112030815 112041318 112051972 112093935 112114665 113026059 113026113 113036348 113036461 113047019 113047218 113057472 113088799 113089161 113109797 131110249 131210793 140312134 140412465 140412904 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices LAPAROTOMY PACK - (I) SURGICAL BLADE #10 S/STEEL ( I) UTILITY BOWL 32oz (I) UTILITY BOWL 16oz (2) NEEDLE & BLADE COUNTER IOC MAG/CLEAR ( I) DRAPE T LAPAROTOMY STD SMS (2) TOWELS ABSORBENT 15" x 20" (2) GOWN IMP. REINFORCED LARGE SMS (4) DRAPE UTILITY WITH TAPE ( I) TABLE COVER REINFORCED 50" X 90" ( I) MAYO STAND COVER REINFORCED ( I) ELECTRODE DUAL DEPRES./GROUNDPAD ( I ) CAUTERY PENCIL ROCKER SWITCH (2) DRAPE SHEET 42" X 55" SMS EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Product code 900-281, 20 lots: 111061489 112093652 112104098 112114587 112125082 113015512 113015694 113036462 113036731 113057616 113057845 113068168 113078603 113089070 113109824 131110075 131110408 131110585 131210969 140111451 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices LAPAROTOMY PACK - (I) UTILITY BOWL 16oz ( I) ELECTRODE DUAL DEPRES./GROUNDPAD (I) UTILITY BOWL 32oz ( I) GOWN IMP. REINFORCED XL SMS AAMI Ill (2) NEEDLE & BLADE COUNTER I OC MAG/CLEAR ( I) DRAPE LAPAROT ABDOM WITH POUCH (2) TOWELS ABSORBENT 15" x 20" ( I) TIME OUT BEACON NON WOVEN (4) DRAPE UTILITY (I) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER (I) MAYO STAND COVER REINFORCED ( I) SUTURE BAG FLORAL (I) TABLE COVER REINFORCED 50" X 90" ( I) GOWN IMP EXTRA REINF LGE TOWEUWRAP (2) DRAPE SHEET 42" X 55" SMS (I) CAUTERY TIP POLISHER (I) CAUTERY PENCIL ROCKER SWITCH ( I) BAG GLASSINE (I) SURGICAL BLADE# 10 STAINLESS STEEL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Product code 900-281A, 3 lots: 140312027 140412669 140412796 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices BASIC PACK W/OUT GOWN- (1) TABLE COVER REINFORCED 50" X 90" UF (4) DRAPE UTILITY WITH TAPE UF (1) TOWEL ABSORBENT 15" x 20" L/F (1) SUTURE BAG FLORAL (1) DRAPE SHEET 42" X 57" SMS g~ SHEET o/. 57" X 63" REINFORCED SMS UF MAYO STAND COVER REINFORCED UF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Product code 900-345, 38 lots: 109122917 110020470 110030770 110040936 110071690 110092240 110112640 111010116 111030655 111051294 111051326 111071845 111082215 111092537 111102740 111113101 111123239 112010162 112030866 112051977 112093937 112104306 112124703 112124858 113025959 113036353 113046956 113067922 113088810 113089162 113109830 131210950 140211466 140312155 140412559 140513144 140513338 140613746 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices OPHTALMIC PACK- (3) ABSORBENT TOWELS 15" X 20" LIF (1) MAYO STAND COVER REINFORCED LIF (1) OPHTALMIC DRAPE WITH POUCH LIF (2) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF (10) COTTON TIP APPLICATOR 6" WOOD (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (2) NEEDLE HYPODERMIC 18G X 1 Y." (1) NEEDLE HYPODERMIC 25G X 5/8" (2) EYE PAD 2 1/8 X 2 5/8 UF (5) EYE SPEAR MICRO SPONGE (2) LITE GLOVE LIF (1) CABLE BIPOLAR (1) EYE SHIELD UNIVERSAL (1) OPHTALMIC PENCIL BIPOLAR (1) IV ADM. SET 15 DROPS 106" LONG L/F (1) TABLE COVER REINFORCED 50" X 90" UF (1) KNIFE/BLADE MIN. EDGE ROUND (1) KNIFE 15 5.0 CONTROLLED (1) PLASTIC TRAY 3/COMPARTMENT (1)KNIFE 3.2MM ANGLE BEVEL UP (1) CYSTOTOMO IRRIG. 25GA X5/8 (1) MAYO TRAY LARGE (2) GOWN STANDARD LARGE SMS STD VELCRO NECK (1) PVP PAINT 8" STICK SPONGE (1) NEEDLE & BLADE COUNTER 30c MAG/MAG/LF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Product code 900-357, 2 lots: 113099550 113109831 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices ANGIODRAPE PACK - - (1) GUIDEWIRE 0.035" X 150cm (2) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK UF (2) Pr. SURGICAL GLOVES #8 (2) GOWN STANDARD LARGE SMS VELCRO NECK (2) NEEDLE HYPODERMIC 21G X 1 W' UF (1) TABLE COVER 44" X 90" (3) CLOTH HUCK TOWELS BLUE (2) UTILITY BOWL 16oz L/F (1) SOLUTION SURGICAL DURAPREP 26ML UF (3) DRAPE UTILITY WITH TAPE UF (3) TOWEL CLAMP (2) TOWELS ABSORBENT 15" X 20" UF (1) NEEDLE 18G X 2% AMC/4 (1) FEMORAL ANGlO DRAPE WITH POUCH UF (1) BAND BAG RUBBAND & TAPE UF (1) CUP DENTURE WITH LID (30) GAUZE SPONGE 4" X 4" 12PL Y (2) TIP ASBORBENT APPLICATOR STICK SPONGE (1) SCALPEL WITH HANDLE #11 (1) STOPCOCK 3 WAY (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK L/F (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Product code 900-366, 5 lots: 113026100 113057477 113078475 113088811 113109832 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices CESAREAN PACK - - (7) TOWELS ABSORBENT 15" X 20" (2) SCALPEL WEIGHTED SAFETY #1 0 (1) BLANKET BABY 30" X 30" POLY ABS IMP (1) BOWL UTILITY QUART 32oz. (1) TUBE FEEDING 8Fr. 15" LONG (2) COUNTER NEEDLE/BLADE 10C MAG/CLEAR (1) BEANNIES BABY (2) PAD OBSTRETICAL XLGE ST. (1) SYRINGE 20cc W/0 NEEDLE LIL (1) SYRINGE EAR/ULCER 2oz. (1) BLANKET RECEIVING 100% COTION (1) CLAMP UMBILICAL CORD ST. (1) COVER TABLE REINFORCED 50" X 90" (1) SYRINGE 10CC W/0 NEEDLE L/LOCK (1) BOWL PLASTIC W/LID 80oz (2) GOWN XL SMS IMPERVIOUS REINFORCED (1) SHEET DRAPE 41" X 58" SMS (1) DRAPE C SECTION W/POUCH 102" X 121" X 78" (1) YANKAUER SUCTION TUBE W/0 VENT (1) WRAPPER 30" X 30" (15) SPONGE LAP PREWASH 18" X 18" XRD (1) TIME OUT BEACON NON WOVEN ST. (1) TUBE SUCTION CO NN ECT~" X 12' (2) LIGHT SHIELD (1) GOWN SURG REINF LARGE T/WRAP (2) PK. STRIP STERI CLOSURE W' X 4" (1) POLISHER CAUTERY TIP (1) DRESSING COMP OP 4" X 14" (1) COVER MAYO STAND REINFORCED (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Product code 900-403, 30 lots: 112020525 112030955 112031372 112051682 112062486 112093590 112104107 112125170 112125315 113015449 113015695 113025960 113036485 113046957 113057479 113057817 113068169 113078573 113088813 113099289 113099571 131110076 131110409 131110586 131210970 140211667 140311937 140312382 140412836 140513246 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices MAJOR LAP PACK - (1) TABLE COVER REINF. 50" X 90" 10) GUZE SPONGE 4" X 4" 16PLY XRD (1) DRAPE T LAPAROT 102" X 78" X 121" SMS (1) UTILITY BOWL 32oz (1) TUBE CONNECT. SUCTION W X 12' (1) CAUTERY TIP POLISHER (1) YANKAUER SUCTION TUBE W/0 VENT (4) DRAPE UTILITY WITH TAPE (2) LIGHT SHIELD (1) MAYO STAND COVER REINFORCED (4) ABSORBENT TOWELS 15" X 20" (2) DRAPE SHEET 41" X 58" SMS (2) NEEDLE & BLADE COUNTER 1 Oc MAG/CLEAR (2) GOWN XL SMS IMPERV. REINFORCED (1) SUTURE BAG FLORAL (1) TIME OUT BEACON NON WOVEN (5) LAP SPONGE PREWASH 18" X 18" XRD (1) SKIN MARKER W/8/LABEL/TIME OUT/RULER EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Product code 900-404, 35 lots: 102030840 111030924 111041044 111051296 111061668 111123243 112010164 112020524 112041317 112041373 112041448 112062487 112083429 112114599 112125087 112125314 113025961 113036355 113036763 113047220 113057480 113057846 113068046 113078323 113078574 113089071 113099290 113099572 131110410 131110587 131210971 140111452 140211742 140412837 140513247 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices CESAREAN PACK - - (1) MAYO STAND COVER REINFORCED LIF (20) LAP SPONGES PRE-WASH XRD LIF (1) UMBILICAL CORD CLAMP LIF (1) COVER TABLE REINFORCED 50" X 90" LIF (1) SURGICAL DURAPREP SOLUTION 26ML LIF (1) BEANNIES BABY (1) POLISHER TIP CAUTERY LIF (1) LITE GLOVE L/F (1) CAUTERY PENCIL ROCKER SWITCH L/F (1) C-SECTION DRAPE WITH POUCH LIF (1) MAYO TRAY SMALL (1) YANKAUER SUCTION TUBE WITHOUT VENT L/F (1) BLADE SURGICAL #10 CARBON STEEL (2) BOWL UTILITY 32oz. LIF (2) PAD OBSTETRICAL X- LARGE LIF (5) TOWEL ABSORBENT 15" X 20" LIF (1) DRAPE SHEET 41" X 58" SMS LIF (1) TUBE SUCTION CONNECT. Y.." X 12' LIF (1) EAR ULCER SYRINGE 2oz. LIF (2) GOWM IMPERVIOUS EXTRA REINFORCED X-LARGE (1) RECEIVING BLANKET 100% COTTON (2) NEEDLE & BLADE COUNTER 1 Oc MAG/CLEAR LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Product code 900-410, 24 lots: 112020166 112020534 112030841 112041322 112051983 112062488 112072871 112083430 112093939 112114673 112125090 113025992 113036358 113036764 113078476 113078814 113099291 113099573 131110300 140111223 140211668 140312159 140412838 140513349 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices LAPAROSCOPY CHOLE PACK - - ( 1) STRIP STERI CLOSURE W' X 4" LIF ( 1) TABLE COVER REINFORCED 50" X 90" LIF ( 1) DRAPE LAP ABDOMINAL W/POUCH 102" X 122" X 78" LIF (2) GOWN LGE SMS IMPERVIOUS REINFORCED LIF ( 1) GOWN XL SMS IMPERVIOUS REINFORCED L/F (5) TOWELS ABSORBENT 15" X 20" LIF (5) LAP SPONGE PREWASH 18" X 18" XRD LIF (4) DRAPE UTILITY WIT APE LIF ( 1) COVER CAMERA W/ELAST LIF (2) GAUZE SPONGE 4" X 4" 12PL Y LIF ( 1) NEEDLE ULTRA VERES 120mm LIF (2) DRAPE SHEET 41 " X 58" SMS LIF ( 1) SCALPEL WEIGHTED SAFETY #11 ( 1) TUBING INSUFFLATING OPEN TIP W/0 VENT LIF ( 1) DRESSING TEGADERM 4" X 4 %" LIF ( 1) TUBE SUCTION CONNECT X" X 12' LIF ( 1) MAYO STAND COVER REINFORCED LIF ( 1) SUTURE BAG FLORAL LIF ( 1) Pk. STERI STRIP LAP SET LATEX ( 1) CORD LAPAROSCOPY MONOPOLAR LIF ( 1) MAYO TRAY SMALL LIF ( 1) TIME OUT BEACON NON WOVEN ST. LIF (1) SKIN MARKER INK W/8 LABEL TIME OUT/RULER LIF ( 1) BAG ZIP LOCK PLASTIC 6" X 10" EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Product code 900-414, 26 lots: 112030868 112041328 112051656 112062284 112072802 112093940 112104108 112114600 113015696 113025963 113036361 113036800 113057485 113068047 113068170 113088863 113089072 113099574 131110261 131210813 140111100 140211669 140311938 140412466 140412887 140513363 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices LABOR & DELIVERY PAC - 1) NEEDLE HYPODERMIC 18G X 1% ST. (2) DRAPE UNDERBUTTOCK WITH POUCH (4) TOWELS ABSORBENT 15" X 20" ( 1) FEEDING TUBE 8FR, 15" LONG ( 1) BEANNIES BABY ( 1) SYRINGE 20cc WITHOUT NEEDLE LILOCK ( 1) UMBILICAL CORD CLAMP ST. ( 1) RECEIVING BLANKET 100% COTTON ( 1) TOWELS CLOTH HUCK (BLUE) (2) LEGGINGS W/7" CUFF 30" X 42" ( 1) BABY BLANKET 30 X 30 POLY ABS IMPERV. ( 1) BOWL PLASTIC 80oz ( 1) LID FOR BOWL 80oz CLEAR (20) GAUZE SPONGE 4" X 4" 16PLY (2) PAD OBSTETRICAL X-LARGE ST. ( 1) PACKING VAGINAL XRD 4 X 36 8PLY ( 1) TABLE COVER REINFORCED 50" X 90" ( 1) DRAPE ABDOMINAL WITH TAPE 40" X 54" (1 ) NEEDLE HYPODERMIC 21G X 1% ST. (2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK (2) PVP SCRUB 8" STICK SPONGES ST. ( 1) EAR ULCER SYRINGE 2oz. ( 1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED (2) WRAPPER 30" X 30" ( 1) PVP PAINT 8" STICK SPONGE ST. (2) GLOVE SURG DERMA PRENE #7 % PF (1) TIME OUT BEACON NON WOVEN ST. (1) VACUTAINER GREEN NAHEP 10ML EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Product code 900-419, 16 lots: 112041449 112093941 112114601 113025847 113026169 113036364 113047313 113067871 113078327 113089073 113099292 131110077 131210815 140111228 140211670 140311939 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices CYSTO TUR PACK- - (1) UTILITY BOWL 32oz LIF (1) SPECIMEN CUP WITH CAP 4oz LIF (1 0) GAUZE SPONGE 4" X 4" 12PL Y LIF (4) ABSORBENT TOWELS 15" X 20" LIF (1) CYSTOSCOPY 'T' DRAPE 60" X 87" X 35" SMS STD LIF (2) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE LIF (2) LEGGINS WITH 7" CUFF 30" X 42" LIF (1) TABLE COVER REINFORCED 44" X 78" LIF (1) UNDERBUTTOCK DRAPE WITH POUCH 44" X 35" LIF (1) SYRINGE 60ML SLUER SLIP WITHOUT NEEDLE LIF (1) TUR Y SET 81 "2.1 M REGULAR CLAM (4) GAUZE SPONGES 4" X 4" 12 PLY XRD L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Product code 900-430, 29 lots: 110020453 110030667 110051146 111030671 111040897 111061672 111071814 111082217 111092389 111102877 111113116 111123253 112010174 112030874 112041411 112072872 112083431 113015513 113015697 113036365 113047211 113057626 113078328 113088864 113109841 131110304 140111229 140312164 140412467 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices MINOR LAPAROTOMY PACK - (1) DRAPE T LAPAROTOMY (1) BAG SUTURE FLORAL LIF (4) DRAPE UTILITY WITH TAPE LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) MAYO STAND COVER REINFORCED LIF (4) TOWELS ABSORBENT 15" X 20" LIF (2) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE (1) DRAPE% ECONOMY 53" X 77" LIF (1) CAUTERY PENCIL ROCKER SWITCH (1) UTILITY BOWL 16oz (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Product code 900-450, 60 lots: (1) DRAPE LAP ABDOMINAL WITH POUCH (1) CAMARA DRAPE 9" X 96" LIF (5) TOWELS ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) TABLE COVER REINFORCED 50" X 90" (4) DRAPE UTILITY WITH TAPE (3) DRAPE SHEET 41" X 58" SMS (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR (5) LAP SPONGE PREWASH  ...
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Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices LAPAROSCOPY PACK- - (1) DRAPE LAP ABDOMINAL WITH POUCH (1) CAMARA DRAPE 9" X 96" LIF (5) TOWELS ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) TABLE COVER REINFORCED 50" X 90" (4) DRAPE UTILITY WITH TAPE (3) DRAPE SHEET 41" X 58" SMS (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR (5) LAP SPONGE PREWASH 18" X 18" XRD (1) GOWN LGE SMS IMPERVIOUS REINFORCED (2) GOWN X-LARGE SMS IMPERV. REINFORCED (2) MEDICINE CUP 2oz. (1) NEEDLE HYPODERMIC 18G X 1% ST. ( 1) BLADE SURG. # 15 CARBON STEEL (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK (2) NEEDLE & BLADE COUNTER 1 Oc MAG/CLEAR (1) DRESSING TEGADERM 4" X 4%" (1) SOLUTION SURGICAL DURAPREP 6mL (1) TRAY MAYO SMALL (1) TUBE SUCTION CONNECT. %"X 12' (10) GAUZE SPONGE 4" X 4" 16PLY XRD (1) NEEDLE ECLIPSE 22 X 1% (1) TIME OUT BEACON NON WOVEN ST EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Product code 900-474, 19 lots: 112030843 112103944 112114393 112114480 112125096 113015452 113036801 113057847 113078330 113088867 113089075 113109844 131110262 131210818 140111232 140211671 140412469 140412888 140513480 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices LAPAROSCOPY~OBPACK - (4) ABSORBENT TOWELS 15" x 20" LIF (2) LEGGINS WITH 7" CUFF (1) LAPAROSCOPY T SHEET SMS (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) NEEDLE HYPODERMIC 18G X 1% (1) *ROBIN REDRUBBER CATHETER 14FR LATEX (1) DRAPE LASER CAMERA W/EL LIF (1) PAD OBSTETRICAL X-LARGE 6" X 96" LIF (3) TOWEL CLAMP (4) DRAPE UTILITY WITH TAPE LIF (1) GOWN SURGICAL POLY REINFORCED BREATHABLE IMP LARGE LEVEL IV (2) GOWN SURG POLY REINFORCED BREATHABLE IMP XL SMS LEVEL IV (20) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) TABLE COVER 44" X 90" (1) MAYO STAND COVER REINFORCED LIF (1) SURGICAL BLADE #15 CARBON STEEL (1) LITE GLOVE LIF (1) DRESSING NON-ADHESIVE TELFA 4" X 3" (1) TUBE SUCTION CONNECT Y4" X 12' LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Product code 900-484, 25 lots: 110112811 110123129 111010130 111030679 111040976 111051201 111071818 111082100 111092392 111092547 111123258 112020476 112041331 112072873 112083432 112093945 113026060 113026073 113036489 113036802 113067928 113088868 113109845 131210819 140211845 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices LAPAROSCOPY PACK - - (1) MAYO STAND COVER REINFORCED LIF (2) DRAPE % ECONOMY 53" X 77" LIF (1) TUBE SUCTION CONNECT. v.i" X 12' LIF (1) SCALPEL WITH HANDLE #11 (1) DRAPE LAP ABDOMINAL WITH POUCH 1 02" X 122" X 78" LIF (1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF (8) TOWEL ABSORBENT 15" X 20" L/F (1) TABLE COVER REINFORCED 50" X 90" L/F (1) *LAPAROSCOPIC WOUND CLOSURE LATEX (1) DRAPE LASER CAMERA WITH/EL 6" X 96" LIF (4) DRAPE UTILITY WITH TAPE L/F (3) GOWN IMPERVIOUS REINFORCED X-LARGE SMS L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Product code 900-486, 39 lots: 109102328 109112574 109122809 110010090 110020385 110030671 110030811 110051245 110071697 110102446 110112662 111010131 111020373 111030681 111041112 111113120 111123259 111123435 112020536 112030844 112051987 112093629 112114394 112114481 112114571 113015453 113025988 113036367 113057489 113067929 113099436 113109846 131110263 131210820 140111233 140312167 140412470 140412907 140513249 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices LAPAROTOMY BASIC PACK- CUSTOMED- (1) TABLE COVER REINFORCED 44" X 78" LIF (1) COVER MAYO STAND REINFORCED UF (2) TOWEL ABSORBENT 15" X 20" UF (1 0) GAUZE SPONGES XRD 4" X 4"-12PL Y (2) DRAPE SHEET 41 " X 58" SMS UF (4) DRAPE UTILITY WITH TAPE L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Product code 900-547, 19 lots: 109010180 109030602 110020394 110041044 110061584 110071846 110112813 111030690 111102881 112020520 112030884 112051719 112083433 113025793 113036491 113046966 113057746 140111076 140312175 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices PERY GYN PACK - (1) TABLE COVER REINFORCED 44" X 78" UF (2) TOWEL ABSORBENT 15" X 20" LIF (2) GOWN LARGE SMS IMPERVIOUS REINFORCED (1) DRAPE UNDERBUTTOCK WITH POUCH (1) UTILITY BOWL 16oz. (10) GAUZE SPONGE 4" X 4" 16PL Y XRD UF (1) ROBNEL CATHETER 18FR. (1) DRAPE SHEET 41 " X 58" SMS (2) LEGGINS WITH 7" CUFF 30" X 42" (1) DRAPE UTILITY WITH TAPE UF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Product code 900-548, 60 lots: 109010181 109030603 109051042 109061206 109071558 109081861 109092069 109102334 109112579 109122695 110010096 110020395 110030677 110040948 110051248 110051360 110061461 110071847 110082073 110092262 110092399 110112663 110123108 111010139 111020289 111030691 111040905 111051209 111061555 111071826 111082102 111092553 111102766 111123268 112010186 112020489 112030845 112041337 112051995 112062490 112072805 112083434 112093640 112104099 112114678 113015454 113036442 113047025 113047205 113057493 113057747 113068175 113088875 113099441 113109856 131110266 131210828 140111238 140211731 140211940 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices PERY GYN PACK - (1) TABLE COVER REINFORCED 44" X 78" (1) DRAPE UTILITY (2) TOWELS ABSORBENT 15" X 20" (1) GOWN XL SMS IMPERV. REINF. AAMI LEVEL Ill (1) DRAPE UNDERBUTIOCK W/POUCH 44" X 35" (1) TIME OUT BEACON NON WOVEN (1) BOWL UTILITY BLUE 16oz (1) BAG SUTURE FLORAL (1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD (1) GOWN IMPERV. EXTRA REINF LGE AAMI LEVEL Ill T/WRAP (1) CATHETER 16" 18FR MALE PVC (2) LEGGINS W/7'' CUFF 30" X 44" EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Product code 900-548A, 2 lots: 140312022 140412694 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices LAPAROSCOPY CHOLECYSTECTOMY PACK - (1) SHEET LAPAROS/ABDOMINAL UF (1) MAYO STAND COVER REINFORCED UF (1) BLADE SURGICAL #11 STAINLESS STEEL (1) DRAPE SHEET 41 " X 58" SMS UF (10) GAUZE SPONGE 4" X 4" 16PL Y XRD UF (1) TUBE SUCTION CONNEC. 3/16" x 12' UF (3) TOWEL ABSORBENT 15" X 20" UF (1) GOWN IMPER. EXTRA REINFORCED LGE TIWRAP (1) TABLE COVER REINFORCED 50" X 90" UF (2) GOWN LARGE SMS IMPERV. REINFORCED (4) DRAPE UTILITY WITH TAPE UF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Product code 900-576, 26 lots: 109020368 109030605 109040844 109051043 109061293 109071535 109081864 109092110 109102391 112030885 112041338 112051871 112062293 112072806 112114577 112125102 113025987 113036372 113078334 113088940 113099442 113109857 131210829 140111239 140211732 140211941 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices LAPAROSCOPY CHOLECYSTECTOMY SURGICAL PACK - - (1) DRAPE LAPAROS/ABDOMINAL UF (1) GOWN IMPER. EXTRA REINFORCED LGE TIVVRAP (1) BLADE SURGICAL #11 STAINLESS STEEL (1) TIME OUT BEACON NON WOVEN UF (10) GAUZE SPONGE 4" X 4" 16PLY XRD UF (1) GOWN XLARGE SMS IMPERV. REINFORCED (3) TOWEL ABSORBENT 15" X 20" UF (1) TUBBING INSUFFLATION SET WITHOUT RING (1) MAYO STAND COVER REINFORCED UF (1) NEEDLE & BLADE COUNTER 20c FOAM/MAG UF (1) TABLE COVER REINFORCED 50" X 90" UF (1) SKIN MARKER INKW/8LABEUTIME OUT/RULER (1) DRAPE SHEET 41 " X 58" SMS UF (1) BAG SUTURE FLORAL (4) DRAPE UTILITY UF (1) TUR CYSTO IRRIGATION SET 79" SINGLE UF (1) TUBE SUCTION CONNECT. 3/16 " x 12' UF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-576A, 2 lots: 140312024 140513373 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices LAPAROSCOPY GYN PACK - - (1) BLADE SURGICAL #11 STAINLESS STEEL (4) DRAPE UTILITY WITH TAPE LIF (2) ABSORBENT TOWEL 15" X 20" LIF (1) GOWN IMPERVIOUS REINFORCED LARGE SMS (1) TOWEL CLOTH HUCK BLUE (1) BLADE SURGICAL #15 CARBON STEEL (2) UTILITY BOWL 16oz (1) UTILITY BOWL 32oz (2) LEGGINS WITH 7" CUFF 30" X 42" LIF (1) EMESIS BASIN 10in 700cc (1) DRAPE VIDEO CAMERA 13cm X 244cm LIF (1) MAYO STAND COVER REINFORCED LIF (10) GAUZE SPONGES 4" X 4" 16PLY XRD LIF (2) TUBE SUCTION CONNECT 114" X 12' LIF (1) TABLE COVER REINFORCED 44" X 78" UF (1) DRAPE LAP. PERINEAL 102" X 97" WITH POUCH (1) GOWN SURGICAL REINFORCED LARGE TOWEL/WRAP EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-605, 34 lots: 110092266 110102447 110112666 110123109 111010142 111020291 111030694 111040908 111061557 111071939 111082104 111092395 111102768 111113129 111123270 112010189 112020490 112030886 112051997 112062497 112072807 112083435 112093728 112124593 112125104 113078336 113088877 113099445 113109859 131110267 131210832 140111091 140312177 140412696 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices ANGIOGRAPHY PACK - ( 1) FEMORAL ANGlO. DRAPE WITH POUCH (2) SYRINGE 10cc W/0 NEEDLE LUER LOCK LIF (2) NEEDLE HYPODERMIC 21G X 1% ( 1) TABLE COVER REINFORCED 44" X 78" LIF (30) GAUZE SPONGES 4" X 4" 12PLY ( 1) GOWN IMPERVIOUS REINFORCED LARGE SMS ( 1) GOWN LARGE NON REINFORCED SMS TOWEL & WRAP ( 1) GUIDEWIRE .035" X 150cm MOVABLE (2) BAND BAG RUBBAND & TAPE L/F (2) DENTURE CUP 8oz. WITH LID ( 1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF ( 1) NEEDLE HYPODERMIC 18G X 1 % ( 1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK L/F (4) DRAPE UTILITY WITH TAPE L/F (2) SOLUTION SURGICAL DURAREP 6ml L/F (2) TOWEL CLAMP (1) NEEDLE 18G X 2% AMC/4 (4) TOWELS CLOTH HUCK BLUE ( 1) UTILITY BOWL 16oz. LIF ( 1) SCALPEL WITH HANDLE # 11 EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-610, 26 lots: 111123130 111123272 112010190 112030731 112041339 112051998 112062498 112093947 112114578 112125303 113025825 113026192 113036373 113036696 113047161 113057494 113067874 113078337 113089077 113109860 131110268 131210661 140111087 140211673 140311942 140513221 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices LAPAROSCOPY GYN PACK - (1) TABLE COVER REINFORCED 44" X 78" (1) LAPAROSCOPY SHEET "T" SMS (3) TOWELS ABSORBENT 15" X 20" (1) SURGICAL BLADE#11 STAINLESS STEEL (1) MAYO STAND COVER REINFORCED (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK (2) LEGGINS WITH 7" CUFF 30" x 42" (1) UNDERBUTTOCK DRAPE WITH POUCH 44" X 35" (4) DRAPE UTILITY WITH TAPE (2) GOWN IMPERVIOUS REINFORCED LARGE SMS (1) CONNECTING TUBING 3/16" X 12" EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-618, 24 lots: 109010109 109030609 109040846 109051047 109061208 109071536 109071688 109092073 109102337 112020491 112030732 112051999 112062499 112083436 112093647 113036805 113057495 113057617 113078338 113088878 113099446 113109861 140211734 140312178 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices ARTHROSCOPY PACK - (1) MAYO STAND COVER REINFORCED LIF (1 0) GAUZE SPONGES 4" X 4" 16PL Y (1) TUBE SUCTION CONNECTING X" X 12' LIF (1) IMP. STOCKINETTE (1) SURGICAL BLADE #11 STAINLESS STEEL (1) ANESTHESIA SPINAL NEEDLE 18G X 3 ~ (1) SYRINGE Sec WITH NEEDLE 21G X 1 ~ LUER LOCK LIF (2) ELASTIC BANDAGE 6" X 5yrd LIF (1) TUR Y SET 81 "2.1m REGULAR CLAM (2) NEEDLE HYPODERMIC 18G X 1 ~ (1) TABLE COVER 50" X 90" REINFORCED LIF (5) TOWEL ABSORBENT 15" X 20" LIF (2) DRAPE UTILITY WITH TAPE LIF (1) DURAPREP SURGICAL SOLUTION 26m I LIF (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (1) Pr. NEUTRALON SURGEON GLOVES #7.5 (1) Pr. NEUTRALON SURGEON GLOVES #8 (1) Pr. NEUTRALON SURGEON GLOVES #8.5 (2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS (10) GAUZE SPONGES 4" X 4" 16PLY XRD (2) STRIPS TAPE (1) SHEET ARTHROSCOPY T STD SMS WITH POUCH LIF (1) DRAPE VIDEO CAMERA LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-620, 28 lots: 111113132 111123276 112010192 112020517 112030733 112041340 112052000 112062500 112072808 112083437 112093729 112114579 112124875 113015455 113025964 113036374 113036444 113068176 113088879 113099447 113109862 131210833 140111241 140211733 140211943 140412839 140513377 140513456 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices O.R. TOWELS- CUSTOMED- (6) TOWELS CLOTH HUCK BLUE ( I) WRAPPER 20" X 20 EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-629, 26 lots: 109061450 109102339 110030682 110041125 110071851 110123058 111020294 111020444 111040911 111051251 111092555 111113133 112010193 112030734 112072918 112124704 113036701 113046967 113047229 113057748 113088880 131110309 131110345 140312179 140513154 140613796 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices FANFOLD DRAPE - CUSTOMED (1) DRAPE SHEET 42" X 57" SMS (1) WRAPPER 24" X 24" EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-633, 56 lots: 109020284 109040849 109051210 109071550 109092075 109102340 109112583 109122699 110010102 110010242 110020460 110030683 110030781 110041029 110051365 110071704 110082030 110092351 110102554 110102670 110122940 111010146 111020229 111030685 111040913 111051394 111051461 111061682 111061683 111071941 111071967 111082323 111092606 111102772 112041342 112052001 112062213 112062502 112083438 112093948 113036375 113036674 113036735 113047026 113057496 113068177 113078605 113089078 113099293 113109865 131110269 131210834 140211674 140412471 140412797 140513350 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices PERY GYN PACK- (1) DRAPE UTILITY WITH TAPE UF (1) UNDERBUTTOCK DRAPE WITH POUCH (2) ABSORBENT TOWELS 15" x 20" UF (2) LEGGINS W/7'' CUFF 30" X 42" (1) TABLE COVER REINFORCED 50" X 90" UF (1) ABDOMINAL DRAPE WITH TAPE UF (1) UTILITY BOWL 16oz. (1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD UF (1) PAD OBSTETRICAL XL LIF (2) SPECIMEN CONTAINER 4oz. W/LID & LABEL (1 ) SYRINGE 1 Occ PREFILLED W/GEL (1 ) DRAPE SHEET 41 " X 69" MEDIUM UF (1 ) CATHETER 14FR. ROB. NELAT (1) NON-ADHESIVE TELFA DRESSING (2) GOWN IMP. REINFORCED LGE SMS EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-635, 42 lots: 110040968 110051274 110051406 110092404 110112815 110112897 111020476 111030646 111041113 111051299 111061558 111071830 111082247 111092399 111102773 111112950 111123278 112020492 112041343 112083439 112093730 112125105 112125304 113015514 113036673 113036736 113047027 113057609 113067934 113068178 113088881 113099448 113109866 113507497 131110310 131210835 140111242 140211675 140211944 140312385 140412840 140513250 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices 0.B. PACK - - (1) TABLE COVER 44" x 90" (1) UNDERBUTTOCK DRAPE WITH POUCH (2) LEGGINS WITH 7" CUFF 30" x 42" (1) GOWN IMPERVIOUS REINFORCED LARGE SMS (3) TOWELS ABSORBENT 15" x 20" (1) PAD OBSTETRICAL X-LARGE (1) VAGINAL SPONGE XRD (10) GAUZE SPONGES 4" X 4" 12PLY XRD (1) CORD UMBILICAL CLAMP (1) BABY BLANKET PRINTED (2) EAR/ULCER SYRINGE 2oz (1) SET UP COVER CLEAR POLY (1) BASIN WASH 7QT. (1) ABDOMINAL DRAPE WITH TAPE LIF (2) KELLY FORCEP STRAIGHT 5 % (1) MAYO SCISSOR STRAIGHT 6% (1) BABY BEANNIES EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-645, 51 lots: 109030612 109030699 109051050 109051212 110061464 110071705 110081981 110082075 110092405 110112816 110122898 111010147 111020295 111030648 111041071 111051300 111061559 111071831 111092556 111102774 111112951 111112964 111123280 112010194 112010255 112030736 112052003 112083214 112093731 112104256 112114396 112125106 112125305 113015456 113025965 113036376 113047028 113057498 113078339 113078575 113099294 113099575 131110079 131110411 131110588 140111243 140211676 140211878 140412472 140412889 140513351 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices CESAREAN PACK- - (3) ABSORBENT TOWELS 15" x 20" LIF (1) PLASTIC BOWL WITH LID 80oz. (1 0) LAP SPONGES PRE-WASH 18" x 18" XRD (2) PAD OBSTETRICAL X-LARGE ST. (1) MAYO STAND COVER REINFORCED LIF (1) DRAPE SHEET 41" x 58" SMS LIF (2) TUBE SUCTION CONNECT. Y.." X 12' LIF (1) EAR ULCER SYRINGE 2oz. LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT L/F (1) UMBILICAL CORD CLAMP (1) SURGICAL BLADE #20 CARBON STEEL (1) TABLE COVER REINFORCED 50" X 90" LIF (1) GOWN IMPERVIOUS REINFORCED X-LARGE SMS LIF (1) DRESSING ISLAND 4" X 1 0" (1) C-SECTION DRAPE WITH POUCH 102" X 121" X 78" (1) BABY BLANKET PRINTED (1) GOWN IMPERVIOUS REINFORCED LARGE SMS (1) BAG SUTURE FLORAL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-660, 47 lots: 110061532 110071635 110071853 110102449 110112671 110122899 111010148 111020375 111030650 111040914 111051212 111061560 111071832 111082224 111092400 111102775 111112949 111123281 112010195 112020516 112030737 112041345 112052004 112062504 112083440 112093591 112093732 112114595 112125107 113015698 113025966 113036597 113036730 113057500 113057875 113068179 113088883 113099295 113109867 131110270 131110412 131110589 131210972 140111453 140211677 140211945 140513352 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices ARTHROSCOPY PACK - - (1) MAYO STAND COVER REINFORCED LIF (3) TOWELS ABSORBENT 15" X 20" LIF (1) STOCKINETTE IMPERVIOUS 14" X 48" LIF (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) BLADE SURGICAL # 11 STAINLESS STEEL (1) NEEDLE HYPODERMIC 21G X 1 ~ LIF (1) TUR Y SET 81" 2.1M REGULAR CLAM (1) NEEDLE HYPODERMIC 18G X 1 ~ (1) SHEET ARTHROSCOPY T STD SMS WITH POUCH LIF (1 0) GAUZE SPONGE 4" X 4" 16PL Y (1) SHEET DRAPE 70" X 100" LIF (1) *Pr. SURGEON NEUTRALON GLOVE #8 LATEX (2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS (1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF (1 ) TUBE SUCTION CONNECT. X" X 12' LIF (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6" X 21" (1 ) DURAPREP SURGICAL SOLUTION 26ML LIF (1 ) NEEDLE SPINAL ANEST. 18G X 3 %" LIF (2) ELASTIC BANDAGE 6" X 5YRD. LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) PAD ABDOMINAL 8" X 7.5" (1) *Pr. SURGEON NEUTRALON GLOVE #8 ~ LATEX EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-740, 20 lots: 112030744 112041351 112052010 112062505 112072876 112093641 112104101 112114588 112125111 113015457 113025967 113036380 113057877 113088887 113099452 113099576 131110272 131210839 140111248 140211735 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices ARTHROSCOPY PACK - (1) COVER MAYO STAND REINFORCED UF (1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF (1) TUBE SUCTION CONNECT ~" X 12' LIF (1) SHEET ARTHROSCOPY T STD SMS WITH POUCH LIF (1) STOCKINETIE IMPERVIOUS 14" X 48" LIF (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK L/F (1) BLADE SURGICAL# 11 STAINLESS STEEL (1) NEEDLE HYPODERMIC 21G X 1Y2 LIF (1) NEEDLE SPINAL ANESTH 18G X 3 Y2 LIF (1) PAD ABDOMINAL 8" X 7.5" LIF (2) ELASTIC BANDAGE WITH VELCRO 6" X 5yds LIF (1) TIME OUT BEACON NON WOVEN LIF (1) NEEDLE HYPODERMIC 18G X 1 Y2 L/F (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER LIF (1) COVER TABLE 44" X 90" LIF (1) COUNTER NDLIBLADE 20C FOAM/MAG L/F (3) TOWELS ABSORBENT 15" X 20" LIF (1) BAG SUTURE FLORAL (1) SHEET DRAPE 70" X 1 00" SMS LIF (1 0) GAUZE SPONGE 4" X 4" 16PL Y (1) SOLUTION SURGICAL DURAPREP 26ML LIF (1) GOWN IMPERVIOUS EXTRA REINFORCED LGE AAMI (1) TUR Y SET 81"2.1M REGULAR CLAM LIF LEVEL Ill TOWEL/WRAP LIF (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6" X 21" UF (1) GOWN XL SMS IMPERVIOUS REINFORCED AAMI LEVEL Ill LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-740A, 1 lots: 140312021 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices IMPLANTE DE ORTHOPEDIA- 1) GOWN IMPERV. XTRA REINF. XL SMS T/WRAP LEVEL IV (1) CAUTERY TIP POLISHER LIF (1) DURAPREP SURGICAL SOLUTION 26ml LIF (1) BAG SUTURE FLORAL LIF (1) TUBE SUCTION CONNECT. Y.!" X 12' L/F (1) CAUTERY PENCIL ROCKER SWITCH LIF (2) *Pr. SURGEON NEUTRALON GLOVE# 8 LATEX (2) BLADE SURGICAL# 10 STAINLESS STEEL (1) BAG GLASSINE (1) STOCKINETIE IMPERVIOUS 14" X 48" LIF (2) LITE GLOVE LIF (1) SPLIT SHEET W/ADHES 108" X 77" STD SMS UF (1) MAYO STAND COVER REINFORCED LIF (4) DRAPE UTILITY WITH TAPE LIF (5) ABSORBENT TOWELS 15" X 20" LIF (5) LAP SPONGES PRE-WASH XRD LIF (2) DRAPE SHEET 70" X 100" STD SMS LIF (1) MAYO TRAY LARGE (2) * Pr. SURGEON NEUTRALON GLOVE #8% LATEX (1) STAPLE SKIN WIDE 35 ST. LIF (1) TOP DRAPE W/ADHES. 108" X 50" STD SMS LIF (1) BULB SYRINGE 60cc (2) BANDAGE ELASTIC 6" X 5"yds LIF (2) UTILITY BOWL 32oz (1) UTILITY BOWL 16oz LIF (1) SKIN MARKER WITH RULER (1) INCISE DRAPE ANTIMICROBIAL 23" X 17" LIF (2) ABDOMINAL PAD 8" X 7 W (1) U-DRAPE 60" X 70" WIT APE SPLIT 6" X 21' (2) GOWN IMPERVIOUS REINFORCED XL (1) YANKAUER SUCTION TUBE WITHOUT VENT UF (2) COVER TABLE BTC 77" X 86" HD FULL COVERAGE EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-741, 16 lots: 112041352 112072877 112104102 113015459 113025775 113036381 113036466 113067962 113078344 113088941 113099578 113109870 131110274 131210840 140111249 140211736 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices ORTHO IMPLANT SURGICAL PACK - (1) CAUTERY TIP POLISHER (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6" X 21" (1) BAG SUTURE FLORAL (2) ABDOMINAL PAD 8" X 7 Y:z" (1) TUBE SUCTION CONNECT. }4" X 12' (1) DURAPREP SURGICAL SOLUTION 26ml (1) BAG GLASSINE (1) YANKAUER SUCTION TUBE WITHOUT VENT (2) LITE GLOVE (1) SPLIT SHEET WITH ADHES 1 08" X 77" STD SMS (2) COVER TABLE BTC 77" X 86" HD FULL COVERAGE (1) STOCKINETTE IMPERVIOUS 14" X 48" (1) MAYO STAND COVER REINFORCED (1) INCISE DRAPE ANTIMICROBIAL 23" X 17" (5) ABSORBENT TOWELS 15" X 20" (1) GOWN IMPERV. EXTRA REINFORCED XL SMS TNI/RAP LEVEL IV (4) DRAPE UTILITY (1) CAUTERY PENCIL ROCKER SWITCH (5) LAP SPONGES PREWASH XRD (1) GOWN IMPERVIOUS REINFORCED SMS X-LARGE (2) DRAPE SHEET 70" X 100" STD SMS (1) TIME OUT BEACON NON WOVEN (1) STAPLE SKIN WIDE 35 ST. (1) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER (1) MAYO TRAY LARGE (1) NEEDLE & BLADE COUNTER 20c FOAM/MAG (1) TOP DRAPE W/ADHES. 100" X 53" SMS (1) GOWN IMPERVIOUS EXTRA REINFORCED LARGE TOWEL WRAP (2) BANDAGE ELASTIC 6" X 5"yds (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK (1) UTILITY BOWL 16oz (1) NEEDLE HYPODERMIC 18G X 1Y2 (2) UTILITY BOWL 32oz (2) BLADE SURGICAL# 10 STAINLESS STEEL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-741A, 2 lots: 140412701 112104102 113015459 113025775 113036381 113036466 113067962 113078344 113088941 113099578 113109870 131110274 131210840 140111249 140211736 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices CARPALTUNNELLARGE - (1) TABLE COVER 50" X 90" REINFORCED LIF (1) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK LIF (1) UTILITY BOWL 32oz LIF (2) DRAPE SHEET 41 " X 58" SMS (1) BANDAGE GAUZE 4" STRETCH (1) NEEDLE HYPODERMIC 25G X 5/8" (1) STOCKINETTE 6" X 48" LIF (2) CLOTH HUCK TOWEL BLUE (1) GOWN SMS LARGE NON REINFORCED TOWEL/WRAP (1) GOWN SURGICAL REINF XL TOWEL/WRAP (1) NEEDLE HYPODERMIC 18G X 1 %" (10) GAUZE SPONGE 4" X 4" 16PLY XRD L.F (1) UTILITY BOWL 16oz LIF (1) ABSORBENT TOWELS 15" X 20" LIF (1) CAST PADDING (2) SURGICAL BLADE #15 STAINLESS STEEL (4) DRAPE UTILITY WITH TAPE L/F (1) SHEET EXTREMITY ABS. 125" x 85" SMS EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-742, 38 lots: 110092282 110112680 110122944 111010190 111020296 111041070 111061687 111071387 111071969 111082110 111092402 111102779 111113140 111123292 112010203 112020493 112030743 112041353 112052012 112062507 112093642 112104103 112114589 112125112 113015460 113025776 113025985 113036767 113067963 113068180 113088888 113099453 113109871 131110275 131210841 140111250 140211737 140311948 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices CARPAL TUNNEL SURGICAL LARGE PACK (1) COVER TABLE 44" X 90" LIF (1) NEEDLE HYPODERMIC 18G X 1 % LIF (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) BOWL UTILITY QUART 32oz. (2) SHEET DRAPE 41" X 58" SMS LIF (2) TOWELS ABSORBENT 15" X 20" LIF (1) BANDAGE GAUZE STRETCH 4" (1) NEEDLE HYPODERMIC 25G X 5/8 (2) BLADE SURGICAL #15 STAINLESS STEEL (2) TOWEL CLOTH HUCK BLUE LIF (1) PADDING CAST COTTON ROLL 2" X 4yds (1) STOCKINETTE 6" X 48" L/F (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (4) DRAPE UTILITY LIF (1) GOWN SURG. FABRIC REINFORCED X-LARGE AAMI Ill LIF (1) TIME OUT BEACON NON WOVEN (1) HAND DRAPE ORTHOARTSO 76" X 150" (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG L/F (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER (1) BAG SUTURE FLORAL L/F (1) GOWN IMPERVIOUS EXTRA REINFORCED LARGEL TOWEL/WRAP L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-742A, 4 lots: 140312026 140412702 140513380 140513481 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices NEURO PACK- (1)TABLE COVER 44" x 90" (1) GOWN SURGEON REINFORCED X-LARGE TIWRAP (1) GOWN IMPERVIOUS REINFORCED X-LARGE SMS (1) BAG SUTURE FLORAL (1) MAYO STAND COVER REINFORCED LIF (2) TOWELS ABSORBENT 15" X 20" LIF (4) DRAPE UTILITY WITH TAPE LIF (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (1) STOCKINETTE IMPERVIOUS 14" X 48" L/F (1) SHEET SPLIT WITH ADHESIVE 1 08" X 77" STD SMS LIF (1) TOP DRAPE WITH ADHESIVE 1 08" X 50" STD SMS L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-752, 37 lots: 109020288 109040862 109051218 109081882 109112704 110010111 110020448 110041015 110061538 110071775 110081984 110122945 111010161 111020378 111030658 111040919 111051388 111061566 111071943 111082111 111092403 111092464 111102780 111123294 112020512 112030745 112093950 112124705 112125113 113036768 113078345 113088889 113099454 113099588 113109872 120141354 131110277 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices GENERAL MINOR PACK- (1) MAYO STAND COVER REINFORCED LIF (2) BOWL UTILITY 16oz LIF (1) TIP CAUTERY POLISHER LIF (3) TOWELS ABSORBENT 15" X 20" LIF (1) BOWL UTILITY 32oz (1) BAG SUTURE FLORAL (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (10) GAUZE SPONGES 4" X 4" 16PLY XRD LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (2) GOWN IMPERVIOUS REINFORCED LARGE SMS LIF (1) CAUTERY PENCIL ROCKER SWITCH LIF (1) BLADE SURGICAL #10 STAINLESS STEEL (1) TUBE SUCTION CO NNECTING ~" X 12' LIF (5) LAP SPONGE PREWASH 18" X 18" XRD LIF (2) LITE GLOVES LIF (1) DRAPE LAPAROTOMY WITH POUCH 102" X 121" X 78" STD SMS (4) DRAPE UTILITY WITH TAPE LIF (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL (1) BLADE SURGICAL #15 CARBON STEEL (2) SHEET DRAPE 41" X 69" MEDIUM LIF (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-787, 25 lots: 109010128 112030747 112052015 112062577 112093733 112114397 112114483 112125114 113015516 113025969 113036383 113047206 113057819 113068181 113078606 113099296 113099577 131110278 131110606 131210973 140111454 140211879 140312331 140412842 140513251 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices FEMORAL ANGIOGRAPHY PACK - (1) TABLE COVER REINFORCED 50" X 90" UF (1) GOWN LARGE SMS IMPERVIOUS REINFORCED LIF (1) TOWEL ABSORBENT 15" X 20" UF (1) DRAPE ANGlO 75" X 145" (4) TOWELS CLOTH HUCK (BLUE) UF (3) SYRINGE 1 Occ WITHOUT NEEDLE LUER LOCK UF (1) IV ADM SET 15ML 1 06" LONG LIF (20) GAUZE SPONGE 4" X 4" 12PL Y LIF (1) NEEDLE HYPODERMIC 18G X 1Y:. ST. UF (1) NEEDLE HYPODERMIC 21G X 1Y:. ST. LIF (2) MEDICINE CUP 2oz. CLEAR LIF (1) SCALPEL WEIGHTED SAFETY #11 (2) CHLORASCRUB SWABSTICK 5.1 ML LIF (1) GOWN SURG REINFORCED LARGE TOWEL/WRAP LIF (1) SPECIMEN CONTAINER 4oz. W/LID & LABEL LIF (1) NEEDLE HYPODERMIC 25G X 5/8 ST. LIF (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF (1) FORCEP ADS ON TISS. WITH TIP LIF (1) UTILITY BOWL 32oz LIF (1) UTILITY BOWL 16oz L/F (1) FORCEP KELLY STRAIGHT 5.5" LIF (1) MOSQUITO HALSTED CVD 5" LIF (1) TRAY ORGANIZER FULL DEEP LIF (1) SCISSOR MAYO 6.75 STRAIGHT LIF (1) HOLDER NEEDLE WEBSTER 4.75 LIF (1) GUIDEWIRE .035" X 150cm UF (1) TIME OUT BEACON NON WOVEN ST. UF (1) MAYO TRAY SMALL LIF (2) TOWEL CLAMP UF (2) BAG BAND RUBBAND & TAPE LIF (1) Pr. GLOVE SURG. #7Y:. DERMA PRENE P/F LIF (2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF LABEL SAMPLE (1) NEEDLE & BLADE COUNTER 60C FOAM STRIP/MAG STRIP LIF (1) NEEDLE 18G X 2 o/.i AMC/4 (1) SKIN MARKER INK WITH/8 LABEL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-796, 14 lots: 113047032 113057507 113067965 113078346 113088892 113109873 131110279 131210842 140111251 140211700 140311949 140312388 140513145 140513340 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices LAPAROTOMY PACK - CONTENTS: ( 1) GOWN XL SMS IMPERVIOUS REINFORCED LIF ( 1) MAYO STAND COVER REINFORCED LIF (1) BAG SUTURE FLORAL LIF (4) DRAPE UTILITY WITH TAPE LIF (2) DRAPE SHEET 41 II X 58" SMS L/F ( 1) TABLE COVER 50" X 90" LIF ( 1) SOLUTION SURGICAL DURAPREP 26ML LIF (1) BLADE SURGICAL# 10 CARBON STEEL (5) LAP SPONGE PREWASH 18" X 18' XRD LIF (6) TOWELS ABSORBENT 15" X 20" LIF ( 1) CAUTERY TIP POLISHER L/F (2) UTILITY BOWL 16oz LIF (1) TUBE SUCTION CONNECT%" X 12' LIF (2) NEEDLE & BLADE COUNTER 10c MAG /CLEAR LIF (1) DRAPE T LAPAROTOMY 102" X 78" 121" SMS STD LIF ( 1) SPECIMEN CONTAINER 4oz WITH LID & LABEL ( 1) YANKAUER SUCTION TUBE WITHOUT VENT LIF ( 1) TIME OUT BEACON NON WOVEN LIF ( 1) GOWN SURG. REINFORCED XLGE TOWEL & WRAP LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-848, 23 lots: 112041259 112072813 112072916 112114685 112124855 112125308 113015569 113047034 113047207 113057642 113067938 113068189 113078590 113099301 113109648 113109876 131110346 140111253 140211856 140312186 140412473 140513146 140513482 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices CESAREAN PACK- (1) BEANNIES BABY LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) COVER MAYO STAND REINFORCED LIF (3) SHEET DRAPE 41 " X 58" SMS LIF (5) TOWEL ABSORBENT 15" X 20" LIF (15) SPONGE LAP PREWASH 18" X 18" XRD LIF (1) YANKAUER SUCTION TUBE W/0 VENT L/F (2) COUNTER NEEDLE & BLADE 10c MAG/CLEAR LIF (2) PAD OBSTETRICAL X-LARGE LIF (1) SYRINGE EAR/ULCER 2oz. L/F (1) BLANKET BABY PRINTED (1) TUBE SUCTION CONNECT Y-1" X 12' LIF (1) SYRINGE 20cc W/0 NEEDLE LUER LOCK LIF (1) BLANKET RECEIVING 100% COTTON (1) BOWL W/LID PLASTIC 80oz. (1) UMBILICAL CORD CLAMP (1) TUBE FEEDING PVC 8FR 15" LONG (1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED LIF (1) BAG SUTURE FLORAL (2) GLOVE MEDIUM FREETOUCH VYNIL POWDER FREE (1) SCALPEL W/HANDLE #1 0 (1) SCALPEL W/HANDLE #20 (2) BOWL UTILITY 16oz. LIF (1) PVP PAINT 8" STICK SPONGE LIF (1) GOWN SURG REINFORCED X-LARGE TOWEL/ WRAP LIF (1) PENCIL CAUTERY HAND SWITCHING LIF (1) SCISSOR UMBILICAL 4.5" STRAIGHT (1) WRAPPER 24" X 24" LIF (1) PVP SCRUB 8" STICK SPONGE LIF (1) DRAPE C-SECTION W/POUCH 102" X 121" X 78" LIF (1) TIME OUT BEACON NON WOVEN LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-851, 19 lots: 112093954 112114401 112125118 113015517 113046987 113047162 113057510 113067939 113078349 113088895 113099457 113109877 131110317 140111098 140211857 140312187 140412474 140513147 140513483 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices UROLOGY PACK- (2) SYRINGE 30ML SLIP TIP 1 ML LIF (2) GOWN SURG. REINFORCED LARGE TOWEL & WRAP (1 0) GAUZE SPONGE 4" X 4" 12 PLY (1) URINARY DRAINAGE BAG 2000ML ANTI-REFLUX LIF (1) TABLE COVER REINFORCED 44" X 78" LIF (1) DRAPE LITHO 110" X 63" SMS WITH LEGGINS (3) TOWELS ABSORBENT 15" X 20" LIF (1) TUR Y SET 81"2.1m REGULAR CLAM ST. (1) TUBE SUCTION CONNECT Y4" X 12' LIF (1) BAG SUTURE FLORAL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-868, 36 lots: 111030667 111040921 111051390 111061692 111071970 111082114 111092560 111102783 111123143 111123300 112010206 112020509 112030750 112041359 112052020 112083060 112093955 112114402 112114485 112114583 112125119 113015518 113015570 113036769 113057511 113078350 113088896 113099297 113109649 113109878 131210844 140111254 140211858 140412476 140412909 140513484 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices ARTHROSCOPY PACK- (2) ABSORBENT TOWELS 15" x 20" LIF (1) TUBE SUCTION CONNECT Y.." X 12' LIF (1) ELASTIC BANDAGE 6" X 5yrd. UF (1) IMPERVIOUS STOCKINETTE 14" X 48" (1) HUCK CLOTH TOWEL WHITE (1) MAYO STAND COVER REINFORCED LIF (1) U DRAPE 60" X70" WITH TAPE SPLIT (4) STRIPS TAPE 24" X 4" L/F (1) STOCKINETTE 6" X 48" LIF (1) MAYO TRAY SMALL (5) HUCK CLOTH TOWELS BLUE (2) UTILITY BOWL 32oz (2) GOWN SURGICAL REINFORCED X-LARGE LEVEL IV (1) SOLUTION SURGICAL DURAPREP 26ml UF (1) SHEET EXTREMITY ABS. 125" x 85" SMS (5) LAP SPONGE PREWASH XRD (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) PENCIL CAUTERY ROCKER SWITCH (1) SKIN MARKER INK WITH 8 LABEL (2) LITES GLOVES UF (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR (1) CAUTERY TIP POLISHER UF (4) DRAPE UTILITY WITH TAPE UF (1) BAG BIOHAZARD 30" X 37" (1) BAG SUTURE FLORAL (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE UF (1) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE TOWEL/WRAP EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-902, 11 lots: 112041360 112051755 112052021 113015521 113025983 113036389 113067942 113078352 140312189 140412917 140513342 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices CURATION KIT - CUSTOMED- (10) GAUZE SPONGE 4" X 4" 16PL Y (4) ABSORBENT TIP APPLICATOR (4) PVP PREP SOLUTION 1 oz (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL (2) EXAM GLOVES MEDIUM (1) WRAPPER 24" X 24" UF (1) PACKING TRAY EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-913, 16 lots: 112093762 112114486 112114882 113015699 113026117 113036390 113057375 113057513 113067943 113088899 113099460 113109881 131110318 140111257 140211861 140312190 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices PLASTIC SURGERY PACK- (1) MAYO STAND COVER REINFORCED LIF (1) CAUTERY TIP POLISHER LIF (1) BAG SUTURE FLORAL L/F (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (20) GAUZE SPONGES 4" X 4" 4PL Y (1) COVER TABLE REINFORCED 50" X 90" LIF (2) GOWN IMPERVIOUS REINFORCED LARGE SMS (1) PENCIL CAUTERY HANDSWITCHING L/F (1) TUBE SUCTION CONNECT. ~, X 12' LIF (1 0) LAP SPONGE PRE-WASH XRD LIF (2) LITE GLOVE LIF (4) HUCK CLOTH TOWEL BLUE (2) DRAPE SHEET MEDIUM 41" X 69" LIF (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR LIF (1) DRAPE LAP ABDOMINAL WITH POUCH STD SMS (5) Pk. STERI STRIP CLOSURE %"X 4" L/F (1) MAGNETIC INST. DRAPE (3) SKIN MARKER WITH RULER LIF (1) EXTENDED ELECTRODE BLADE (2) ABSORBENT TOWEL 15" X 20" LIF (4) UTILITY BOWL 32 oz (2) SURGEON GLOVES #8 BIOGEL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-920, 21 lots: 111051217 111092406 112030888 112052022 112093734 112114584 112125309 113015700 113036806 113057750 113078593 113089210 113099376 113099582 131010028 131110283 140111258 140211862 140312427 140412918 140513470 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices CESAREAN PACK- (1) COVER TABLE REINFORCED 50" X 90" (2) TOWELS ABSORBENT 15" X 20" (1) BABY BLANKET PRINTED (1) BOWL PLASTIC WITH LID 80oz. (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR (1) CORD UMBILICAL CLAMP (1) MUCUSTRAP 20cc, 10FR. (1) BOWL UTILITY 32oz (1) C-SECTION DRAPE WITH POUCH 102" X 121" X 78" (1) TUBE SUCTION CONNECT. ~"X 12' (1) TIP CAUTERY POLISHER (1) PENCIL CAUTERY ROCKER SWITCH (2) GOWN IMPERVIOUS REINFORCED LARGE SMS (1) MAYO STAND COVER REINFORCED (10) LAP SPONGES PREWASH 18" X 18" XRD (1) BAG GLASSINE (2) SURGICAL BLADE #10 STAINLESS STEEL (1) EAR ULCER SYRINGE 2oz. (2) LIGHT GLOVE (1) BOWL UTILITY 16oz (4) DRAPE UTILITY WITH TAPE (2) DRAPE SHEET 41 " X 58" SMS (1) ELECTRODE DUAL DEPRES./GROUNDPAD EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-921, 16 lots: 110061474 112114590 113026118 113036391 113057414 113057820 113078478 113078607 113099298 113099579 131110080 131110413 131110590 131210974 140111455 140211743 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices C-SECTION SURGICAL PACK- (1) COVER TABLE REINFORCED 50" X 90" (2) TOWELS ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) BABY BLANKET PRINTED (1 0) LAP SPONGES PREWASH 18" X 18" XRD (1) BOWL PLASTIC WITH LID 80oz. (1) BAG GLASSINE (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR (1) CORD UMBILICAL CLAMP (2) LIGHT GLOVE (1) BOWL UTILITY 32oz (1) BOWL UTILITY 16oz (4) DRAPE UTILITY (1) TUBE SUCTION CONNECT. 1!4" X 12' (1) TIP CAUTERY POLISHER (1) MUCUSTRAP 20cc, 10FR. (2) DRAPE SHEET 41" X 58" SMS (2) GOWN IMPERVIOUS EXTRA REINFORCED LARGE (1) PENCIL CAUTERY ROCKER SWITCH (1) ELECTRODE DUAL DEPRES./GROUNDPAD (1) C-SECTION DRAPE WITH POUCH 102" X 121" X 78" (1) EAR ULCER SYRINGE 2oz (1) BABY BEANNIES (1) RECEIVING BLANKET 100% COTTON (2) SURGICAL BLADE #10 STAINLESS STEEL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-921A, 4 lots: 140312028 140412706 140513148 140513469 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices CATARACT PACK- OJOS INC.- (1) TABLE COVER REINF. 44" X 78" L/F (2) MEDICINE CUP 1oz. (2) ABSORBENT TOWEL 15" X 20" LIF (1 0) EYE SPEAR MICRO SPONGE (1) EYE PAD 2 1/8 X 2 5/8 LIF (4) DRAPE UTILITY LIF (1) EYE SHIELD UNIVERSAL (2) GOWN LGE STANDARD SMS VELCRO/NECK (1) MAYO STAND COVER REINF. LIF (1) EYE DRAPE LIF (1) SYRINGE 3cc W/0 NDL L/LOCK LIF (1) WIPE INSTRUMENT 1MM L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-944, 63 lots: 110010120 110010151 110020418 110020489 110020494 110040959 110040961 110041046 110041047 110061499 110061544 110071716 110071717 110071807 110071808 110092290 110092318 110092409 110092412 110112786 110112787 110122904 110122905 111010173 111010179 111020306 111030826 111040980 111051219 111061648 111071971 111082117 111092408 111102641 111102787 111123307 112010211 112020471 112030755 112030944 112041363 112052025 112062574 112083442 112104089 112114686 113025972 113036598 113047119 113047149 113057515 113057821 113068182 113078576 113099299 113099580 131210848 131210975 140111456 140211881 140312387 140412843 140513353 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices STRABISMUS & PLASTIC PACK - (1) TABLE COVER REINFORCED 44" X 78" UF (2) GOWN STANDARD LARGE SMS (3) TOWELS ABSORBENT 15" X 20" UF (1) MAYO STAND COVER REINFORCED UF (1) DRAPE SHEET 41" X 58" SMS (4) DRAPE UTILITY WITH TAPE L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-946, 46 lots: 109010131 109020438 109030630 109030725 109061221 109061458 109081891 109102354 109112606 109122828 110010121 110020416 110030690 110041052 110071718 110092291 110092375 110112686 110122949 111010174 111020307 111040981 111051220 111061571 111071946 111082118 111092409 111102788 112010212 112020507 112030756 112041364 112052026 112072879 112083443 112093956 112114687 112125122 113025973 113036807 113057516 113089090 113109650 113109883 140111260 140111318 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices ARHTROSCOPY PACK- (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (1) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE (1) TOWEL ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) TABLE COVER REINFORCED 50" X 90" (1) BAG SUTURE FLORAL (1) STOCKINETTE IMPERVIOUS 14" X 48" (4) STRIPS TAPE 24" X 4" (1) SHEET EXTREMITY ABS. 125" X 85" (1) TIME OUT BEACON NON WOVEN ST. EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-982, 11 lots: 112093957 112114688 112125123 113025981 113067944 113078479 113088900 113109884 131110285 140111261 140412707 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices LAPAROTOMY PACK- (1) MAYO STAND COVER REINFORCED LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (5) LAP SPONGES PRE-WASH 18" X 18" XRD LIF (1) LITE GLOVE LIF (1) BAG SUTURE FLORAL (1) BLADE SURGICAL #1 0 CARBON STEEL (1) BLADE SURGICAL #15 CARBON STEEL (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) CAUTERY TIP POLISHER LIF (1) BAG GLASSINE (1) TABLE COVER 44" X 90" L/F (2) DRAPE SHEET 41 " X 58" SMS (1) LAPAROTOMY DRAPE "T" 102" X 78" X 121" STD SMS (4) DRAPE UTILITY WITH TAPE LIF (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF (1) TUBE SUCTION CONECT W' X 12' LIF (3) ABSORBENT TOWELS 15" X 20" LIF (1) CAUTERY PENCIL PUSH BOTTON (1) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE TOWEL/WRAP LEVEL Ill (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-996, 34 lots: 111040982 111051305 111061694 111071947 111082120 111092410 111092465 111102789 111113147 111123308 112010213 112020496 112030757 112041365 112052027 112072880 112083444 112093958 112114585 112125124 113025974 113036393 113057517 113057612 113057822 113078480 113078577 113099300 113099581 131110081 131110607 140111262 140211738 140513485 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices PERl GYN PACK (1) TABLE COVER 44" x 90" (2) LEGGINS W/7" CUFF 30" x 42" (1) ABDOMINAL DRAPE WITH TAPE LIF (2) TOWELS ABSORBENT 15" X 20" (10) GAUZE SPONGE 4" X 4" 16PLY (2) DRESSING NON ADH TELFA 4" X 3" (1) ROBINSON RED CATHETER 14FR. (1) UNDERBUTTOCK DRAPE WITH POUCH EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-997, 54 lots: 109010132 109020292 109061223 109061459 109081892 109092100 109102355 109112608 109122830 110010122 110030692 110030798 110061476 110071720 110081986 110092293 110092410 110112818 111010176 111020308 111030676 111041119 111051306 111061572 111071842 111082121 111082231 111092411 111102790 111113148 111123310 112020497 112030758 112041366 112052028 112072881 112083445 112093959 112104309 112125125 113015522 113025975 113026120 113036394 113057518 113078481 113088901 113099461 113109885 140111263 140211865 140312193 140412708 140513386 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices C-SECTION PACK - (1) TABLE COVER REINFORCED 50" X 90" L/F (3) TOWELS ABSORBENT 15" X 20" L/F (1) BABY BLANKET (1 0) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) GOWN SURG. SMS POLY-REINF BREATHABLE IMPERV XL T/ WRAP LEVEL IV (2) PAD OBSTETRICAL XL LIF (1) LITE GLOVE LIF (1) DRAPE SHEET 41" X 69" MEDIUM LIF (2) SURGICAL BLADE #10 CARBON STEEL (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) BAG GLASSINE (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR (1) CONTAINER 64oz WITH LID (1) SYRINGE 1 Occ WITHOUT NEEDLE LUER LOCK UF (1) MAYO STAND COVER REINFORCED UF (1) BAG SUTURE FLORAL (15) LAP SPONGES PRE-WASH XRD LIF (1) EAR ULCER SYRINGE 2oz UF (1) CORD UMBILICAL CLAMP L/F (1) WASH BASIN ?QT. (1) CAUTERY TIP POLISHER LIF (1) YANKAUER SUCTION TUBE W/0 VENT LIF (1) C-SECTION DRAPE WITH POUCH 102" X 121" X 78" (1) FEEDING TUBE 8FR. 15" LONG (4) DRAPE UTILITY WITH TAPE UF (1) TUBE SUCTION CONNECT. Y." X 12' UF (2) GOWN SURG. SMS POLY-REINF BREATHABLE IMPERVIOUS XL LEVEL IV EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-998, 30 lots: 110102460 110112688 110123134 111010177 111020380 111040983 111051307 111061695 111071843 111082122 111092412 111092562 111102894 111123312 111123473 112020498 112030759 112041367 112072882 112083446 112093766 112114689 112125126 113026063 113036770 113078482 113109886 140111264 140311950 140412910 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices OB PACK - (1) BABY BLANKET PRINTED (1) BABY BEANIES (1) TABLE COVER REINFORCED 50" X 90" LIF (2) LEGGINS W/7'' CUFF 30" X 42" LIF (1) DRAPE UNDERBUTIOCK W/ POUCH 44" X 35" LIF (3) TOWEL ABSORBENT 15" X 20" LIF (1) DRAPE SHEET 41 " X 58" SMS LIF (2) PAD OBSTETRICAL X-LARGE LIF (1) RECEIVING BLANKET 100% COTTON (1) PVP SCRUB 8" STICK SPONGE (1) FEEDING TUBE BFR, 15" LONG LIF (1) BOWL PLASTIC 80oz WITH LID (1) CORD UMBILICAL CLAMP (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) SYRINGE 20cc SLIP TIP LIF (1) GOWN LARGE SMS IMPERVIOUS REINFORCED LIF (1) NEEDLE HYPODERMIC 18G X 1% (1) NEEDLE HYPODERMIC 22G X 1% (20) GAUZE SPONGE 4" X 4" 16PL Y (1) EAR ULCER SYRINGE 2oz LIF (1) DRAPE ABDOMINAL WITH TAPE 40" X 54" LIF (2) GLOVE MED FREETOUCH VYNIL POWDER FREE (1) WRAPPER 24" X 24" L/F (1) GOWN IMPERVIOUS EXTRA REINFORCED LARGE TOWEL/WRAP LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1030, 18 lots: 112041230 112072809 112093846 112104130 112114918 113026212 113036313 113047310 113057379 113067853 113078668 113109703 131110148 131210674 140111136 140211630 140311913 140513060 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices ARTHROSCOPY PACK - (1) SURGICAL DURAPREP SOLUTION 26ML LIF (1) ESMARK BANDAGE (1 ) ELASTIC BANDAGE 6" X 5yds LIF (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG (1) TUBE SUCTION CONNECTING W X 12' LIF (1) SHEET EXTREMITY ABS. 125" X 85" SMS (1) DRAPE LASER CAMERA W/EL (3) TOWELS ABSORBENT 15" X 20" LIF (2) CONTAINER SPECIMEN 4oz. WITH LID & LABEL (1) BABY BLANKET IMP. POLY ABS. LIF (1) NEEDLE HYPODERMIC 20G X 1%'' (10) GAUZE SPONGES 4" X 4" 16PLY (1) BLADE SURGICAL #11 CARBON STEEL (1) TABLE COVER REINFORCED 50" X 90" LIF (1) IMPERVIOUS STOCKINETTE (1) SHEET DRAPE 42" X 55" LIF (1) SUTURE BAG FLORAL LIF (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (1) MAYO STAND COVER REINFORCED LIF (2) GOWN IMPERVIOUS REINFORCED SMS LARGE (4) STRIPS TAPE (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) GAUZE KERLIX 4.5 X 4.1 YO 6PL Y (1) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE TOWEL & WRAP EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1042, 12 lots: 113026163 113036737 113046994 113057378 113078232 113078669 113089153 113109704 131110065 131110610 140111137 140312045 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices LAPAROSCOPY CHOLE PACK - (4) DRAPE UTILITY WITH TAPE LIF (2) ABSORBENT TOWELS 15" X 20" LIF (2) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE LIF (1) SURGICAL DURAPREP SOLUTION 26ml LIF (1) TUR Y SET 81 "2.1M REGULAR CLAM ST. (1) DRAPE LASER CAMERA W/EL 6" X 96" (1) LAPAROSCOPY ABDOMINAL DRAPE W/POUCH L/F (1) TABLE COVER 44" X 90" (1) MAYO STAND REINFORCED L/F (1) SURGICAL BLADE # 11 CARBON STEEL (1 0) GAUZE SPONGES 4" X 4" 16PL Y XRD LIF (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR L/F (1) TUBE SUCTION CONNECTING W' X 12' LIF (1) TROCAR ENDOPATH XCEL DILATING TIP 5MM(K5LT) LIF (1) CEF AZOLIN RED LABEL (1) GENTAMICIN GREEN LABEL (1) AZUL DE METILENO LABEL (1) HEPARINE WHITE LABEL (1) LIDOCAINE YELLOW LABEL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1059, 16 lots: 112030823 113047111 113057410 113057823 113078454 113078566 113099561 113109983 131110149 131110397 131110577 131210955 140211914 140312430 140513062 140513474 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices PERl GYN PACK- (1) DRAPE UTILITY WITH TAPE UF (2) TOWELS ABSORBENT 15" X 20" UF (1) TOP DRAPE WITH ADHESIVE STD SMS (1) CATHETER NELATON ROB. 14FR. (2) GOWN IMPERVIOUS EXTRA REINFORCED XL (1) UNDERBUITOCK DRAPE WITH POUCH (2) LEGGINS WITH 7" CUFF 30" X 42" (1) TABLE COVER REINFORCED 44" X 78" UF (1 0) GAUZE SPONGES 4" X 4" 16PL Y XRD LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1061, 43 lots: 110051144 110061480 110071614 110082107 110102421 110112595 110123081 111010014 111020502 111030541 111030814 111040868 111061579 111071751 111082041 111082267 111092342 111102654 111112942 112020305 112051670 112062315 112072764 112083153 112093849 113025926 113026038 113036447 113046995 113047194 113057377 113057824 113068139 113078455 113099265 113099585 131110150 131210675 131211024 140311916 140312431 140412826 140513473 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices ARTHROSCOPY PACK- (1) VIDEO CAMERA DRAPE 13cm X 244cm LIF (2) BANDAGE ELASTIC 6" X 5yrd. LIF (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (1) DURAPREP SURGICAL SOLUTION 26m I LIF (1) STOCKINETIE IMPERVIOUS (1) TUBE SUCTION CONNECT. 3/16" X 12' LIF (1) SHEET ARTHROSCOPY T STD SMS WITH POUCH LIF (1) BAG SUTURE FLORAL LIF (1) BLADE SURGICAL #11 CARBON STEEL (2) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE LIF (1) SYRINGE 30cc SLIP TIP LIF (1) TABLE COVER 44" x 90" (1) MAYO STAND COVER REINFORCED LIF (4) TOWELS ABSORBENT 15" X 20" LIF (5) LAP SPONGES PRE-WASH XRD UF (1) DRAPE SHEET 41 " x 58" SMS UF (1) NEEDLE HYPODERMIC 22G X 1 Y:z (1) NEEDLE HYPODERMIC 18G X 1 Y:z (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (10) GAUZE SPONGES 4" X 4" 16PL Y EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1062, 16 lots: 109071569 112072765 112083154 113057380 113057684 113057854 113078233 113078670 113089154 113099586 131110151 131110593 131210956 140412452 140513063 140513390 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices PERY GYN PACK- CUSTOMED- (1) DRAPE ABDOMINAL WITH TAPE UF (1) TOWEL ABSORBENT 15" X 20" UF (2) LEGGINGS W/7" CUFF 30" X 42" (1) TABLE COVER REINFORCED 44" X 78" UF (1) DRAPE UNDERBUTTOCK WITH POUCH EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1091, 56 lots: 110020286 110030631 110040867 110051180 110071617 110081956 110092110 110092379 110112598 110123050 111010018 111020258 111020449 111030543 111051225 111051262 111061481 111071752 111071879 111082042 111092470 111102655 111112944 111112979 111123313 112010019 112020307 112030825 112041390 112041451 112051726 112062316 112072825 112083159 112083381 112093855 112124920 113015425 113025927 113026164 113036314 113047314 113057381 113057855 113078235 113078673 113099267 131110152 131110594 131210957 140111404 140211917 140312390 140412827 140513064 140513451 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices FOLEY CATHETER KIT 1116FR. - CUSTOM ED- (1) WRAPPER 24" X 24" (1) PVP TRIPLE SWABSTICK IODOPHOR (2) GLOVE MED FREETOUCH VYNIL P/F (1) JELLY LUBRICATING 5 GRAM (1) TOWEL 3PLY POLY 17" X 18" (2) SWABSTICK DRY COTTON (1) DRAPE 4" FENESTRATED 18" X 26" (1) CATHETER 16FR. FOLEY, 2 WAY,5cc, Silicone Coated (1) SYRINGE 10cc WATERPREFIL UF (1) BAG URINARY DRAINAGE 2000ML ANTI-REFLUX UF (1) LABEL ID PATIENT (1) TRAY ORGANIZER (1) SPECIMEN CONTAINER 4oz. W/LID & LABEL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1127, 27 lots: 111082044 111092578 111102824 111112983 111123318 112020311 112030602 112041178 112072767 112083205 112093744 113015572 113025906 113036449 113047145 113068141 113088830 113099339 131110626 131210624 140111138 140211532 140211883 140412442 140412828 140513066 140513253 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices FOLEY CATHETER KIT 1118FR.- CUSTOM ED CONTENTS: (1) WRAPPER 24" X 24" (1) LABEL ID PATIENT (1) TRAY ORGANIZER (1) PVP TRIPLE SWABSTICK IODOPHOR (2) GLOVE MED FREETOUCH VYNIL P/F (1) JELLY LUBRICATING 5 GRAM (1) TOWEL 3PL Y POLY 17" X 18" (2) SWABSTICK DRY COTTON (1) DRAPE 4" FENESTRATED 18" X 26" (1) CATHETER FOLEY 18FR, 2WAY SILICONE COATED m SYRINGE 10ccWATERPREFIL UF (1) BAG URINARY DRAINAGE 2000ML ANTI-REFLUX UF (1)SPECIMEN CONTAINER 4oz W/LID & LABEL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1139, 13 lots: 111112985 111123474 112010023 112041179 112072768 112083208 112093742 112103742 112114377 113015573 113109708 140211533 140412580 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices NEURO PACK - (1) CAUTERY TIP POLISHER LIF (4) DRAPE UTILITY WITH TAPE LIF (1) INSTRUMENT POUCH (10) LAP SPONGE PRE-WASH XRD (1) Pk. SURGICAL STRIP W' X 6" (2) UTILITY BOWL 32oz (1) MAYO TRAY LARGE (9) SHEET DRAPE 41 " X 69" MEDIUM LIF (1) NEEDLE HYPODERMIC 18G X 1 LIF (3) CONTAINER SPECIMEN 4oz WITH LID & LABEL (2) Pr. SURGICAL GLOVES 7 Y2 (2) Pr. SURGICAL GLOVES 8 (2) EAR ULCER SYRINGE 2oz LIF (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) SHEET MINOR LAP 102" X 121" X 78" (1) SAFETY SCALPEL #10 (2) SYRINGE 60ML WITHOUT NEEDLE LUER LOCK LIF (4) CLOTH HUCK TOWELS BLUE (1) PENCIL CAUTERY ROCKER SWITCH (2) LEGGINS W/7'' CUFF 30" X 42" (1) DRAPE% ECONOMY 53" X 77" LIF (1) Pk. SURGICAL STRIP 'X" X 6" (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR L/F (2) ROUND WASH BASIN 6QT (2) GOWN SURG. REINFORCED TOWEL/WRAP LARGE (2) Pr. SURGICAL GLOVES 7 (1) SKIN MARKER WITH RULER LIF (1) Pk. STERI STRIP CLOSURE %"X 4" LIF (1) TUBE SUCTION CONNECT. 'X" X 12' LIF (1) SAFETY SCALPEL #15 (1) SAFETY SCALPEL #11L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1146, 36 lots: 109051127 110040868 110051198 110092116 110092352 110102423 111010024 111030547 111051146 111061483 111082046 111092345 111102659 111112945 111123320 112010025 112010277 112020314 112041069 112051672 112082330 112083209 112093735 112124923 113015489 113015687 113026040 113026202 113078237 131110156 131210626 140111140 140111777 140412582 140513068 140513475 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices PHACO PACK - (10) GAUZE SPONGE 4" X 4" 12PLY (2) SYRINGE 3cc W/NDL. 21G X 1 %" (2) MEDICINE CUP 2 oz. (1) OPHTHALMIC DRAPE W/POUCH (1) GOWN STANDARD LGE.SMS (1) GOWN NON REINF. Lge. T/Wrap SMS (1) EYE SHIELD UNIVERSAL (1) TABLE COVER 44" X 90" (1) MAYO STAND COVER REINF. LIF (3) ABSORBENT TOWEL 15" x 20 LIF (2) EYE PAD 2 1/8 X 2 5/8 LIF (1 0) EYE SPEAR MICRO SPONGE VELCRO/NECK EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1156, 12 lots: 109122834 110010026 110020379 110020559 110040869 110041086 110051182 110061483 110071624 110081995 110092119 110102582 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices LAP AROSCOPY PACK - (10) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF (1) MAYO STAND COVER REINFORCED L/F (4) ADHESIVE BANDAGE%" X 3" ST. LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (2) GOWN IMPERVIOUS REINFORCED LARGE SMS (2) TOWEL ABSORBENT 15" X 20" LIF (1) DRAPE LASER CAMERA W/EL 6" X 96" LIF (2) LITE GLOVE LIF (1) TUBE SUCTION CONNECTING W X 12' LIF (1) DRAPE LAP WITH POUCH 102" X 121 " X 78" STD SMS (1) BLADE SURGICAL #11 STAINLESS STEEL (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (4) DRAPE UTILITY WITH TAPE L/F (1) BAG SUTURE FLORAL (1) TUR Y SET, 2 LEAD L/F (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR LIF (1) GOWN STANDARD LARGE SMS VELCRO NECK (1) TUBE SUCTION CONNECT 3/16" X 12' LIF (1) Pk. STERI STRIP LAP. LATEX (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL (1) CAUTERY PENCIL ROCKER SWITCH LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1176, 21 lots: 112051673 112051735 112062336 112083210 112093723 112114597 112114925 113025928 113036747 113078239 113078679 113089017 113099562 140111074 140211461 140211717 140312052 140312421 140412913 140513071 140513476 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices LAPAROSCOPY OB GYN PACK - (1) DURAPREP SURGICAL SOLUTION 26ML LIF (1) SHEET T LAPAROSCOPY SMS LIF (2) DRAPE UTILITY WITH TAPE LIF (1) DRAPE SHEET 41" X 58" SMS LIF (4) ABSORBENT TOWELS 15" x 20" LIF (1) PVP TRIPLE SWABSTICK IODOPHOR (1) DRAPE LASER CAMERA W/EL 6" X 96" (1) TUBE SUCTION CONNECT.%" X 12' LIF (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF (1) SURGICAL BLADE #11 CARBON STEEL (1) TABLE COVER 44" X 78" REINFORCED LIF (1) TEGADERM TRANS DRESSING 6" X 8" (2) LEGGINS WITH 7" CUFF 30" X 42" (10) GAUZE SPONGES 4" X 4" 12PLY XRD (1) BAG URINARY DRAINAGE 2000ML ANTI-REFLUX (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR LIF (1) TUR CYSTO IRRIGATION SET 79" (1) FOLEY CATHETER 16FR 2WAY, 5CC (2) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK LIF (2) GOWN IMPERVIOUS EXTRA REINF XLG LIF (1) TROCAR ENDO. XCEL DILATING TIP 5MM (K5LT) (1) PNEUMO INSUFLAT NEEDLE 150MM LUER LOCK LIF (1) CEFAZOLIN RED LABEL (1) GENTAMICIN GREEN LABEL (1) AZUL DE METILENO LABEL (1) HEPARINE WHITE LABEL (1) LIDOCAINE YELLOW LABEL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1192, 10 lots: 113057752 113067947 113078458 113078680 113099381 140211710 140312054 140412584 140513072 140513334 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices LAMINECTOMY PACK - ( I) RING BASIN LIF (2) TABLE COVER REINFORCED 50" X 90" LIF ( I) SKIN MARKER INK W/8 LABEL ( I) CAUTERY TIP POLISHER LIF ( I) TUBE SUCTION CONNECT. W' X 12' LIF (6) DRAPE UTILITY W/TAPE LIF (I 0) GAUZE SPONGE 4" X 4" 16PL Y LIF (2) UTILITY BOWL 16oz. LIF ( IO) LAP SPONGE PRE-WASH XRD LIF (2) SPECIMEN CONTAINER 4oz W/LID & LABEL (2) MAYO STAND COVER REINFORCED LIF ( I) GOWN SURG. REINF. XL TOWEL WRAP (6) ABSORBENT TOWEL I5" X 20" LIF ( I) DRAPE LAP 102" X 121" X 78" W/POUCI-1 SMS LIF ( I) SURGICAL DURAPREP SOLUTION 26ML LIF (6) DRAPE SHEET 41" X 69" MEDIUM LIF (2) LEGGING W/7'' CUFF 30" X 42" LIF (2) NEEDLE & BLADE COUNTER I Oc MAG /CLEAR ( I) CAUTERY PENCIL PUSH BOTTOM LIF ( I) BAG SUTURE FLORAL LIF ( I) PVP SCRUB 8" STICK SPONGE ( I) MAYO TRAY LARGE LIF (I 0) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF ( I) SURGICAL BLADE# I 0 CARBON STEEL (2) BULB SYRINGE 60cc CLEAR LIF ( I) SURGICAL BLADE# I I CARBON STEEL ( I) SURGICAL BLADE # 15 CARBON STEEL ( I) GOWN FABRIC REINFORCED SONTARA XL LIF ( I) SYRINGE IOcc W/NDL 20G X I Y, LILOCK LIF ( I) PVP PAINT 8" STICK SPONGE ( I) SURGICAL STRIP W' X 6" COTTON (2) LITE GLOVES LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1202, 12 lots: 112051738 113078681 113099269 113109712 131110160 131210629 140111078 140211462 140211633 140311918 140412586 140513335 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices OB PACK - (2) EXAM GLOVES MED. (1 0) GAUZE SPONGES 4" X 4" 12PL Y (2) LEGGINS W/ 7" CUFF (2) DRAPE SHEET SMS (1) ABDOMINAL DRAPE W/TAPE (1) PLASTIC BOWL W/Lid 70 oz. (1) EAR/ULCER SYRINGE 2oz. L/Free (1) UMBILICAL CORD CLAMP (1) BABY BEANNIES (1) PVP SCRUB 8" STICK SPONGES (1) MEASURE DISP. PAPER TAPE 24" (1) IMP .REINFORCED GOWN XLge. SMS STERILE (1) TABLE COVER Reinf. L/Free (1) SYRINGE 1cc W/NDL. 25G X 5/8 SLIP TIP L/Free (2) PAD OBSTETRICAL XLGE ST. (1) UNDERBUTTOCK DRAPE W/POUCH (1) SYRINGE 10cc W/0 NDL. L/Free (1) SYRINGE 20cc W/ONDL. L/Lock L/Free (1) FEEDING TUBE 8 Fr. 15" LONG (1) BABY BLANKET IMP. POLY ABS. (1) NEEDLE HYPODERMIC 23GA X 1" (6) ABSORBENT TOWELS L/Free (1) WRAPPER 24" X 24" EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1238, 1 lots: 109071538 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices PREMIUM OPHTHALMIC PACK- CUSTOMED- (1) GOWN SMS X-LARGE STD RAGLAN (1) CUP MEDICINE 2oz (1) DRAPE OPHTHAL. WITH POUCH LIF (1 0) SPONGE EYE SPEAR MICRO (1) SHIELD EYE UNIVERSAL (6) COTTON TIP APPLICATION 6" WOOD LIF (1 0) GAUZE SPONGES 4"X 4" 12PL Y (2) TOWELS ABSORBENT 15" x 20" LIF (1) COVER MAYO STAND REINFORCED LIF (1) SYRINGE 1 ML WITHOUT NEEDLE LUER LOCK LIF (1) COVER TABLE REINFORCED 50" x 90" LIF (1) SYRINGE 3cc WITH NEEDLE 21 G X 1 % LIF (1) GOWN LARGE SMS NON REINFORCED TOWEL/WRAP EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1293, 7 lots: 110092130 111041087 112020325 112051676 112051745 112062348 112083385 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices PREMIUM CESAREAN PACK- CUSTOMED- (1)BABY BLANKET IMP. 30" X 30" POLY ABSORBENT (3) TOWELS ABSORBENT 15" X 20" LIF (1) BOWL PLASTIC 80oz WITH LID (10) LAP SPONGE PREWASH XRD LIF (2) PAD OBSTETRICAL X-LARGE ST. (1) MAYO STAND COVER REINFORCED LIF (1) DRAPE SHEET 41 " X 58" SMS LIF (1) TUBE SUCTION CONNECT. X" X 12' LIF (1) EAR ULCER SYRINGE 2oz LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) CORD UMBILICAL CLAMP LIF (1) DRESSING ISLAND 4" X 10" (1) BLADE SURGICAL#10 CARBON STEEL (1) BLADE SURGICAL#20 CARBON STEEL (1) TABLE COVER REINFORCED 50" X 90" LIF (1) C-SECTION DRAPE WITH POUCH (1) GOWN IMPERVIOUS REINFORCED X-LARGE SMS AAMI III (1) GOWN SURG. REINFORCED LARGE AAMI III TOWEL WRAP EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1294, 18 lots: 111030560 111030815 112020527 112114630 112124933 113015688 113026042 113036408 113057858 113089182 113109717 131110166 131210694 140211638 140312063 140412594 140513078 140513477 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices PREMIUM UROLOGY PACK - CUSTOMED- (1) LITHOTOMY DRAPE W/POUCH ANESTH. (2) ABSORBENT TOWELS UF (1) MAYO STAND COVER REINFORCED UF (1) URINARY DRAINAGE BAG 2000ml ANTI-REFLUX UF (1) GOWN SURG. REINFORCED LARGE T/WRAP (1) UTILITY BOWL 32 OZ. (1) TUBE SUCTION CONNEC. W' X 12' UF (1) TABLE COVER REINFORCED 50" X 90" UF (1) TUR Y SET 81 "2.1M REGULAR CLAM ST. (1) GOWN XL SMS IMPERVIOUS REINFORCED (1) SPECIMEN CONTAINER 4oz. W/LID & LABEL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1295, 2 lots: 111030561 112031009 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices PREMIUM LAPAROTOMY PACK - CUSTOMED- (1) DRAPE T LAPAROT 102" X 78" X 121" (1) GOWN XL SMS IMPERVIOUS REINFORCED (1) COVER TABLE REINFORCED 50" X 90" LIF (1) COVER MAYO STAND REINFORCED LIF (4) DRAPE UTILITY WITH TAPE LIF (4) TOWELS ABSORBENT 15" X 20" LIF (5) SPONGE LAP PRE-WASH 18" X 18" XRD LIF (1) YANKAUER SUCTION TUBE W/0 VENT LIF (1) TUBE SUCTION CONNECT~~~ X 12' LIF (1) BLADE SURGICAL #10 CARBON STEEL (1) BLADE SURGICAL #15 CARBON STEEL (1 0) GAUZE SPONGES 4" X 4" 16PL Y XRD LIF (2) DRAPE SHEET 42" X 55" LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. (1) GOWN SURG REINFORCED LARGE TOWEL/WRAP Product code 900-1296, 51 lots: 110102576 110112604 110112865 110122889 110123065 111010033 111020358 111030562 111030827 111030934 111041085 111051267 111051325 111061488 111061600 111061645 111072036 111082183 111082197 111092481 111102671 111112927 111123333 112010033 112010243 112020326 112030613 112041246 112041437 112062581 112114631 112124934 112125280 113015634 113025909 113036727 113047212 113047323 113068143 113078567 113078691 113089183 113109718 131110066 131110595 131210958 140111405 140211870 140412595 140412882 140513344 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices PREMIUM O.B. PACK - CUSTOMED- (1) TABLE COVER REINFORCED 50" X 90" LIF (10) GAUZE SPONGES 4" X 4" 12PLY LIF (2) LEGGINS WITH 7" CUFF 30" x 42" LIF (2) PAD OBSTETRICAL X-LARGE ST. (2) SHEET DRAPE 42" X 55" LIF (1) UNDERBUTTOCK DRAPE WITH POUCH LIF (1) DRAPE ABDOMINAL 40" X 54" WITH TAPE LIF (1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED LIF (1) BOWL PLASTIC 80oz WITH LID (1) EAR ULCER SYRINGE 2oz LIF (1) CORD UMBILICAL CLAMP LIF (1) BABY BLANKET IMP. 30" X 30" POLY ABS. LIF (1) TOWELS ABSORBENT 15" X 20" LIF (1) LAP SPONGE PRE-WASH 18" X 18" XRD LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1297, 44 lots: 109030542 110061517 110071663 110081957 110082065 110082132 110112605 110112866 110123051 110123066 111030563 111071760 111082184 111082268 111092487 111102647 111102672 111112928 111112962 111123334 112010034 112020327 112041184 112062405 112062406 112062582 112062620 112083387 112114633 112124935 113015426 113025935 113036315 113036450 113047324 113068144 113078692 113109719 131110167 131110596 131210959 140111406 140412596 140513080 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices PREMIUM ARTHROSCOPY PACK - CUSTOMED- (1) ARTHROSCOPY SHEET T WITH POUCH LIF (1) IMPERVIOUS STOCKINETTE (3) STRIPS TAPE 24" X 4" (1) DRAPE U WITH TAPE SPLIT (2) TOWELS ABSORBENT 15" X 20" LIF (1) GOWN IMPERVIOUS REINFORCED X-LARGE SMS (1) GOW SURG. REINFORCED LARGE TOWEL/WRAP (1) TABLE COVER REINFORCED 50" X 90" LIF (1) MAYO STAND COVER REINFORCED LIF (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL (1) TUBE SUCTION CONNECT. }4" X 12' LIF (1) SURGICAL BLADE #11 CARBON STEEL (1 ELASTIC BANDAGE 6" X 5 YRD. L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1298, 15 lots: 112041185 112062555 112072865 113015632 113026067 113026165 113026272 113036748 113047122 113057832 113078568 113089184 113109720 140111149 140211639 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices NEURO SPINE PACK - (1) BAG SUTURE FLORAL (1) COVER TABLE 44" X 90" (4) ABSORBENT TOWELS 15" X 20" UF (1) LAPAROTOMY T DRAPE 102" X 78" X 121" STD SMS (4) DRAPE UTILITY WITH TAPE LIF (3) GOWN IMP. EXTRA REINFORCED LARGE TIWRAP (1) DURAPREP SURGICAL SOLUTION 26mL UF (1) INCISION DRAPE 23" x 17" (1) INSTRUMENT POUCH (2) CAUTERY TIP POLISHER LIF (1) CAUTERY PENCIL HANDSWITCHING LIF (2) CONTAINER SPECIMEN 4oz WITH LID & LABEL (1) YANKAUER SUCT. TUBE WITHOUT VENT LIF (2) LITE GLOVES LIF (1) TUBE SUCTION CONNECT. Y.." X 12' LIF (1) SKIN MARKER WITH RULER (1) INCISE DRAPE ANTIMICROBIAL 23"x17" LIF (1) Pk SURGICAL STRIP W'X 6" (5) LAP SPONGES PRE-WASH 18" X 18" XRD L/F (20) GAUZE SPONGE 4"X 4" 16 PLY XRD LIF (1) SCALPEL WITH HANDLE #10 STAINLESS STEEL (5) DRAPE % ECONOMY 53" X 77" LIF (2) TABLE COVER HD 77" X 110" L!F (1) MAYO TRAY LARGE (1) UTILITY BOWL 16 oz LIF (2) NEEDLE & BLADE COUNTER 10c MAG/CLEAR L/F (2) SYRINGE 10cc WITHOUT NEEDLE LIL UF (1) SCALPEL WITH HANDLE #15 STAINLESS STEEL (1) J VAC RESERVOIR 300 mL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1300, 20 lots: 109050993 112051747 112093868 112104141 112124943 113015633 113025937 113036226 113046883 113047325 113057419 113078249 113099270 113109990 131110171 140111097 140211640 140312065 140412551 140513082 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices PEDIATRIC LAP PACK - ( I) SHEET MINOR LAP 102" X 121" X 78" ( I) MAYO STAND COVER REINFORCED LIF ( I) TABLE COVER REINFORCED 50" X 90" LIF (2) DRAPE SHEET 41 " X 58" SMS (2) TOWELS ABSORBENT 15" x 20" LIF (I ) BAG SUTURE FLORAL LIF (4) DRAPE UTILITY WITH TAPE L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1383, 32 lots: 109010046 109020262 109030545 109061169 109061419 109071711 109071724 109091995 109102264 109122744 110010037 110020306 110081959 110092383 110123086 111010040 111030570 111051156 111061493 111061849 111071888 111082185 112051750 112093869 112104143 112114938 113067949 113068039 113099302 113109721 140412844 140613591 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices OPEN HEART TRAY - - PACK A ( 1) CV SPLIT DRAPE W/ CLEAR AN EST SCREEN STD SMS LIF (5) DRAPE % ECONOMY 53" X 77" LIF ( 1) MAYO STAND COVER REINFORCED LIF (7) DRAPE UTILITY WITH TAPE L/F (8) HUCK CLOTH TOWELS WHITE L/F (20) HUCK CLOTH TOWELS BLUE LIF (1) MAYO TRAY LARGE LIF (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE LIF (6) 3/4 SHEET DRAPE REINFORCED LIF (2) STOCKINETTE 9" X 48" LIF (1) SPLIT SHEET BILATERAL 84" X 80" LIF (3) DRAPE SHEET 41" X 58" SMS LIF (4) Pr. GLOVES SURGEON #7 BIOGEL OPEN HEART TRAY - HOSPITAL DAMAS - PACK B- (1) PLASTIC RULER 12" LONG (2) SYRINGE 60ML WITHOUT NEEDLE LISLIP L/F (1) Pk. PEANUT SPONGE DISSECTOR ST. (2) UTILITY BOWL 32 oz. LIF (1) SKIN MARKER WITH RULER LIF (2) UTILITY BOWL 16 oz. UF (3) BULB SYRINGE 60cc UF (1) MAYO TRAY SMALL L/F (2) YANKAUER SUCT. TUBE WITHOUT VENT UF (1) TRAY ORGANIZER FULL DEEP LIF (5) SAPHENOUS VEIN CANNULA LIF (40) LAP SPONGES PRE-WASH XRD UF (2) ELASTIC BANDAGE 6" X 5 yds. UF (2) SUTURE BAG FLORAL (2) NEEDLE & BLADE COUNTER 40c FOAM/MAG UF (1) BLADE SHARP ALL ARROUND 69 (1) SURGICAL BLADE# 11 CARBON STEEL (4) LITE GLOVES UF (2) SURGICAL BLADE# 15 CARBON STEEL (1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL (1) SYRINGE 1 cc TUBER 25G X 5/8 S/TIP LIF (2) POUCH INSTRUMENT (2) SURGICAL BLADE# 10 CARBON STEEL (30) GAUZE SPONGES 4" X 4" 16 PLY XRD UF (2) CAUTERY PENCIL ROCKER SWITCH LIF (2) POLISHER CAUTERY TIP UF (1) LABEL SET, HEPARINE,SALINE (2) ELASTIC BANDAGE 4" X 5 yds. LIF (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE UF (1) NEEDLE HYPODERMIC 18G X 1% LIF (2) COTION GLOVE HEAVY DUTY (1) AORTIC MONITORING PRESS SET 5.0 (1) CONNECTOR Y 3/8" X 3/8" X 3/8" LIF (2) NEEDLE HYPODERMIC 22G X 1 % LIF (1) BLADE 6.1 X 32.3 X 1.0MM (1) SQUARE TWO PIECE 500cc GRADUATE (2) CONNECTOR REDUCER (1) NEEDLE BLADE/KNIFE 3.0MM EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1393, 6 lots: 112041420 113078354 113109651 140211586 140312499 140613718 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices VEIN PACK - (1) GOWN STANDARD LARGE SMS VELCRO/NECK (3) LAP. SPONGES PREWASH XRD LIF (1) EXTREMITY SHEET ABS LIF (1) WRAPPER 36" X 36" (1) IMP. STOCKINETTE 14" X 48" LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1401, 3 lots: 109050994 110020540 110081960 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices PLASTIC SURGERY PACK - LABEL SAMPLE CONTENTS: (2) GOWN LGE SMS NON REINF T/WRAP L/F (1) MAYO STAND COVER REINF. LIF (10) GAUZE SPONGE 4" X 4" 16 PLY LIF (1) TABLE COVER 44" X 90" (1) DRAPE SHEET 70" X 100" LIF (2) SURGICAL BLADE #15 S/STEEL (1) DRAPE HEAD WIT APE 44" X 26" LIF (30) COTION TIP APPLIC 6" WOOD LIF (1) PVP PAINT 8" STICK SPONGE (1) NEEDLE & BLADE COUNTER 20C FOAM I MAG L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1402, 14 lots: 112041394 112051751 112072866 112093870 112124944 113036451 113046933 113057834 113088696 113088831 131110172 140111093 140412599 140513083 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices UMBILICAL VESSEL CATHETER KIT - CUSTOMED- (1) PAPER TAPE MEASURE DISP. 24" (1) FENESTRATED DRAPE 18" x 26" LIF (1) NEEDLE HOLDER BAUMGARTNER 5" (2) HALSTED MOSQUITO CVD 5" SERRAT (1) ADSON FORCEP TISS. Wff (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF (6) GAUZE SPONGE 2" X 2" 8PL Y (6) GAUZE 4" X 4" 16PL Y (1) SYRINGE 1 cc TB SffiP (1) IRIS FORCEP SERR Y. CVD 4" WITH PROTECTOR TIP (1) NEEDLE WITH FILTER 18 X 1 Y. BLUNTffiP (1) SUTURE 3-0 BLK MONOFIL (1) TRAY ORGANIZER FULL DEEP (1) WRAPPER 30" X 30" L/F (1) PVP TRIPLE IODOPHOR SWABSTICK (1) TONGUE DEPRESSOR 6" WOOD (1) IRIS SCISSOR STRAIGHT 4 Y. W/PROTECTOR TIP (1) SCALPEL WITH HANDLE #11 (1) MOSQUITO FORCEP STRAIGHT 5" (2) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK LIF (2) 3 PLY POLY TOWEL (1) UMBILICAL TAPE (1 ) PROBE GRONED & DISNEETNS 6" 2ML (1) EYE DRESSING EXT FINE POINT FULL (2) NEEDLE WITH FILTER 18 X 1 Y. NOKOR PO (1) PLASTIC TRAY 2/COMPARTMENT (1) HALF TRAY (1) STOPCOCK 3 WAY LUER SLIP EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1408, 7 lots: 113015546 113057835 140211780 140412600 140513084 113047152 112051753 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices REYITO UROLOGY PACK - (2) GOWN IMP. REINFORCED X-LARGE SMS (2) TOWELS ABSORBENT UF ( I) URINARY DRAIN. BAG 2000ML ANTI-REFLUX UF ( I) SYRINGE 30cc W/0 NDL. LUER LOCK UF ( I) BAG SUTURE (I) TABLE COVER ( I} TUBE SUCTION CONNECT. W' X 12' UF (10) GAUZE SPONGES 4" X 4" 16PLY ( I) EMESIS BASIN (I) DRAPE LASER CAMERA W/E ( I} UTILITY BOWL32oz (I) BOWL PLASTIC 80oz WITH LID ( I) SYRINGE IOcc W/0 NDL. LUER LOCK UF (I} SYRINGE IOcc PREFILLED WITH GEL (5) CONTAINER SPECIMEN 4oz W/LID & LABEL (I) GOWN SURG. REINFORCEDT/WRAP X-LARGE ( I} TUR Y SET, 2LEAD UF ( I} DRAPE LITHO 11 0" X 63" WI POUCH WILEGGING ( I} ROUND WASH BASIN 6QT. EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1460, 29 lots: 109050945 111123344 112010046 112020337 112041074 112051759 112062229 112062272 112083031 112083391 112093722 112114564 112124948 113015428 113036592 113047001 113047147 113057686 113067887 113078253 113078702 113089190 131110174 131210632 140111081 140211866 140311920 140312391 140513089 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices IMPLANTE DE ORTHOPEDIA - ( I) CAUTERY T IP POLI SHER LIF ( I) BAG SUTURE FLORAL LIF ( I) TUBE SUCTION CONNECT \14'' X 12' LIF ( I) BAG GLASSINE LIF (2) LITE GLOVE LIF (2) TABLE COVER 50" X 90" REINFORCED LIF ( I) MAYO STAND COVER REINFORCED LIF (5) TOWEL ABSORBENT 15" X 20" LIF (4) DRAPE UTILITY WITH TAPE LIF (2) DRAPE SHEET 70" X I 00" LIF (5) LAP SPONGES PRE-WASH 18" X 18" XRD L/F ( I) MAYO TRAY LARGE LIF ( I) DRAPE TOP WITH ADHESIVE LIF ( I) SKIN STAPLE 35 WIDE LIF ( I) BULB SYRINGE 60cc LIF ( I) UTILITY BOWL 16oz L/F (2) UTILITY BOWL 32oz L/F ( I) INCISION DRAPE 23" X I 7" L/F (I) SKIN MARKER WITH RULER LIF ( I) U-DRAPE 54" X 72" W/TAPE SPLIT 6" X 2 1" LIF (2) ABDOMINAL PAD 8" X 7.5" L/F ( I) YANKAUER SUCTION TUBE W/0 VENT L/F (I) DURAPREP SURGICAL SOLUTION 26ML LIF ( I) SURGICAL BLADE # 10 STAINLESS STEEL (I) SPLIT SHEET W/ADH 108" X 77"" STD SMS LIF ( I) IMP. STOCKINETTE LIF (I) *Pr. SURGEON NEUTRALON GLOVE #7 ~ LATEX ( I) *Pr. SURGEON NEUTRALON GLOVE #8 LATEX (I) *Pr. SURGEON NEUTRALON GLOVE #8 ~ LATEX (I) SURGEON GOWN REINF. T/WRAP X-LARGE LIF (2) IMP. GOWN REINFORCED X-LARGE SMS LIF (I) PENCIL CAUTERY ROCKER SWITCH LIF (I) SURGICAL BLADE #20 STAINLESS STEEL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1476, 12 lots: 112030618 112072885 112104097 112114378 112114555 112124949 113015689 113047329 113078255 113088832 113089191 121104357 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices E..N.T. PACK - (5) SPONGE TONSIL 7/8 XRD (1) TABLE COVER REINFORCED 50" X 90" LIF (1) MAYO STAND COVER REINFORCED L/F (1) TUBE SUCTION CONNECT %" X 12' L/F (1) CAUTERY TIP POLISHER LIF (1) SUTURE BAG FLORAL (2) CONTAINER SPECIMEN 4oz WITH LID & LABEL (1) CAUTERY PENCIL HAND SWITCHING (2) ABSORBENT TOWELS 15" X 20" L/F (1) DRAPE SHEET 41 " X 58" SMS L/F (1) EAR/ULCER SYRINGE 2oz LIF (2) MEDICINE CUP 2oz (1 0) GAUZE SPONGE 4" X 4" 16PL Y (1) *Pr. SURGICAL GLOVES #7% POWDER (1) *Pr. SURGICAL GLOVES #7 POWDER (9) LABEL FOR SKIN MARKER EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1482, 39 lots: 110102428 110112608 110123088 111010049 111020265 111030581 111040888 111051317 111061497 111071865 111082190 111092354 111102683 111113009 111123347 112010050 112020371 112030620 112041188 112051766 112062419 112083396 112093898 112124950 112125282 113025940 113036669 113047197 113067888 113068256 113078256 113109732 131210747 140111083 140211641 140312070 140312453 140513090 140613609 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices ANGIOGRAPHY PACK - (1) LINE H.P. 1200 PSI 48" M/F (1) ANG. FEMORAL DRAPE WITH POUCH UF (1) PLATFORM TRAY LARGE (3) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (2) BAG BAND RUBBAN & TAPE UF (2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (5) ABSORBENT TOWELS 15" X 20" LIF (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK LIF (1) SURGICAL DURAPREP SOLUTION 6ML LIF (1) SAFETY SCALPEL #11 STAINLESS STEEL (2) GOWN STANDARD SMS LARGE VELCRO NECK (1) MANIFOLD WITH CONTROL SYRINGE (1) NEEDLE 18G X 2% AMC/4 (2) UTILITY BOWL 16oz UF (2) CLOTH HUCK TOWEL BLUE (2) NEEDLE HYPODERMIC 21 G X 1 ~ LIF (2) MEDICINE CUP 2oz LIF (30) GAUZE SPONGE 4" X 4" 16PL Y (1) NEEDLE HYPODEMIC 18G X 1 ~ (4) TOWEL CLAMP (2) SYRINGE 3cc WITHOUT NEEEDLE LUER LOCK LIF (1) HALSTED MOSQUITO CVD 5" SERRAT (2) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK L/F (2) NEEDLE HYPODERMIC 22G X 1 EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1488, 16 lots: 111123348 112010051 112020372 112030619 112041075 112072775 112104146 112124636 112124951 113025839 113026046 113036412 113078257 131210748 140211642 140412601 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices D & C LAPAROSCOPY PACK - (1) TUBING INSUFFLATION OPEN TIP WITHOUT VENT (1) MAYO STAND COVER REINFORCED UF (4) DRAPE UTILITY UF (1) TRAY MAYO SMALL LIF (1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL (1) SUTURE BAG FLORAL LIF (1) TUBE SUCTION CONNECT X" X 12' LIF (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (2) LEGGINGS WITH 7" CUFF 30" X 42" LIF (1) UTILITY BOWL 32oz. UF (1) *FOLEY CATHETER 5CC/2 WAY 16FR SILICONE COATED LATEX (2) DRESSING NON ADH TELFA 4 X 3 ST. UF (1) JELLY LUBRICATING FIVE GRAM (1) TABLE COVER REINFORCED 50" X 90" LIF (1) *Pk. STERI STRIP LAP SET LATEX (1) COVER CAMERA W/ELAST UF (2) GOWN LARGE SMS IMPERVIOUS REINFORCED UF (4) TOWELS ABSORBENT 15" X 20" UF (1) DRAPE LAP. PERINEAL WITH POUCH 102" X 97" SOFT SMS UF (2) LIGHT SHIELD (1) DRESSING TEGADERM 4" X 4 %" LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD UF (1) GOWN SURG. REINFORCED X-LARGE TOWEL/WRAP (1) SCALPEL WEIGHTED SAFETY #11 (1) BAG ZIP LOCK (1) Pk. STRIP STERI CLOSURE W' X 4" LIF (1) TIME OUT BEACON NON WOVEN ST. UF (1) BANDAGE GAUZE STRETCH 4" (1) NEEDLE ULTRA VERES 120MM UF (2) COUNTER NDUBLADE, 10C MAG/CLEAR UF (1) SKIN MARKER INK WITH 8 LABEL !TIME OUT/RULER L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1496, 22 lots: 112041078 112051677 112062422 112114953 113015550 113025817 113026047 113036320 113036750 113057690 113067952 113088734 113099274 113109735 131110178 131210749 140111077 140211644 140311921 140412602 140513092 140513391 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices CIRUGIA CARDIOVASCULAR - CASE CART - (1) CIRUGIA CARDIOVASCULAR (PREPARACION) (1) CIRUGIA CARDIOVASCULAR (ENFERMERA CIRCULANTE) (1) CIRUGIA CARDIOVASCULAR (INDUCCION) (1) OPEN HEART TRAY EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1500, 7 lots: 110061567 131211069 140211907 140312371 140412630 140412871 140613717 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices LAPAROSCOPY CHOLECYSTECTOMY PACK- (1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD UF (2) ABSORBENT TOWELS 15" X 20" UF (1) MAYO STAND COVER REINFORCED UF (4) BANDAGE ADHESIVE W' x 3" L I F (4) DRAPE UTILITY WIT APE UF (1) TUBE SUCTION CONNECT. Y..'' X 12' UF (1) INSUFLAT TUBING SET W/0 RING ADAPTOR UF (1) LAPAROSCOPY ABO. DRAPE W/Pouch UF (1) IMP. GOWN REINFORCED XLge. SMS (2) SYRINGE 60ML W/0 NDL. LILOCK UF (1) SYRNGE 20 cc W/0 NDL ULOCK UF (1) SURGICAL BLADE #15 C/STEEL (1) DRAPE LASER CAMERA W/EL (2) COVER HANDLE LITE LOCK (1) TABLE COVER Reinforced 50" x 90" UF (3) DRAPE SHEET 41 " x 58" SMS (1) SURG. GOWN REINFORCED T/Wrap Lge. EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1515, 2 lots: 110061486 111030825 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices UROLOGY PACK- (10) GAUZE SPONGE 4" X 4" 16PLY (1) TUBE SUCTION CONNECT Y." X12' (1) SYRINGE 30cc WITHOUT NEEDLE ULOCK (1) BASIN RING (1) TUR Y SET, 2 LEAD, ST. (1) BAG SUTURE FLORAL (1) GOWN SURG. REINF. XL EXTRA LONG LEVEL IV (2) TOWEL CLAMP (1) DRAPE LITHOTOMY W/LEGGIN I POUCH UF 11 0" x 63" (2) SHEET DRAPE 41 " X 58" SMS (1) COVER TABLE REINF 50" X 90" (1) BAG URINARY DRAINAGE 2000ML ANTI-REFLUX (3) TOWELS ABSORBENT 15" X 20" (1) GOWN IMP. SMS EXTRA REINF. XL T/WRAP LEVEL IV (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL (1) TIME OUT BEACON NON WOVEN ST. EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1521, 27 lots: 111102904 112041376 112041452 112062286 112104149 112114602 112124957 113015430 113015690 113025942 113026048 113036739 113046934 113047002 113047332 113057836 113078260 113088737 113088931 113089193 131110180 131110598 131210962 140211645 140211922 140412884 140513346 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices DRESSING CHANGE - CUSTOMED- (2) GLOVE MED. FREETOUCH VYNIL POWDER FREE ( I) DRESSING TEGADERM 3 Y2 X 4 Y2 ( I) MASK PROCEDURAL YELLOW 80MM HG L/F (4) GAUZE 4" X 4" 4PLY ( I) ALCOHOL PREP PAD MED ( I) CI-ILORASCRUB SWABSTICK 1.6 ( I) LABELCAUTION ( I) DRAPE NON FENESTR. 18" X 26" UF ( I) TAPE TRANSPORE :Y. X 18 LIF ( I) WRAPPER 20" X 20'' EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1538, 12 lots: 113078261 113088739 113089084 113109657 131110181 131210634 140111156 140211646 140312073 140412553 140412914 140613614 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices UNIVERSAL PACK - (1) TRAY ORGANIZER FULL DEEP (1) ANESTHESIA SPINAL NEEDLE 22G X 3 ~ UF (1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK UF (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK UF (1) NEEDLE HYPODERMIC 20G X 1 ~ UF (2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS AAMI Ill (1) SHEET SPLIT WITH ADHESIVE 108" X 77" STD SMS LIF (1) SHEET% 57" X 63" REINFORCED SMS LIF (2) TOWELS ABSORBENT 15" X 20" LIF (4) DRAPE UTILITY LIF (1 0) GAUZE SPONGES 4" X 4" 12PL Y LIF (4) CLOTH HUCK TOWELS BLUE LIF (1) TABLE COVER REINFORCED 50" X 90" UF (1) SCALPEL WITH HANDLE #11 (1) DENTURE CUP WITH LID (1) TRAY 2 COMPARTMENT (2) ABSORBENT TIP APPLICATOR (1) IMPERVIOUS STOCKINETIE 14" X 48" LIF (1) TAPE TRANSPORE 1" X 36" (1) DIISP NEEDLE 30 X ~ (1) PROBE DRAPE 6" X 96 WITH GEL (1) ARTERIAL NEEDLE 18 X 2 % (1) CATHETER INTRODUCER 7FR (1) NEEDLE & BLADE COUNTER 10c MAG/CLEAR L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1587, 36 lots: 102030623 110082155 110082298 110102430 110112610 110122922 111010202 111020362 111030586 111040993 111051366 111061501 111071771 111082193 111092502 111102687 111113016 111123356 112010065 112020382 112041190 112051845 112062430 112072709 112083158 112083400 113015504 113025773 113036453 113036751 113067890 113089195 113099383 131110184 140111159 140312077 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices RETINA PACK - (1) TABLE COVER REINFORCED 44" X 78" LIF (50) COTTON TIP APPLICATOR 6" WOOD LIF (2) GOWN IMPERVIOUS EXTRA REINFORCED LARGE (2) MEDECINE CUP 2oz LIF (5) TOWELS ABSORBENT 15" X 20" LIF ( 1) UNIVERSAL EYE SHIELD (1) EYE DRAPE (1) BIPOLAR CABLE DISPOSABLE ( 1) OPHTALMIC BIPOLAR PENCIL (10) GAUZE SPONGE 4" X 4" 16PLY (2) EYE PAD 2 1/8 X 2 5/8 ST. ( 1) MAYO STAND COVER REINFORCED LIF ( 1) KNIFE 15 5.0 CONTROLLED DEPTH. (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG LIF (1) SURGICAL BLADE #15 STAINLESS STEEL (3) SYRINGE 1CC TUBER. 25G X 5/8 SLIP TIP L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1611, 10 lots: 111123361 112030624 112051849 112072779 112114640 112124965 113078268 113088833 140412455 140513000 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices LAPAROSCOPY CHOLE PACK - (1) DRAPE LASER CAMERA WITH ELASTIC 6" X 96" LIF (2) SHEET DRAPE 42" X 57" SMS (1) TUBE SUCTION CONNECT. %" X12' LIF (1) SURGICAL BLADE #10 STAINLESS STEEL (1) TABLE COVER REINFORCED 44" X 78" LIF (1) DRAPE LAPAROSC. ABD 102" X 122" X 78" WITH POUCH (5) LAP SPONGES PREWASH XRD L/F (1) NEEDLE HYPODERMIC 18G X 1 %" (1) MAYO STAND COVER REINFORCED LIF (1) UTILITY BOWL 32oz. L/F (1) TUBING INSUFFLATION SET W/0 RING ADAPTOR LIF (4) TOWEL ABSORBENT 15" X 20" L/F (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL (1) CLOTH HUCK TOWEL BLUE L/F (1) PVP PAINT 8" STICK SPONGE (4) DRAPE UTILITY WITH TAPE LIF (2) UTILITY BOWL 16oz LIF (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) PVP SCRUB 8" STICK SPONGES (1) CLIPS LIGATING TIT M/L (L T 300) (4) TEGADERM 2 3/8 X 2% L/F (4) GOWN SURG. REINFORCED LARGE TOWEL/WRAP EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1688, 16 lots: 112114380 112114643 113036740 113047004 113057426 113068154 113088751 113099276 131110193 140211464 140211704 140311926 140312434 140412555 140513103 140513462 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices CESAREAN PACK - (1) BABY BLANKET IMP. 30" X 30" POLY ABS. (1) NEEDLE & BLADE COUNTER 60c FOAM/STRIP MAG/STRIP LIF (1) DRESSING ISLAND 4" x 10" (1) CESAREAN DRAPE 71" x 125" LIF (2) GOWN SURG REINFORCED LARGE TOWEL/WRAP (10) LAP SPONGES PREWASH XRD LIF (1) BABY BEANNIES (1) SCALPEL #10 WITH HANDLE STAINLESS STEEL (1) DRAPE SHEET 42" X 57" SMS (1) EAR ULCER SYRINGE 2oz. UF (1) RECEIVING BLANKET 100% COTTON (1) SCALPEL #20 WITH HANDLE (1) DURAPREP SURGICAL SOLUTION 26ml UF (2) ABSORBENT TOWEL 15" X 20" L.F (2) LITE GLOVES UF (1) BOWL WITH LID PLASTIC 80oz. (1) TABLE COVER REINFORCED 44" x 78" LIF (1) UTILITY BOWL 32oz (2) PAD OBSTETRICAL X-LARGE ST. (1) WRAPPER 30" X 30" LIF (1) MAYO STAND COVER REINFORCED LIF (1) TUBE SUCTION CONNECT Y." X 12' UF (1) MUCUSTRAP 20cc 1 OFR (1) YANKAUER SUCTION TUBE WITHOUT VENT UF (1) UMBILICAL CORD CLAMP EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1689, 20 lots: 111113026 111123373 112051861 112083402 112114645 113015432 113036419 113036729 113047214 113057427 113068155 113088752 113099277 131110194 131210755 140111165 140211884 140312435 140513104 140513464 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices PERY GYN PACK- (1) DRAPE UTILITY WITH TAPE (1) DRAPE UNDERBUTIOCK WITH POUCH (1) TOWELS ABSORBENT 15" x 20" UF (2) LEGGINS W/7'' CUFF 30" X 42" (1 ) TABLE COVER REINFORCED 50" X 90" UF (1) DRAPE ABDOMINAL WITH TAPE UF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1716, 53 lots: 109061244 109071562 109081820 109092024 109102291 109122762 110020332 110040902 110051214 110061438 110071671 110081969 110082177 110112616 110123093 111010064 111020274 111030598 111041097 111051278 111061509 111071907 111082062 111092362 111102697 111123377 112010084 112020402 112030640 112041197 112051869 112062445 112072783 112083403 112093912 112114382 112125030 113015433 113025947 113036671 113036754 113047005 113057396 113057862 113088757 113089198 113109747 131110329 131210758 140111169 140211650 140312082 140412456 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices O.B. PACK - (I) TABLE COVER REINFORCED 50" X 90" LIF (I) DRAPE UNDERBUTTOCK WITH POUCH 44" X 35" (2) LEGGINS W/7'' CUFF 30" X 42" (1) GOWN LARGE SMS IMPERVIOUS REINFORCED (3) TOWELS ABSORBENT 15" X 20" LIF (I) PAD OBSTETRICAL X-LARGE ST. (I) PACKING VAG JNAL 4" X 36" 8PL Y XRD (10) GAUZE SPONGES 4" X 4" 12PLY XRD (I) UMBILICAL CORD CLAMP (1) BABY BLANKET PRINTED (2) EAR/ULCER SYRINGE 2oz. LIF (I) COVER SET UP 42" X 75" CLEARPOLY (1) DRAPE ABDOMINAL WITH TAPE L/F (1) BOWL WITH LID PLASTICS 80oz. L/F (1) SHEET DRAPE 41" X 58" SMS LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1717, 49 lots: 109102292 109112479 109122763 110030824 110040903 110061439 110071672 110081970 110082178 110092389 110112617 110122925 111010065 111020275 111030600 111051279 111061510 111071778 111082063 111092363 111102698 111113030 111123378 112010085 112020403 112030641 112041198 112051872 112062446 112072784 112083404 112093911 112104294 112114647 112125031 113036755 113057397 113067893 113078272 113088758 113089199 113099389 131110197 131210759 140111170 140312083 140412457 140513109 140613626 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices CESAREAN PACK - (1) MAYO STAND COVER REINFORCED LIF (5) TOWELS ABSORBENT LIF (1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED L/F (3) DRAPE SHEET 41" X 58" SMS LIF (1) BABY BLANKET PRINTED LIF (1) BOWL PLASTIC 80oz WITH LID (1) TUBE SUCTION CONNECT.%" X 12' LIF (15) LAP SPONGES PREWASH XRD LIF (1) EAR ULCER SYRINGE 2oz. LIF (1) PAD OBSTETRICAL X-LARGE ST. L/F (1) YANKAUER SUCTION TUBE WITHOUT VENT L/F (1) SYRINGE 20cc SITIP LIF (1) FEEDING TUBE 8FR. 15" LONG (1) BABY BEANNIES LIF (1) DRESSING ISLAND 4" X 14" (1) DRAPE C-SECTION WITH POUCH 102" X 121" X 78" (1) GOWN SURG. REINFORCED XLGE TOWEL/WRAP (1) TABLE COVER REINFORCED 50" X 90" L/F (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF (1) SUTURE BAG FLORAL LIF (1) UMBILICAL CORD CLAMP (1) BLADE SURGICAL #20 CARBON STEEL (1) WRAPPER 24" X 24" L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1719, 23 lots: 111082259 111092364 111123379 112010086 112020404 112041199 112051873 112062447 112125292 113015635 113026050 113036756 113057398 113067894 113078273 113088759 113099390 113109748 131210760 140111171 140211792 140312084 140412458 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices MINOR LAPAROTOMY PACK - (1) TABLE COVER 50" X 90" REINFORCED LIF (1) GOWN SURG. X-LARGE REINFORCED TOWEL/WRAP (1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED LIF (3) TOWELS ABSORBENT 15" X 20" LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (2) COUNTER NEEDLE & BLADE 10C MAG/CLEAR LIF (5) LAP SPONGE PREWASH XRD L/F (4) DRAPE UTILITY WITH TAPE LIF (2) LITES GLOVE LIF (1) TUBE SUCTION CONNECT. ~" X 12' LIF (1) COVER MAYO STAND REINFORCED LIF (1) UTILITY BOWL 32oz (2) UTILITY BOWL 16oz (1) SPECIMEN CONTAINER 4oz WITH LID & LABEL (1) CAUTERY TIP POLISHER LIF (1) BLADE SURGICAL #10 CARBON STEEL (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) BAG SUTURE FLORAL (1) DRAPE SHEET MEDIUM 41" X 69" LIF (1) DRAPE LAP WITH POUCH SMS STD L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1735, 50 lots: 110102434 110112619 110112893 111010068 111020366 111030604 111040842 111051280 111061589 111071909 111082065 111082258 111092365 111102646 111102700 111112936 111112963 111123380 112010087 112010246 112020405 112030642 112041200 112051874 112062448 112072785 112083406 112114610 112125032 112125313 113015434 113025948 113026232 113036783 113057399 113057692 113057813 113068157 113078569 113089200 113099567 131110069 131110403 131110580 131210964 140111412 140211885 140312330 140412886 140513347 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices UROLOGY PACK - (4) ABSORBENT TOWELS UF (2) GOWN SURGICAL POLY-REINF. BREATHABLE XL LEVEL IV (1) SYRINGE 30cc WITHOUT NDL LUER LOCK L/F (1) TUR Y SET, 81 "2 .1M REGULAR CLAM (1) TABLE COVER 44" x 90" (1) DRAPE LITHO 11 0" X 63" WITH POUCH /LEGGING FEN (1) TUBE SUCTION CONNECT. Y." X 12' LIF (1) WASH BASIN ROUND 6QT (1 0) GAUZE SPONGE 4" X 4" 16PL Y LIF (1) BAG URINARY DRAINAGE 2000ml ANTI-REFLUX LIF (1) DRAPE LASER CAMERA W/EL UF (1) SYRINGE 1 Occ W/0 NDL LUER LOCK UF (1 ) UTILITY BOWL 32oz. (1) GEL SYRINGE 10cc PREFILLED (5) SPECIMEN CONTAINER 4oz. W/LID & LABEL L/F (1) WRAPPER 20" X 20" L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1738, 20 lots: 111030607 111051369 111061590 111071991 111082066 111102866 111113031 111123419 112010088 112020406 112030643 112041201 112051875 112083056 112093914 112114648 113088760 113089083 140211651 140312085 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices UROLOGY PACK - (3) TOWELS ABSORBENT 15" X 20" UF (1) WASH BASIN ROUND 6QT. (1) SYRINGE 30cc W/O NEEDLE LUER LOCK UFN (1) BAG URINARY DRAINGAGE 2000ml ANTI-REFLUX (1) BAG SUTURE FLORAL (1) GOWN SURG. REINFORCED X-LARGE T/VIJRAP (1) TABLE COVER 44" X 90" UF (2) DRAPE SHEET 42" X 55" SMS UF (1) TUBE SUCTION CONNECT. Y." X 12' UF (1) MAYO STAND COVER REINFORCED UF (10) GAUZE SPONGE 4" X 4" 16PLY (1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED (1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL (1) TUR Y SET TWO LEAD ST. UF (1) DRAPE LITHO 110" X 63" SMS WITH LEGGINS EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1742, 14 lots: 111113032 111123382 112010089 112020407 112041202 112051876 112083407 112093915 112125157 113015435 113036757 140412562 140513111 140513393 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices OPHTALMIC PACK - (1) GOWN LGE SMS NON REINF TIWRAP (1) IODINE POVIDONE 1oz. (2) TOWEL ABSORBENT 15" x 20" UF (1) SYRINGE 3cc W/NEEDLE 21 G X 1 Y. UF (6) COTION TIP APPLICATOR 6" WOOD (1) TABLE COVER REINFORCED 50" X 90" UF (1) PAD EYE 2 1/8 X 2 5/8 (1) CYSTOTOMO IRRIG. PEARCE 25G X 5/8 (1) SHIELD EYE UNIVERSAL (1) Pr. GLOVES SURG.# 7% LATEX (10) SPONGE EYE SPEAR MICRO (1) SYRINGE 1cc TUBER. 25G X 5/8 SITIP UF (10) GAUZE SPONGES 4" X 4" 12PL Y (1) Pr. GLOVES SURG. 8 POWDER LATEX (1) MAYO STAND COVER REINFORCED UF (1) BLADE 15D WITH HANDLE (STABKNIFE) (1) EYE DRAPE (1) GOWN LARGE STANDARD SMS (1) TRAY 3/COMPART (1) BAG ZIP LOCK (1) ANGLED FULL HANDLE (1 ) Pr. GLOVES SURGICAL# 6% LATEX EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1780, 25 lots: 112010094 112020415 112041205 112051885 112072786 112083376 112083453 112104301 112114612 112125037 113015436 113036758 113057839 113068042 113078279 113088764 113099281 113109757 131110203 131110602 140111178 140211654 140312436 140513114 140513454 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices LAPAROSCOPY PREMIUM PACK - (1) TABLE COVER REINFORCED 50" x 90" UF (4) TOWEL ABSORBENT 15" x 20" UF (10) GAUZE SPONGE 4" X 4" 16PLY XRD UF (1) DRAPE LASER CAMERA W/EL UF (1) TROCAR ENDO.XCEL DILATING TIP (KSLT) (1) APPLIER CLIP 5MM (3) GOWN XLGE SMS IMPERV. REINFORCED (1) BLADE SURGICAL #11 S/STEEL (1) NEEDLE PNEUMO INSUFLAT. 150MM UL UF (1) MAYO STAND COVER REINFORCED UF (1) DRAPE LAPAROSCOPY ABDOM. W/POUCH (4) DRAPE UTILITY WITH TAPE UF (1) TUBING INSUFFLATION SET W/0 RING ADAPTOR U/F (1) TROCAR DILATING XCEL 5MM x 100 (D5LT) (1) TROCAR ENDO.XCEL DILATING TIP 11MM (1) SUTURE BAG FLORAL UF (1) CLOSURE SKIN W' X 4" STERI STRIP LF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1803, 7 lots: 112114857 112125169 113026230 113036759 140312276 140412556 140513115 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices ARTHROSCOPY PACK- (1) TABLE COVER REINFORCED 50" X 90" (1) PRE PAD WITH CUFF (2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill (1) GOWN IMPERV. EXTRA REINFORCED LGE TNVRAP (1) MAYO STAND COVER REINFORCED (1) TUBE SUCTION CONNECT. X" X 12' (1) STOCKINETTE IMPERVIOUS 14" X 48" (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6" x 21 " (1) SHEET ARTRHOSCOPY "T" W/POUCH STD SMS (1) SUTURE BAG FLORAL (3) ABSORBENT TOWEL 15" X 20" EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1832, 39 lots: 109122842 110010063 110020346 110030645 110051220 110071773 110082195 110092199 110102436 110112622 110122927 111010075 111030627 111041079 111051370 111071782 111082071 111092368 111102709 111113047 111123182 112020420 112030819 112041405 112051890 112072788 112083304 112083409 113026166 113036456 113036733 113047115 113047200 113078282 113088768 113099486 113099587 131010209 140111184 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices HIP ORTHOPEDIA PACK - (1) BLADE SURGICAL #15 STAINLES /STEEL (1) GOWN XL SMS IMPERVIOUS REINFORCED MMI Ill LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) MAYO STAND COVER REINFORCED LIF (4) DRAPE UTILITY WIT APE LIF (4) TOWEL ABSORBENT 15" X 20" LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (2) DRAPE SHEET 41" X 58" SMS LIF (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG LIF (10) GAUZE 4" X 4" 4PLY (2) UTILITY BOWL 16oz LIF (1) CAUTERY TIP POLISHER LIF (1) SUTURE BAG FLORAL (1) BLADE SURGICAL#10 STAILESS STEEL (1) SURGICAL DURAPREP SOLUTION 26m! LIF (1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL (10)GAUZE SPONGE 4" X 4" 16PLY XRD LIF (5) LAP SPONGE PRE WASH 18" X 18" XRD LIF (1) CAUTERY PENCIL ROCKER SWITCH LIF (1) TUBE SUCTION CONNECT. 3/16" X 12' LIF (1) DRAPE INCISE ANTIMICROBIAL 23" X 33" (2) SHEET DRAPE 70" X 100" LIF (1) DRAPE TOP WITH ADHESIVE 108" X 50" STD SMS LIF (1) SHEET SPLIT WITH ADHESIVE 108" X 77" STD SMS L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1835, 3 lots: 113109763 131210771 140412619 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices PERl GYN PACK - (1) TOWEL NON ABS. W/TAPE L/Free (1) DRAPE UNDERBUTTOCK W/POUCH (2) TOWELS ABSORBENT L/Free (2) LEGGINGS W/7" CUFF (1) DRAPE TOP WI ADHESIVE (1) TABLE COVER REINF. L/Free (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) CATHETER 14FR ROBIN NELAT PVC (2) GOWN LGE SMS IMPERVIOUS REINF. EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1871, 1 lots: 111072025 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices BASIC PACK - (1) TABLE COVER REINF. LIF (1) MAYO STAND COVER REINF. LIF (2) TOWELS ABSORBENT LIF (10) GAUZE SPONGES XRD 4" X 4" 12PLY (2) DRAPE SHEET 41" X 58" SMS (4) DRAPE UTILITY WIT APE L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1880, 1 lots: 109010222 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices LAPAROSCOPY PACK - (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR LIF (1) DRAPE ENDOSCOPY 1 00" X 123W' X 77" WITH TROUGHS (1) MAYO STAND COVER REINFORCED LIF (4) TOWEL ABSORBENT 15" X 20" LIF (4) DRAPE UTILITY WITH TAPE LIF (5) GAUZE SPONGE 2" X 2" 4PL Y (1) CORD LAPAROSCOPY FOOD SWICHING MONOPOLAR (1) SCALPEL WEIGHTED SAFETY #11 (1) SOLUTION SURGICAL DURAPREP 26ml UF (1) TABLE COVER REINFORCED 50" X 90" LIF (2) LITE GLOVE UF (1) SUTURE BAG FLORAL UF (1) NEEDLE & BLADE COUNTER 20c FOAM/MAG LIF (1) UTILITY BOWL 32oz. (2) SHEET DRAPE 42" X 57" SMS (1) DRAPE LASER CAMERA W/EL 6" X 96" LIF (5) TAPE TEGADERM 2 3/8 X 2 o/. UF (5) LAP SPONGE PREWASH 18" X 18" XRD L/F (2) GOWN SURG SMS POLY-REINF BREATHABLE IMPERVIOUS SLEEVE AAMI LEVEL IV CRITICAL ZONE X-LARGE (1) GOWN SURG SMS POLY-REINF BREATHABLE IMPERVIOUS SLEEVE AAMI LEVEL IV CRITICAL ZONE X-LARGE TOWEL/WRAP EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1913, 18 lots: 112030657 112041913 112051896 112062467 112114653 112125043 113026231 113036784 113057438 113078284 113088771 113099399 113109766 131110211 131210772 140311185 140412620 140412878 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices AV FISTULA PACK- (1) DRAPE T LAPAROT 102" X 78" X121 " STD SMS (3) GOWN SURG. REINFORCED X-LARGE EXTRA LONG LEVEL IV (1) DRAPE SHEET 42" X 57" SMS (4) DRAPE UTILITY WITH TAPE LIF (1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF (1) PENCIL CAUTERY HAND SWITCHING LIF (1) TUBE SUCTION CONNECT "Y-1" X 12' LIF (1) FRAZIER WITH CONTROL VENT & OBTUR 10F LIF (2) LITE GLOVE LIF (1) BOWL UTILITY 32oz LIF (2) BOWL UTILITY 16oz LIF (10) LAP SPONGE PREWASH XRD LIF (1) SOLUTION SURGICAL DURAPREP 26ML LIF (3) SYRINGE 60ML WITHOUT NEEDLE LUER LOCK LIF (1) SYRINGE 30CC WITHOUT NEEDLE LUER LOCK UF (1) SYRINGE 5CC WITH NEEDLE 21G X 1% LUER LOCK UF (2) SYRINGE 3CC WITHOUT NEEDLE LUER LOCK UF (1) NEEDLE HYPODERMIC 18G X 1 % (2) COUNTER NEEDLE & BLADE 10C MAG/CLEAR UF (1) COVER MAYO STAND REINFORCED LIF (1) COVER TABLE 44" X 90" (1) MAYO TRAY SMALL (2) ABSORBENT TOWEL 15" X 20" UF (1) BOWL WITH LID PLASTIC 80oz EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1922, 21 lots: 110112626 112010102 112030659 112041213 112051899 112062468 112081922 113025826 113036785 113057439 113078286 113088772 113089202 113109767 131110213 140111080 140111186 140211803 140312097 140312460 140412890 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices OPHTALMIC PACK- (1) TABLE COVER REINF. 44" X 78" UF (1) GOWN SMS XLGE STD UF (2) TOWEL ABSORBENT 15" X 20" LIF (1) SYRINGE 3cc W/0 NDL LILOCK UF (1) MAYO STAND COVER REINF. LIF (1) NEEDLE HYPODERMIC 18G X 1% ST. UF (10) EYE MICRO SPONGE UF (2) LABEL CONTRAST BLUE (1) GOWN LGE STD SMS (1) WIPE INSTRUMENT 1MM (1) EYE DRAPE UF (1) LABEL XYLOCAINE FOR MEDICATION YELLOW (1) IODINE POVIDONE 1oz. (1) EYE SHIELD UNIVERSAL L/F (10) APPLICATOR COTION 6" WOOD (1) BALANCED SALT SOLUTION 18ML LIF (10) GAUZE SPONGE 4" X 4" 12P Y UF (1) LABEL BSS (1) TRAY 3/COMPARTMENT LIF (1) LABEL EPINEPHRINE VIOLET/WHITE (1) LABEL IODINE WHITE/BLACK Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1933, 20 lots: 112114613 112125046 113015506 113025815 113036476 113046936 113047008 113057440 113057613 113057842 113078288 113078581 113089021 113099282 113109641 131110072 131110603 131210966 140412831 140513465 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices UNIVERSAL PACK - (1) UTILITY BOWL 16oz. (1) NEEDLE SPINAL ANEST. 22G X 31!2 (1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK LIF (2) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK LIF (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK LIF (1) NEEDLE HYPODERMIC 20G X 1 1!2 (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED AAMIIII (1) SPLIT SHEET WITH ADHESIVE 108" X 77" SMS STD LIF (1) DRAPE % ECONOMY 53" X 77" UF (2) TOWEL ABSORBENT 15" X 20" UF (4) DRAPE UTILITY WITH TAPE LIF (1 0) GAUZE SPONGES 4" X 4" 12PL Y (4) TOWELS CLOTH HUCK BLUE (1) TABLE COVER REINFORCED 50" X 90" UF (1) SCALPEL WITH HANDLE #11 (3) PK. CLOSURE SKIN W' X 4" STERI STRIP UF (1) SKIN MARKER WITH RULER (1) DENTURE CUP 8oz WITH LID (1) NEEDLE HYPODERMIC 25 X 1 1!2 (1) STOCKINETTE IMPERVIOUS 14" X 48" (2) TIP ABSORB. APPLICATOR STICK SPONGE (1) TRAY ORGANIZER FULL DEEP (1) TRA 2/COMPARTMENT (1) RULER L/F Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1936, 22 lots: 110082088 110082207 110102439 110112627 110112928 111010082 111030630 111041100 111051372 111061520 111071785 111113056 111123422 112010103 112041214 112062469 112083415 113109769 131210637 140111090 140312098 140412891 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices ENDOVENOUS CUSTOM PACK - CUSTOMED (1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK L/F (1) Pr. GLOVE SYNTEGRA CR # 7.5 P/F LIF (2) Pr. GLOVE SYNTEGRA CR # 6.5 P/F LIF (20) GAUZE SPONGE 4" X 4" 12PL Y LIF (3) GOWN SMS X-LARGE STD NON REINFORCED ( 1) TABLE COVER 44" X 90" (4) DRAPE UTILITY WITH TAPE L/F ( 1) DENTURE CUP WITH LID ( 1) UTILITY BOWL 16oz. (2) COUNTER NEEDLE & BLADE 10c MAG/CLEAR L/F (4) RUBBER BAND ( 1) NEEDLE HYPODERMIC 27G X 1 Y.." ( 1) SHEET SPLIT WITH ADHESIVE 108" X 77" STD SMS LIF (3) CAP NURSE 21 " GREEN BOUFFANT (3) MASK SURGICAL BLUE 120MM HG LIF ( 1) PREPPING PAD WITH CUFF (2) TIP ABSORB. APPLIC. STICK SPONGE L/F ( 1) SCALPEL WEIGHTED SAFETY # 11 ( 1) PROBE DRAPE ST 6" X 96" NO GEL LIF ( 1) WRAPPER 30" X 30" (3) TOWELS ABSORBENT 15" X 20" L/F Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1937, 12 lots: 111082312 111113057 112020431 112051902 112062289 113025829 113026168 113067902 113088773 131210660 140211699 140312423 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices HIGADO & PANCREA PACK - (1) BAG SUTURE FLORAL (2) YANKAUER SUCTION TUBE WITHOUT VENT (4) DRAPE UTILITY WITH TAPE (6) TOWELS CLOTH HUCK BLUE (1) SHEET DRAPE 41 " X 58" SMS (1) MAYO TRAY LARGE (1) TABLE COVER REINFORCED 50" X 90" (1) DRAPE INCISE ANTIMICROBIAL 23" X 17" (1) DRAPE BARIATRIC (1) BLADE SURGICAL #10 STAINLESS STEEL (1) CUP SPECIMEN WITH CAP 4oz (1) BLADE SURGICAL #15 STAINLESS STEEL (30) LAP SPONGE PREWASH 18" X 18" XRD (1) STRIP STERI CLOSURE W X 4" (1) POLISHER CAUTERY TIP (1) NEEDLE ECLIPSE 22 X 1 Y2 (4) TOWEL ABSORBENT 15" X 20" (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK (2) LITE GLOVE (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER (1) COUNTER NDLE/BLADE 60C FOAM/STR/MAG/STR (1) FORCE TRIVERSE (1) SYRINGE BULB 60CC (1) BLADE EXTENDED ELECT. 16.51cm (2) TUBE SUCTION CONNECT Y." X 12' (2) CHLORAPREP 26ML APPLICATOR TEAL (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1966, 18 lots: 113025951 113026188 113036672 113047210 113067907 113078582 113099405 113109642 113109776 131110111 131110333 131210639 140111088 140211806 140312102 140412625 140412892 140513119 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices LAPAROSCOPY PACK - ( 1) APPLIER MULTI CLIP WITH SHAF GUN L/F ( 1) NEEDLE ULTRA VERES 120MM LIF ( 1) TROCAR ENDOPATH XCEL DILATING TIP (K11LT) LIF ( 1) TROCAR ENDO.XCEL DILATING TIP (KSLT) LIF (1) GOWN IMPERV. XTRA REINFORCED XL T/WRAP AAMI III (1) MAYO STAND COVER REINFORCED LIF (5) SPONGE LAP PREWASH 18" X 18" XRD LIF ( 1) CONTAINER SPECIMEN 40Z. WITH LID & LABEL LIF ( 1) BOWL UTILITY 16oz. LIF (1) SOLUTION SURGICAL DURAPREP 26ML ST. LIF (1) DRAPE LASER CAMERA W/EL 6" X 96" LIF (1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF (4) DRAPE UTILITY WITH TAPE LIF (4) TOWELS ABSORBENT 15" X 20" LIF (1) DRAPE ENDOSCOPY 100" X 123%" X 77" WITH TROUGHS L/F (2) SHEET DRAPE 42" X 57" SMS LIF (1) BLADE SURGICAL #11 STAINLESS STEEL ( 1) TIME OUT BEACON NON WOVEN ST L/F (6) GAUZE SPONGE 2" X 2" 4PL Y LIF ( 1) BLADE SURG. #15 CARBON STEEL ( 1) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill LIF (1) TABLE COVER REINFORCED 50" X 90" L/F Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1967, 19 lots: 111123453 112030696 112041219 112041457 112051908 112062470 112083417 112125164 113015692 113025952 113026107 113026233 113047010 113057694 113078292 140211807 140312103 140412626 140412893 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices TRAATEK NEURO PACK (4)TOWEL ABSORBENT 15" X 20" LIF ( 1) MAYO STAND COVER REINFORCED LIF ( 1) CAUTERY TIP POLISHER LIF (8) TOWEL CLOTH HUCK (BLUE) ( 1) BULB SYRINGE 60cc LIF ( 1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE (2) LITE GLOVE ( 1) TUBE SUCTION CONNECT. Y.." X 12' LIF ( 1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER LIF ( 1) DRAPE % ECONOMY 53" X 77" LIF ( 1) SHEET SPLIT W/ADHESIVE 77" x 146" (2) GOWN XL SMS IMPERVIOUS REINFORCED LIF (2) SYRINGE 60ml WITHOUT NEEDLE LUER LOCK LIF ( 1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF ( 1) STAPLE SKIN 35 WIDE LIF ( 1) TRAY MAYO LARGE (2) GOWN LGE SMS IMPERVIOUS REINFORCED LIF ( 1) SOLUTION SURGICAL DURAPREP 26ml LIF ( 1) Pk. NEUROPATTIES 0.45MM 10ea/pk ( 1) Pk. NEUROPATTIES 0.35MM 10ea/pk Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1983, 1 lots: 131110141 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices SHOULDER PACK- CUSTOMED- (1) TABLE COVER REINFORCED 50" x 90" LIF (2) MAYO STAND COVER REINFORCED L/F (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (4) TOWELS ABSORBENT 15" X 20" LIF (4) DRAPE UTILITY WITH TAPE LIF (2) GOWN IMPERVIOUS EXTRA REINFORCED LARGE (1) SHEET DRAPE 70" X 100" SMS LIF (1) CUP SPECIMEN WITH CAP 4oz (1) TUBE SUCTION CONNECT. Y." X 12' LIF (1) SKIN MARKER WITH RULER (1) SYRINGE 60ML WITHOUT NEEDLE LUER LOCK LIF (1) BAG SUTURE FLORAL LIF (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) NEEDLE HYPODERMIC 21G X 1% LIF (1) BLADE SURGICAL #11 CARBON STEEL (1) BLADE SURGICAL #15 CARBON STEEL (1) NEEDLE & BLADE COUNTER 60C FOAM STRIP/MAG STRIP LIF (1) NEEDLE SPINAL ANESTH. 18G X 3% LIF (1) STOCKINETIE IMPERVIOUS 14" X 48" LIF (1) DRAPE BEACH CHAIR SHOULDER ARTHROSC. (1) GOWN SURG. REINFORCED X-LARGE TOWEL/WRAP (2) GAUZE SPONGE 4" X 4" 16PL Y XRD L/F Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-1985, 16 lots: 112030698 112041408 112083418 112093632 112114384 112114490 112125051 113025843 113026052 113026108 113036788 113057730 113078294 113088775 113099406 140111191 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices O.B. PACK - ( I) PVP SCRUB 8" STICK SPONGES ( I) UNDERBUTTOCK DRAPE WITH POUCH (2) LEGGINS WITH 7" CUFF 30" x 42" ( I) DRAPE ABDOMINAL WITH TAPE LIF ( I) VAGINAL PACKING SPONGEXRD ( I) BOWL WITH LID PLASTIC 80oz ( I) RECEIVING BLANKET 100% COTTON (I) BABY BLANKET POLY ABSORBENT IMPERVIOUS (I) CORD UMBILICAL CLAMP (4) TOWELS ABSORBENT 15" x 20" LIF ( I) UTILITY BOWL 16oz. (2) TRAY ORGANIZER FULL DEEP (3) T IP ABSORBENT APPLICATOR (2) GLOVES EXAM MEDIUM (2) GOWN LARGE SMS IMPERVIOUS REINFORCED (10) GAUZE SPONGE 4" X 4" 12PLY (2) PAD OBSTETRJCAL X-LARGE ST. (I) EAR ULCER SYRINGE 2oz. LIF (I) BABY BEANNIES (2) SHEET DRAPE 4 1" x 58" SMS LIF (I) SCISSORS UMBILICAL (I) TABLE COVER REINFORCED 50" x 90" LIF (2) WRAPPER 24" X 24" L/f Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2002, 23 lots: 111113064 111123196 111123470 112010109 112041220 112051915 112062471 112083419 112093922 112104298 112114657 112125310 113015054 113015437 113067910 113088778 113089204 113099408 131110220 140111321 140211502 140211932 140312439 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on differ catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices GENERAL PACK - CONTENTS: (4) ABSORBENT TOWEL 15" x 20" LIF (1) MAYO STAND COVER REINFORCED LIF ( 1) NEEDLE & BLADE COUNTER 20c FOAM/MAG LIF (2) UTILITY BOWL 16 oz. LIF (1) GLASINE BAG PLAIN ( 1) SUTURE BAG FLORAL (4) DRAPE UTILITY WITH TAPE LIF ( 1) TABLE COVER REINFORCED 50" X 90" LIF (1) SURGICAL BLADE# 10 STAINLESS STEEL ( 1) SURGICAL DURAPREP SOLUTION 26mL LIF ( 1) LAPAROTOMY T DRAPE STD SMS (2) DRAPE SHEET 41" X 58" SMS LIF (2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS LIF (1 0) GAUZE 4"X 4" X 4 PLY ( 1) CAUTERY TIP POLISHER LIF (5) LAP SPONGES PRE-WASH XRD LIF ( 1) CAUTERY PENCIL ROCKER SWITCH LIF (1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF ( 1) TUBE SUCTION CONNECT. 3/16" X 12' LIF ( 1) SURGICAL BLADE# 15 CARBON STEEL ( 1) CONTAINER SPECIMEN 4 oz. WITH LID & LABEL Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Product code 900-2003, 29 lots: 112030702 112041277 112062472 112093923 112103923 112114386 112114472 112125311 113015438 113025954 113026205 113036457 113047011 113047156 113057447 113057696 113057814 113068159 113078779 113089205 113099569 131110221 131110405 131110582 140211725 140211874 140312378 140312461 140412832 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on differ catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices LAPAROSCOPY CHOLE PACK - (6) TOWELS ABSORBENT 15" X 20" LIF (1) MAYO STAND COVER REINFORCED L/F (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF (1) SURGICAL BLADE #11 CARBON STEEL (1) TUR Y SET, 2LEAD L/F (4) DRAPE UTILITY WITH TAPE LIF (1) TROCAR ENDO. XCEL DILATING TIP 5mm (K5LT) (1) ULTRA VERES NEEDLE 120mm (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG LIF (1) DRAPE LAP. ABDOM. WITH POUCH 102" X 122" X 78" (2) DRAPE SHEET 41" X 58" SMS (2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD L/F (5) LAP SPONGE PREWASH XRD LIF (1 ) DRAPE LASER CAMERA W/EL. 6" X 96" LIF (1) TUBE SUCTION CONNECT. 3/16" X 12' LIF (1) TROCAR ENDOPATH XCEL DILATING TIP 11mm (K1 1LT) (1) TUBING INSUFLATION SET W/0 RING ADAPTOR LIF (1) SURGICAL DURAPREP SOLUTION 26ML LIF (1) TABLE COVER REINFORCED 50" X 90" LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Product code 900-2004, 11 lots: 112030703 112061278 112114387 112114491 112114877 113068160 113078570 113089022 113099283 131110222 140613472 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on differ catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices CESAREAN PACK - (1) BABY BLANKET IMP. POLY ABS. (4) ABSORBENT TOWELS 15" x 20" LIF (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF (2) LITE GLOVES LIF (1) BOWL PLASTIC WITH LID 80 oz. (1) C-SECTION DRAPE W/ POUCH 102" X 121 " X 78" (1) UTILITY BOWL 32 oz. (10) LAP SPONGES PRE-WASHED XRD LIF (2) PAD OBSTETRICAL XLGE (1) BABY BEANNIES (1) MAYO STAND COVER REINFORCED L/F (1) DRAPE SHEET 41" X 58" SMS LIF (1) TUBE SUCTION CONNECT. X" X 12' L/F (1) EAR ULCER SYRINGE 2oz. LIF (1) RECEIVING BLANKET 100% COTION (1) YANKAUER SUCT TUBE WITHOUT VENT L/F (1) UMBILICAL CORD CLAMP (2) WRAPPER 20"X 20" (1) DRESSING ISLAND 4" X 10" (1) SCALPEL# 10 WITH HANDLE S/S (1) SCALPEL# 20 WITH HANDLE (1) TABLE COVER REINFORCED 50" X 90" L/F (1) MAYO TRAY SMALL (1) MUCUSTRAP 20cc 1 OFr. (2) GOWN LGE SMS IMPERVIOUS REINFORCED (1) SURGICAL DURAPREP SOLUTION 26mL L/F Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2005, 14 lots: 111123199 112030704 112041279 112051918 112083420 112125056 113036459 113047202 113057860 113078296 113088780 113109780 140211726 140412462 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on differ catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices ANGIOGRAPHY PACK CONTENTS: (4) CLOTH HUCK TOWEL BLUE (1) TABLE COVER REINFORCED 50" x 90" LIF (2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK L/F (2) CUP MEDICINE 2oz LIF (2) UTILITY BOWL 32oz LIF (1) EMESIS BASIN 101N 700cc (4) TOWEL CLAMP (3) TOWELS ABSORBENT 15" x 20" LIF (1) MOSQUITO HALSTED (2) CHLORASCRUB SWABSTICK 5.1ML (1) PLATFORM TRAY LARGE (1) SCALPEL SAFETY #11 (3) LABELS FOR SKIN MARKER (1) LABEL F/MED. SALINE NORMAL BLUE (1) NEEDLE HYPODERMIC 18G X 1 Y2 (2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) UTILITY BOWL 16oz (4) BAND BAG WITH RUBBAND & TAPE LIF (20) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) FEMORAL ANGIOGRAPHY DRAPE WITH POUCH (1) NEEDLE HYPODERMIC 21G X 1 Y2 (1) GOWN STANDARD SMS LARGE (2) NEEDLE HYPODERMIC 23GA X 1" (1) GOWN SMS LARGE NON REINFORCED TOWEL/WRAP (1) LABEL FOR MEDICATION TRIDIL VIOLETA (1) LABEL XYLOCAINE FOR MEDICATION YELLOW (1) LABEL CONTRASTE FOR MEDICATION GREEN (1) WASH BASIN ROUND 6QT. Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2038, 21 lots: 112114658 112125063 113026054 113036790 113047157 113057456 113067865 113068044 113078304 113078602 113099284 113109785 131110231 131110604 131211016 131211023 140111450 140311934 140412464 140412897 140513123 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on differ catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices ORTHOPEDIC SURGICAL PACK HOSPITAL SAN CRISTOBAL CONTENTS: (I) CAUTERY TIP POLISH ER LIF (1) BAG SUTURE FLORAL (1) TUBE SUCTION CONNECT W' X 1 2' LIF (1) BAG GLASSINE (2) LITE GLOVE (1) TABLE COVER BTC 77" X 11 0" HD FULL COVERAGE LIF (1) MAYO STAND COVER REINFORCED LIF (5) TOWELS ABSORBENT 1 5" X 20" LIF (4) DRAPE UTILITY WITH TAPE LIF ( 1 ) DRAPE SHEET 70" X 100" L/ F (5) LAP SPONGE PREWASH 18" X 1 8" XRD LIF (1 ) MAYOTRAYLARGE (1) DRAPE TOP WITH ADHESIVE 108" X 50" STD SMS LIF (1) SKIN STAPLER WIDE 35 LIF ( 1) DRAPE INCISE ANTI M I CROBIAL 23" X 1 7" LIF (1) SKIN MARKER WITH RULER (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6" X 2 1 " LIF (1 ) PAD ABDOM INAL 8" X 7"h.'' (1) YAUNKAUER SUCTION TUBE WITHOUT VENT LIF (1) SOLUTI ON SURG ICAL DURAPREP 26ML LIF (1 ) BLADE SURG ICAL #10 STAINLESS STEEL (I) SPLIT SHEET WITH ADHESIVE 108" X 77" STD SMS LIF (2) *Prs. GLOVE # 8.5 SURGEON NEUTRALON LATEX ( I ) *Pr. GLOVE# 8 SURGEON NEUTRALON LATEX ( I ) GOWN SURG. REINFORCED XL TOWEL/WRAP AAMI Ill (3) GOWN XL SMS IM PERVIOUS REINFORCED AAM I III LIF ( I ) CAUTERY PENCIL ROCK ER SWITCH (2) *Prs. GLOVES SURG. # 8 POWDER (4) Prs. GLOVES SURG. 8.5 Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2039, 7 lots: 112062199 113026170 113057698 113099418 131110232 140311817 140312114 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on differ catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices OPEN HEART TRAY PACK A CONTENTS: (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE LIF (1) MAYO STAND COVER REINFORCED L/F (3) TOWEL ABSORBENT 15" X 20" LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) SPLIT SHEET BILATERAL 84" X 80" (12) % SHEET 60" X 77" DRAPE REINFORCED LIF (1) MAYO TRAY LARGE (1) CV DRAPE SPLIT CARDIO WITH CLEAR ANEST. SC STD SMS (15) TOWELS CLOTH HUCK BLUE (4) TOWELS CLOTH HUCK WHITE (2) STOCKINETTE IMPERVIOUS 14" X 48" LIF (30) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) WRAPPER 54" X 54" (3) LITES GLOVE LIF OPEN HEART TRAY HOSPITAL HERMANOS MELENDEZ PACKB CONTENTS: (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE LIF (1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL (2) CATHETER THORACIC 32FR. STRAIGH (2) PENCIL CAUTERY ROCKER SWITCH LIF (3) TUBE SUCTION CONNECT W X 12' LIF (2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) LABEL SET, HEPARINE SALINE (2) CAUTERY TIP POLISHER LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) BANDAGE ELASTIC 6" X 5yds LIF (2) YANKAUER SUCTION TUBE WITHOUT VENT LIF (2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) NEEDLE HYPODERMIC 25G X 5/8 ST. (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) NEEDLE HYPODERMIC 27G X %" ST. (1) NEEDLE & BLADE COUNTER 60C MAG/MAG (2) BOWL UTILITY 16oz. (4) FEEDING TUBE 8FR, 15" LONG (2) BULB SYRINGE 60cc (1) TRAY PLATFORM LARGE (1) SKIN MARKER WITH RULER (1) CATHETER 18FR SUCTION W/STRA LIF (1) WRAPPER 54" X 54" UF (1) BLADE SURGICAL #10 CARBON STEEL (1) BLADE SURGICAL #15 CARBON STEEL (2) BLADE SURGICAL #11 CARBON STEEL (1) BLADE SURGICAL #20 CARBON STEEL OPEN HEART TRAY HOSPITAL HERMANOS MELENDEZ PACKC CONTENTS: (9) TOWELS ABSORBENT 15" X 20" UF (6) GOWN FAB REINFORCED SONTARA X-LARGE (1) GOWN IMPERVIOUS XTRA REINFORCED X-LARGE TOWEL & WRAP LEVEL Ill (1) TABLE COVER REINFORCED 44" X 78" UF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2114, 12 lots 112030719 112041222 112051939 112083124 112093924 112125069 113025796 113026055 113026076 113036761 113057459 113088787 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on differ catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices NEURO SPINE PACK CONTENTS: (1) SUTURE BAG FLORAL LIF (1) NEEDLE & BLADE COUNTER SOC FOAM STR//MAG STR (2) COVER TABLE BTC 77" x 110" HD FULL COVERAGE LIF (4) DRAPE UTILITY WITH TAPE LIF (1) SHEET 'I" 60" X 77" DRAPE REINF. LIF (2) SPECIMEN CONTAINER 4oz W/LID & LABEL (2) CUP MEDICINE 2oz UF (2) TUBE SUCTION CONNECT v.'' X 12' UF (2) SKIN MARKER INK WITH 8 LABEL (20) GAUZE SPONGE 4" X 4" 16ply XRD UF (5) SPONGE LAP PREWASH 18"X 18" XRD UF (2) SYRINGE 20cc W/0 NDL LILOCK ST.LIF (1) YANKAUER SUCT. TUBE W/0 VENT LIF (1) DRAPE INCISE ANTIMICROBIAL 23" X 17" LIF (1) POLISHER CAUTERY TIP LIF (2) PENCIL CAUTERY HAND SWITCHING LIF (1) DRAPE T LAPAROTOMY 102" X 78" X 121" STD SMS LIF (1) GOWN SURG REINFORCED LARGE TOWEL WRAP (2) BLADE SURG #15 CARBON STEEL (1) PK.STRIP SURGICAL %" X 6" COTTON (1) PK.STRIP SURGICAL Y4" X 6" COTTON (10) GAUZE SPONGE 4" X 4" 16ply (1) NEEDLE HYPODERMIC 20G X 1 % (1) BASIN WASH ROUND 6qt (4) SHEET DRAPE 42" X 57" SMS LIF (2) DERMABOND HV TOPICAL SKIN ADH (1) BOWL UTILITY 32oz. (2) SYRINGE EAR/ULCER 2oz LIF (2) BLADE EXTENDED ELECTRODE (2) SOLUTION SURGICAL DURAPREP 26mL UF (1) ELECTRODE NEEDLE 1in W/TIP PROTECTOR (1) STRIP SURGICAL 'I"X 6" (2) GOWN XL SMS IMPERV. REINFORCED UF (1) CORD BIPOLAR FIRCEPS (4) TOWEL CLOTH HUCK (WHITE) (2) DRESSING OPSITE POST PO 2%" x 2" (2) POUCH INSTRUMENT 7 X 11 (1) MAYO TRAY LARGE (1) MAYO STAND COVER REINFORCED UF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2122, 1 lot: 112124868 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices KNEE ARTHROSCOPY PACK CONTENTS: (1) TOWEL ABSORBENT 15" X 20" L/F (10) GAUZE SPONGE 4" X 4" 16PLY (1) SAFETY IV INTROCAN 18 X 1Y. ST. LIF (1) NEEDLE HYPODERMIC 18G X 1Y:z (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (1) SKIN MARKER INK W/8 LABEL (2) TUBE SUCTION CONNECT. W X 12' LIF (1) CAST PADDING SOFT ROLL 6 X 4yds L/F (2) BANDAGE ELASTIC 6" X 5yds L/F (4) STRIP TAPE 24" X 4" LIF (1) Pk. STERI STRIP CLOSURE Y:z" X 4" LIF (1) SHEET ARTHROSCOPY "T" STD SMS W/POUCH L/F (5) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) NEEDLE SPINAL ANESTHESIA 18G X 3% LIF (1) SYRINGE 10cc W/0 NDL L/LOCK LIF (1) DRAPE VIDEO CAMERA 13cm X 244cm LIF (1) GOWN IMPERV. XTRA REINF. LGE TIWRAP (1) MAYO STAND COVER REINFORCED LIF (2) NEEDLE HYPODERMIC 25 X 1Y:z LIF (1) TIME OUT BEACON NON WOVEN ST. LIF (1) STOCKINETTE IMPERV. 14" X 48" LIF (1) TABLE COVER REINF. 50" X 90" LIF (1) SCALPEL WEIGHTED SAFETY #11 (1) SAFETY GLIDE NEEDLE 21G X 1% (1) GOWN SURG. REINF. XL EXTRA LONG LEVEL IV Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2123, 22 lots 112041293 112041377 112051685 112083162 112093925 112104110 112114603 113015564 113026273 113036460 113036691 113078467 113088788 113109787 131110236 131210645 140111094 140211658 140312117 140412557 140513124 140613657 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices FEMORAL PACK CONTENTS: (2) TOWELS ABSORBENT 15" X 20" LIF (2) DRAPE SHEET 42" X 57" SMS LIF (1) SAFETY IV INTROCAN 18 X 1X ST. LIF (2) GOWN LGE SMS IMPERVIOUS REINFORCED LIF (2) VESSEL LOOP SURGICAL MAXI BLUE (1) SUTURE AID BOOT STD YELLOW ST. LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT L/F (1) EMESIS BASIN 101N 700cc LIF (2) LIGHT SHIELD (1) NEEDLE HYPODERMIC 18G X 1 L/F (1) CATHETER IV SAFETY 20G X 1X LIF (1) DRAPE T LAPAROT 102" X 78" X 121" SMS STD LIF (10) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) MAYO STAND COVER REINFORCED LIF (1) STOCKINETTE IMPERVIOUS 14" X 48" LIF (2) SYRINGE 20cc WITHOUT NEEDLE LUER I LOCK LIF (1) SUTURE BAG FLORAL LIF (2) UTILITY BOWL 16oz. L/F (1) CAUTERY TIP POLISHER LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (4) DRAPE UTILITY WITH TAPE LIF (1) MAYO TRAY SMALL (1) SCALPEL SAFETY WEIGHTED #15 (1) SCALPEL SAFETY WEIGHTED #11 (2) TUBE SUCTION CONNECT X" x 12' LIF (2) NEEDLE & BLADE COUNTER, 1Oc MAG/CLEAR LIF (1) TIME OUT BEACON NON WOVEN ST. LIF (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER L/F Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2164, 11 lots 112041224 112083167 113036762 113047217 113067914 113078468 113088852 131210646 140312118 140412645 140513125 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices LITHOTOMY PACK CONTENTS: (2) TOWELS ABSORBENT 15" X 20" (2) LEGGINGS W/7'' CUFF 30" X 42" CSR (1) DRAPE UNDERBUTTOCK WITH POUCH 44" x 35" (1) DRAPE ABDOMINAL WITH TAPE 40" X 54" (1) DRAPE UTILITY WITH TAPE (1) TABLE COVER REINFORCED 50" X 90" (1) TIME OUT BEACON NON WOVEN ST. Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2167, 29 lots 111041037 111051291 111061531 111102864 112010130 112020462 112030812 112041223 112051942 112062480 112072798 112083163 112083421 112093927 113057460 113067915 113078469 113088789 113089024 113109643 113109789 131110238 131210786 140111203 140312119 140412646 140513126 140513397 140613659 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices HIP PACK CONTENTS: (2) TOWELS ABSORBENT 15" X 20" (2) GOWN XL SMS IMPERV. REINFORCED (1) MAYO STAND COVER REINFORCED (1) SUTURE BAG (1) DRAPE UTILITY WITH TAPE (1) STOCKINETTE IMPERV. 14" X 48" (1) U-DRAPE 54 X 72 WITH TAPE SPLIT HIP DRAPE 89" X 128" WITH POUCH TABLE COVER REINFORCED 50" X 90" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Product code 900-2184, 4 lots 111041038 111071378 111082085 112062292 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices SHOULDER ARTHROSCOPY PACK CONTENTS: (1) SUTURE BAG FLORAL (1) UTILITY BOWL 32oz. (2) DRAPE SHEET 70" X 100" (1) GOWN SURG REINFORCED XLGE T/WRAP (1) NEEDLE SPINAL ANESTH. 18G X 3ST. (1) STOCKINETTE 6 X 48" (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK (1) SCALPEL WEIGHTED SAFETY# 11 (1) BULB SYRINGE 60cc (1) DRAPE BEACH CHAIR SHOULDER ARTHROSCOPY (10) LAP SPONGE PREWASH 18" X 18" XRD (2) U-DRAPE 60" X 70" WITH TAPE SPLIT (2) DRAPE SHEET 41" X 58" SMS (1) STOCKINETTE IMPERVIOUS 14" X 48" (1) TABLE COVER REINFORCED 50" X 90" (1) COBAN WRAP TAN 4" X 5yds (1) TIME OUT BEACON NON WOVEN (2) GOWN SURG. REINFORCED XL EXTRA LONG LEVEL IV (2) MAYO STAND COVER REINFORCED (1) SKIN MARKER INK WITH 8 LABEL (1) TUBE CONNECTING SUCTION X" X 12' (1) MAYO TRAY SMALL ( 1) CAMERA COVER W/ELAST. Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2193, 28 lots 111082204 111092380 111113084 111123219 111123426 112041379 112083164 112093928 113015445 113026056 113036438 113036728 113046937 113057461 113067867 113078470 113078790 113099287 113109790 131110074 131110499 131210647 131210968 140111415 140311935 140312380 140412834 140513127 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices LAPAROSCOPY PACK CONTENTS: ( I ) BULB SYRINGE 60cc LIF ( I 0) GAUZE SPONGE 4" X 4" 1 6PLY XRD LIF ( I ) MAYO STAND COYER REINFORCED LIF ( I ) TABLE COVER REINFORCED 50" X 90" LIF (3) GOWN SURG. REINFORCED XL EXTRA LONG LEVEL I V (4) TOWEL ABSORBENT I 5" X 20" LIF ( I ) DRAPE VIDEO CAMERA I 3cm X 244cm LIF (3) LITE G LOVE LIF ( I ) DRAPE LAP ABDOM. WI POUCH 102" X 122" X 78" ( I ) BLADE SURG ICA L # II STAIN LESS STEEL ( I) SYRINGE I Occ W ITHOUT NEEDLE LUER LOCK LIF (4) DRAPE UTILITY WITH TAPE LIF ( I ) SUTURE BAG FLORAL (I) NEEDLE & BLADE COUNTER I OC MAG I C LEAR L/1' ( I ) CABLE LAP. IOFR 4MM MALE MONOP. LIF (2) DRESSING NON ADH TELfoA 4 X 3 ( I ) SPECIMEN CONTAINER 4oz WITH LID & LABEL (2) SH EET 'll.o 60" X 77" DRAPE R EI NFORCED LIF ( I ) TUBING INSUFFLAT SET WIO RING ADAPTOR LIF ( I ) CI-I LORAPREP 26ML APPLICATOR TEAL LIF ( I ) WRAPPER 24" X 24" (2) DENTURE CUP 8oz WILID ADHERED OUTSIDE OF THE PACK INTO A POUCH: ( I ) NEEDLE ULTRA VERES 1 20MM LIF ( I ) TROCAR ENDO.XCEL DILATING TIP IIM M (D IILT) ( I ) TROCA R ENDO.XCEL DILATING TIP LIF (K5LT) ( I ) CANNU LA 5MM XCEL SLEEVES LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2204, 5 lots 112050723 112062283 112083422 112093930 112125070 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices SURGICAL PACK CONTENTS: (1) SUTURE BAG FLORAL (1) WRAPPER 30" X 30" (2) UTILITY BOWL 16oz (1) TRAY ORGANIZER FULL DEEP (1) SPECIMEN CONTAINER 4oz W/LID & LABEL (1) YANKAUER SUCTION TUBE WITHOUT VENT (5) LAP SPONGE PREWASH 18" X 18" XRD (1) BLADE SURG. #15 CARBON STEEL (2) NEEDLE & BLADE COUNTER 1Oc MAG/CLEAR (1) CAUTERY TIP POLISHER (1) BLADE SURG. #10 CARBON STEEL (2) LITE GLOVE (10) GAUZE SPONGE 4" X 4" 16PLY XRD (1) CAUTERY PENCIL ROCKER SWITCH (1) TIME OUT BEACON NON WOVEN ST Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2224, 31 lots 111030809 111040974 111051186 111051439 111061657 111123221 112010132 112020464 112030725 112041296 112083423 112093932 112114389 112114662 113015447 113025955 113026235 113036792 113057462 113067868 113078471 113088791 113099288 113109791 131110239 140111204 140211659 140312122 140312381 140412899 140513478 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices EAR PACK CONTENTS: ( I ) B LADE SU RG ICA L # 15 CARBON STEEL ( I ) EMESI S BASIN lO in 700cc ( I ) GOWN XL SMS IM P. REINFORCED ( I ) NEEDLE HYPODERM IC 1 8G X I 'h ( I ) WASH BASIN ROUND 6QT ( I ) INSTRUMENT POUCH 7 X II 2COMPARTMENT (I) STERI STR I P CLOSURE 'h" X 4" ( I) SYRINGE 3cc WITHOUT NEEDLE LILOCK (2) SYRINGE I ML WITHOUT NEEDLE LILOCK (I) CAUTERY TIP POLISHER (I) SHEET ENT SPLIT 110" X 77" SMS ( I ) GOWN I MP XTRA REINF. SMS XLT/ W LEVEL I V (2) LITE GLOVE (1 2) TOWELS CLOTH HUCK (BLUE) ( I ) TUBE SUCTION CONNECT W' X 1 2' (I) EAR ULCER SYRINGE 2oz (I) TABLE COYER REINFORCED 50" X 90" ( I) UTILITY BOWL 16oz (4) APPLICATOR COTTON 6" WOOD (2) STRJPS TAPE 24" X 4" ( I ) GOWN LGE SMS I MPERVIOUS REINFORCED ( I ) WIPE INSTRUMENT LMM 8.25 X 8.25 ( I ) MAYO STAND COYER REINFORCED ( I ) NEEDLE & BLADE COUNTER 20c FOAM/ MAG ( I ) SYRINGE I Occ WITHOUT NEEDLE LILOCK ( I ) MAYOTRAY SMALL ( I ) SYRINGE I Occ TI P CONTROL LUER LOCK ( I ) DRAPE M ICROCOSPE LE I CA 42 X 105 ( I ) TI ME OUT BEACON NON WOVEN (I) BLADE M IN IATURE CARBON STEEL (10) GAUZE SPONGE 4" X 4" 1 6PLY XRD (I) SK I N MARKER INK W/8 LABEL (2) NEEDLE HYPODERM I C 27G X I W' ONE PACK WET SK IN W ITH CONTENTS: ( I ) WRAPPER SMS 30" X 30" (2) COTTON TIP APPLICATOR 6" WOOD (2) GLOVE MED FREETOUCH VYNIL P/F (6) SPONGE W ING SMALL (4) TOWELS ABSORBENT 1 5" X 20" (3) TIP ABSORB. APPLICATOR STI CK SPONGE ( I ) PVP IODOPHOR PAINT 4oz. BOTTLE (I) PVP SCRUB SOLUTION 4oz. BOTTLE (I) TRAY 3/COMPARTMENT Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2234, 8 lots 112030726 113088792 113109792 131110112 131110338 140211660 140412835 140512993 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices NEURO PACK CONTENTS: (4) TOWEL ABSOSRBENT 15" X 20" LIF ( I ) BAG BI OH AZARD 30" X 37" (2) MAYO STAND COYER REINFORCED UF (20) GAUZE SPONGE 4" X 4" 1 6PLY XRD UF ( I ) CAUTERY POLISHER TIP LIF ( I ) BLADE SU RGICAL# II CARBON STEEL (I) TRAY MAYO LARGE (8) TOWELS CLOTH I-l UCK (BLUE) (2) WASH BASIN ROUND 6QT ( I ) NEEDLE HYPODERMIC 1 8G X I \12 ST. (2) UTI LITY BOWL QUART 32oz. (2) BULB SYRINGE 60cc LIF (2) NEEDLE & BLADE COUNTER, IOC M/CLEAR LIF (2) PVP SCRUB 8'' STICK SPONGE ST. (I)SKIN STAPLE 35 WIDE ST. LIF (2) SYRINGE 60ML W/0 NEEDLE LILOCK LIF (2) LITE GLOVE (I) TABLE COYER BTC 79" X 110" HD FULL COVERAGE LIF (2) TUBE SUCTION CONNECT. W' X 1 2' LIF (4) DRAPE UTILI TY WIT APE LIF (5) LAP SPONGE PREWASH 1 8" X 1 8" XRD LIF (I) CAUTERY PENCIL ROCKER SWITCH UF (2) BLADE SURG I CA L # I O CARBON STEEL (I) BLADE SURG I CAL#1 5 CARBON STEEL (I) SKIN MARKER INK W/8 LABEL (3) UTI LITY BOWL 1 6oz. L/F (2) PVP PAINT 8" STICK SPONGE ST. (7) DRAPE :V. ECONOMY 53" X 77" LIF (I)S UTURE BAG FLORAL (I) SY RINGE I Occ SLI P TI P ST. LIF (I) NEEDLE HYPODERM IC 22G X I \12 ST. (I) SOLUTION SURG I CAL DURAPREP 26M L LIF (I) GOWN SURG. REINFORCED LGE TOWEL/ WRAP (2) GOWN FAB REINFORCED X-LARGE SONTARA (I) DRAPE TLAPAROT. 1 02" X 78" X 1 21 " STD SMS Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2256, 12 lots 112041300 113026058 113047204 113057738 113078309 113088794 113109793 131110244 131110291 140111095 140412649 140513128 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices LAPAROSCOPIA COLORECTAL PACK CONTENTS: (1) SOLUTION SURGICAL DURAPREP 26ml (4) DRAPE UTILITY WITH TAPE (1) TOWELS ABSORBENT 15" X 20" (2) LEGGINS W/7" CUFF 30" X 42" (1) BLADE SURGICAL #15 STAINLESS STEEL (1) BLADE SURGICAL #11 STAINLESS STEEL (1) GOWN IMPERV. EXTRA REINFORCED XLG (1) GOWN LGE STANDARD SMS VELCRO NECK (1) IRRIGATION SUCTION TROMPET DUAL SPIKE (10) GAUZE SPONGE 4" X 4" 16PLY XRD (2) UTILITY BOWL 16oz (2) STERI STRIP CLOSURE W' X 4" (1) ACTIFOG W/FOAM PAD SOLUTION (1) TABLE COVER REINFORCED 50" X 90" (1) MAYO STAND COVER REINFORCED (1) NEEDLE ULTRA VERES 120MM (1) STAPLE ARTICULATING ECHEL 60MM (1) RELOAD WHITE 60MM ECHELON (1) RELOAD BLUE 60MM ECHELON (2) CANNULA 5MM XCEL SLEEVES (1) TROCAR 5MM BLADELE WITH STAB SLEEVE (1) TROCAR 12MM BLADELE WITH STAB SLEEVE (1) DRAPE LAP. ABDO W/POUCH 102" X 122" X 78" STD SMS Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2259, 17 lots 112083065 112114604 113015509 113025814 113036344 113046904 113056793 113057467 113067917 113078474 113088795 113099487 113109794 131110245 131210648 131211017 140211501 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices LAPAROSCOPY COLORECTAL SURGICAL PACK CONTENTS: (1) SOLUTION SURGICAL DURAPREP 26ml LIF (4) DRAPE UTILITY WITH TAPE LIF (3) TOWELS ABSORBENT 15" X 20" LIF (2) LEGGINS W/7'' CUFF 30" X 42" LIF (1) BLADE SURGICAL# 15 STAINLESS STEEL (1) BLADE SURGICAL# 11 STAINLESS STEEL (1) GOWN IMPERV. EXTRA REINF. XLG AAMI Ill LIF (1) IRRIGATION SUCTION TROMPET DUAL SPIKE LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (2) UTILITY BOWL 16oz. LIF (2) PK. STERI STRIP CLOSURE%'' X 4" L/F (1) ACTIFOG WITH FOAM PAD SOLUTION LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) MAYO STAND COVER REINFORCED LIF (1) NEEDLE ULTRA VERES 120MM LIF (1) STAPLE ARTICULATING ECHEL 60MM LIF (1) RELOAD WHITE 60MM ECHELON L/F (2) CANNULA 5MM XCEL SLEEVES LIF (1) TROCAR 5MM BLADELE W/STAB SLEEVE UF (1) TROCAR 12MM BLADELE W/STAB SLEEVE LIF (10) LAP SPONGES PREWASH 18" X 18" XRD LIF (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR LIF (2) LITE GLOVE (1) PENCIL CAUTERY ROCKER SWITCH WITH HOLSTER LIF (1) ELECTRODE DUAL DEPRES (1) LAPAROSCOPIC/LITHOTOMY DRAPE WITH CLEAR INSTRUMENT POUCHES (1) COUNTER NDLE/BLADE 20C FOAM/MAG LIF (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER LIF (1) BAG SUTURE FLORAL (1) GOWN IMPERV EXTRA REINFORCED LARGE TOWEL& WRAP LIF (1) POLISHER CAUTERY TIP LIF (1) BAG GLASSINE (1) RELOAD BLUE 60MM LIF (1) TIME OUT BEACON NON WOVEN LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2259A, 3 lots 140312025 140412651 140612902 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices CENTRAL LINE FULL BODY DRAPE CUSTOMED CONTENTS: (1) WRAPPER 30" X 30" (2) MASK SURGICAL W/ VISOR ANTI-FOG 160mm Hg (2) CAP NURSE 21" GREEN BOUFFANT (2) TOWELS ABSORBENT 15" X 20" (2) GOWN LARGE STANDARD SMS VELCRO/NECK (1) DRAPE SHEET 41" X 58" SMS (1) DRAPE BRACHIAL ANGlO 44" X 31" REINFORCED 3" ADHESIVE CIRCULAR FENESTRATION Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2262,8 lots 112041231 113036345 113047112 113078310 113088797 140111207 140211823 140312128 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices LAPAROSCOPY CHOLE SYSTEM PACK MIAMI METRO CON TENTS: (12) TOWELS CLOTH HUCK BLUE LIF (1) MAYO STAND COVER REINFORCED LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) SUTURE BAG FLORAL LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) BULB SYRINGE 60cc LIF (1) BLADE SURGICAL #10 STAINLESS STEEL (2) SHEET% 60" X 77" DRAPE REINFORCED LIF (10) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) BLADE SURGICAL #15 CARBON STEEL (1) TUBE SUCTION CONNECT Y." X 12' LIF (1) BAG GLASSINE PLAIN (1) CAUTERY TIP POLISHER LIF (1) DRAPE LAP. ABDOMINAL WITH POUCH 102" X 122" X 78" LIF (1) PK. STRIP STERI CLOSURE W' X 4" LIF (1) SKIN MARKER INK WITH 8/LABEL/TIME OUT/RULER L/F (1) CORD LAPAROSCOPY MONOPOLAR FOOD SWICHING (1) COUNTER NEEDLE BLADE 30c MAG/FOAM (1) TIME OUT BEACON NON WOVEN LIF (1) GOWN XL SMS IMPERVIOUS REINFORCED LIF (1) GOWN SURG. REINFORCED X LARGE TOWEL/WRAP LIF (1) TOWEL ABSORBENT 15" X 20" LIF (1) BLADE SURGICAL #11 CARBON STEEL (1) TUBING INSUFFLATION OPEN TIP WITHOUT VENT LIF (1) YANKAUER OPEN TIP CLEAR WITHOUT C IV LIF ATTACHED PACK WITH THE FOLLOWING STERILE COMPONENT: (1) ACTIFOG WITH/FOAM PAD SOLUTION LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2270,1 lot 112125073 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices LUMBAR PACK ADVANCED AMBULATORY SURGICAL CENTER CONTENTS: (1) COVER TABLE REINFORCED 50" X 90" UF (4) SYRINGE 3CC WITHOUT NEEDLE LUER LOCK UF (8) TOWELS CLOTH HUCK BLUE UF (1) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK UF (10) GAUZE SPONGE 4" X 4" 16PLY XRD UF (1) STRIP STERI DRAPE LARGE 17" X 23" UF (1) SCALPEL WITH HANDLE #11 (1) COVER FLUORO 30" X 30" WITH RUBBER BAND UF (1) DRAPE CHEST 100" X 142" X 72" (1) RULER FLEXIBLE PLASTIC (1) SOLUTION SURGICAL DURAPREP 26ML UF (1) SHEET :X 60" X 77" DRAPE REINFORCED UF (1) STRIP STERI CLOSURE%'' X 4" UF (2) GOWN SOFT SMS STD. XL SET IN SLEEVE UF (4) NEEDLE HYPODERMIC 18G X 1 % U (1) SKIN MARKER W/RULER UF (1) NEEDLE HYPODERMIC 25 X 1 % UF (1) DRESSING TELFA 8" X 3" NON ADH UF (1) DRESSING TEGADERM 4 X 4%" UF (1) STERI-STRIP COMPOUND BENZOIN TINT 2/3cc VIALL /F (1) BAG ZIP LOCK UF (9) LABELS FOR SKIN MARKERS UF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2284 ,5 lots 112083036 112125074 113026297 113057619 113078727 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices CERVICAL PACK ADVANCED AMBULATORY SURGICAL CENTER CONTENTS: (1) COVER TABLE REINFORCED 50" X 90" (1) COVER FLUORO 30" X 30" WITH RUBBER BAND (8) TOWELS CLOTH HUCK BLUE (1) SHEET :Y. 60" X 77" DRAPE REINFORCED (10) GAUZE SPONGE 4" X 4" 16PLY XRD (1) SKIN MARKER W/RULER (1) DRAPE THYROID 100" X 142" X 72" (1) TAPE TEGADERM 2-3/8 X 2-3/4 (1) SOLUTION SURGICAL DURAPREP 6ML (1) STERI-STRIP COMPOUND BENZOIN TINT 2/3cc VI (1) NEEDLE 30G X 1 DISP (2) GAUZE SPONGE 2" X 2" 4PLY NON WOVEN (1) STRIP STERI CLOSURE %'' X 4" (2) GOWN SOFT SMS STD XL SET IN SLEEVE (4) NEEDLE HYPODERMIC 18G X 1 % (1) RULER FLEXIBLE PLASTIC (4) SYRINGE 3CC WITHOUT NEEDLE LUER LOCK (1) BAG ZIP LOCK (1) STRIP STERI DRAPE LARGE 17" X 23" (9) LABELS FOR SKIN MARKERS Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2286 ,2 lots 112082968 113057620 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices LIPOSUCTION PACK AESTHETIC SURG.CENTER CONTENTS: (1) BLADE SURG. #11 CARBON STEEL (3) * GLOVE PERRY SURG. # 7LATEX (15) SPONGE LAP PREWASH 18" X 18" XRD L/F (4) * GLOVE PERRY SURG. # 7 LATEX (1) TABLE COVER REINF 50" X 90" LIF (2) GOWN SOFT SMS STD XL SET IN SLEEVE L/F (4) DRAPE SHEET 44" X 58" SMS LIF (1) TRAY ORGANIZER FULL DEEP (3) SHEET% 53" X 77" REINF. LIF (2) TOWELS ABSORBENT 15" X 20" LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2290 ,2 lots 112030728 112041301 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices FACE PACK AESTHETIC SURGERY AESTHETIC SURGERY CONTENTS: (15) APPLICATOR COTION 6" WOOD (60) GAUZE SPONGE 4" X 4" 16 PLY SOFT LIF (2) NEEDLE SPINAL ANEST 22G X 3 Y2 LIF (8) TOWELS CLOTH HUCK BLUE LIF (2) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK LIF (6) BLADE #15 CARBON RIB (1) SHEET ENT SPLIT 110" X 77" SMS L/F (3) *Pr. GLOVE PERRY SURG # 7.5 LATEX (5) SPONGE LAP PREWASH 18" X 18" XRD LIF (1) COVER TABLE REINFORCED 50" X 90" LIF (2) COTTON BALL MED (3) *Pr. GLOVE PERRY SURG # 7 LATEX (1) DRAPE INST. MAGNETIC 10" X 16" L/F (2) NEEDLE 30G X 1 DISP LIF (1) MARKER SKIN WITH RULER LIF (4) LABELS FOR SKIN MARKERS 1.25 X Y2 (1) COUNTER NEEDLE AND BLADE 15C FOAM I MAG STRIP LIF (2) GOWN SOFT SMS STD X-LGE SET IN SLEEVE LIF (1) RULER 6" FLEXIBLE (1) BAG ZIP LOCK 6" X 10" PLASTIC Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2291 ,2 lots 112010139 112020467 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices ORTHO PACK EXTREMITY CUSTOMED CONTENTS: (1) TABLE COVER REINFORCED 50" X 90" (1) MAYO STAND COVER REINFORCED (1) SUTURE BAG FLORAL (1) STOCKINETTE IMPERVIOUS 14" X 48" (1) U-DRAPE 60" X 70" WfTAPE SPLIT (1) SHEET EXTREMITY ABS. 125" X 85" (1) GOWN SOFT SMS STD. XLGE SET IN SLEEVE (1) WRAPPER 24" X 24" (1) TOWELS ABSORBENT 15" X 20" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2356 ,3 lots 112010142 112010284 112020522 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices VAGINAL PROCEDURE PACK CUSTOM ED CONTENTS: (1) DRAPE LITHOTOMY 110" X 63" W/LEGGINGS I POUCH FEN 3 X 6 SMS LIF (1) GOWN XL SMS IMPERV. REINFORCED LIF (1) COVER MAYO STAND REINFORCED LIF (1) BAG SUTURE FLORAL (1) COVER TABLE REINF 50" X 90" LIF (1) TUBE SUCTION CONNECT. W' X 12' LIF (1) GOWN SURG REINF XL T/WRAP (20) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF (1) PENCIL CAUTERY HAND SWITCHING (1) PVP PAINT 8" STICK SPONGE (1) PVP SCRUB 8" STICK SPONGE (1) SYRINGE 20cc W/0 NDL LUER LOCK LIF (1) TOWEL ABSORBENT 15" X 20" LIF (1) YANKAUER SUCTION TUBE W/0 VENT LIF (1) PRE PAD WITH CUFF (1) PACKING VAGINAL XRD 4" X 36" 8PLY (2) PAD OBSTETRICAL XL (1) CATHETER 2/W 16Fr. PRESS W/UBAG 2000ML (1) TIME OUT BEACON NON WOVEN LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2385 ,7 lots 112041304 112093771 113057712 113078586 113099428 120051955 140613805 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices TOTAL HYCTERECTOMY (I) CANNULA 5MM XCEL SLEEVES LIF ( I ) TROCAR XCEL BLADELESS II MM (I) TROCAR 5MM BLADELESS W/STAB SLEEVE LIF ( I) NEEDLE ULTRA VERES 120MM LIF ( I) TUBING INSUFFLAT SET W/0 R ING ADAPTOR LIF (I) DRAPE VIDEO CAMERA 13cm X 244 em LIF ( I ) DRAPE LAP ABDOM W/POUCH 1 02" X 1 22" X 78" STD SMS (2) LEGGINGS W/7" CUFF 30'' X 42" ( I ) SAFETY SCALP EL # II S/STEEL ( I ) GOWN IMPERV. XTRA REINF. XL T/WRAP LEVEL III ( I ) TABLE COY ER REINFORCED 50" X 90" LIF (4) DRAPE UTILITY WIT APE LIF (2) DRAPE SI-IEET 42" X 57" SMS (I) TUBE SUCTION CONNECT Y." X 1 2' LIF ( I ) MAYO STAND COYER REINFORCED LIF (1 0) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (4) TOWELS ABSORBENT 1 5" X 20" LIF (2) LITE GLOVE ( I ) DRAPE UNDERBUTTOCK W/ PO UCl-144" X 35" (2) SYRINGE I Occ W/0 NEEDLE LILOCK LIF (2) SPEC IMEN CONTA INER 4oz W/LID & LABEL (1 5) LAP SPONGE PREWASH 18'' X 1 8" XRD LIF ( I ) PVP PAINT 8" STICK SPONGE ( I ) UTILITY BOWL QUART 32oz LIF ( I ) ELECTRODE DUAL DEPRES ( I) DRESSING OPSITE POST PO 2!12 X 2" ( I ) MERLINO SK IN PREP APPLIC. 39ML LIF (3) GOWM XL SMS IMPERVIOUS REINFORCED LIF ( I ) CORD LAPAROSCOPY MONOPOLAR FOOD SWICH ING (1) FOLEY CATHETER KIT CONTAINING: (I) CATHETER 1 6FR FOLEY 2WAY, Sec (I) PYP TR IPLE SWABSTICK IODOPHOR (2) SWABSTICK DRY COTTON ( I ) SYR I NGE IOcc WATERFREFIL LIF (2) GLOVE MED FREETOUCH YYN I L P/F (I) TOWEL3PLYPOLY 17" X 18" (I) DRAPE 4" FENESTRATED 18" X 26" (I) LABEL lD PATIENT (I) JELLY LUBRI CATING FIVE GRAM ( I ) URINARY BAG DRAINAGE 2000ML ANTI-REFLUX LIF ( I ) TRAY SBS ( I ) WRAPPER 24" X 24" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2415 ,1 lots 140412654 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices EAR PACK CONTENTS: (I) CAUTERY PENC IL ROCKER SW I TI-I CH ( I ) EMESIS BASIN l Oin 700cc (2) LABEL FOR SKIN MARKERS ( I) NEEDLE HYPODERMIC 1 80 X I Y, ( I) WASI-l BASIN ROUND 6QT (I) INSTRUMENT POUCH 7 X I I 2 COMPART (I) STRIP STER I CLOSURE W' X 4" LIF (I) SYRINGE 3cc W/0 NEEDLE LILOCK L/F (2) SY RI NGE I ML W/0 NEEDLE LILOCK LIF ( I ) CAUTERY POLISHER TI P LIF ( I) SH EET ENT SPLIT 11 0 X 77 (2) LITE GLOVE (2) NEEDLE H YPODERM IC 27G X I \!..'' (1 2) TOWELS CLOTH HUCK (BLUE) ( I ) TUBE SUCTION CONNECT.'!." X 12' L/F ( I ) EAR ULCER SYRINGE 2oz LIF ( I ) TABLE COYER REINFORCED 50" X 90" LIF ( I ) UTILITY BOWL 1 6oz LIF (4) COTrON APPLICATOR 6" WOOD ( I ) INSTRUMENT WIPE I MM 8.25 X 8.25 ( I ) MAYO STAND COYER REINFORCED LIF ( I ) NEEDLE & BLADE COUNTER 20c FOAM/MAG LIF ( I ) SKIN MARK ER W/R ULER ( I ) SYRINGE IOcc W/0 NEEDLE LILOCK LIF ( I ) TRAY MAYO SMALL ( I ) SYRING E IOcc TI P CONTROL LILOCK LIF ( I ) DRAPE MICROSCOPE ZEI SS ( I ) TOWELS ABSORBENT 1 5'' X 20" LIF ( I ) TIME OUT BEACON NON WOV EN ST LIF ( I ) BLADE M INUATURE CARBON STEEL ( I 0) GAUZE SPONGE 4" X 4" 1 6PLY XRD LIF ( I ) NEEDLE BLUNT FI LL 1 80 X I Y, (2) SCALPEL SAFETY WEIGHTED # 1 5 ( I ) GOWN SURG, I MP ER. M I CROCOOL LG E (2) GOWN XL SURG ICAL MICROCOOL ( I ) MERLINO SKIN PREP APPLIC. 39ML LIF ( I ) WRAPPER 24" X 24" WET SKIN PACK CONTA INING: ( I ) WRAPPER 30" X 30" ( I ) TRAY 3/COMPARTM ENT ( I ) PYP SCRUB SOLUTI ON 4oz. BOTrLE (3) TI P ABSORBENT APPLICATOR STICK SPONGE (3) TOWELS ABSORBENT 15" X 20" L/F (6) SPONGE WING SMALL LIF (2) GLOVE MED FREETOUCI-1 VYN I L P/F (2) COTrON APPLICATOR 6" WOOD Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2423 ,3 lots 131010019 140111210 140312131 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices EXTREMITY ARM PACK CONTENTS: (1) STOCKINETTE IMPERVIOUS 14" X 48" (1) GOBAN SELF-ADHERENT WRAP 6" X 5yds (3) BANDAGE ELASTIC 4" X 5yds (1) BANDAGE ESMARK 6" X 9 (1) UTILITY BOWL QUART 32oz (10) GAUZE SPONGE 4" X 4" 16PLY (1) TUBE SUCTION CONNECTX 12' (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER (3) SCALPEL WITH HANDLE# 15 STAINLESS STEEL (1) TIME OUT BEACON NON WOVEN (1) LIGHT SHIELD (1) DRAPE INCISE ANTIMICROBIAL 23" X 17" (2) NEEDLE & BLADE COUNTER 10c MAG/CLEAR (1) U-DRAPE 60"X 70" WITH TAPE SPLIT 6" X 21" (1) NEEDLE SPINAL ANESTH 18G X 3% (3) GOWN X-LARGE IMPERVIOUS REINFORCED (1) MAYO STAND COVER REINFORCED (4) DR APE UTILITY WITH TAPE (6) TOWEL ABSORBENT 15" X 20" (3) DRAPE % ECONOMY 53" X 77" (1) YANKAUER OPEN TIP CLEAR W/0 CN (1) CAUTERY TIP POLISHER (1) SUTURE BAG FLORAL (1) GOWN SURG REINFORCED X-LARGE TOWEL & WRAP (1) MERLING SKIN PREP APPLICATOR 39ML (1) SHEET HAND 146" X 104" X 91" (1) TABLE COVER REINFORCED 50" X 90" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2438 ,4 lots 140211465 140211702 140412558 140512912 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices CENTRAL LINE DRAPE PACK 1) MASK PROCEDUAL EAR LOOP 120MM HG V/B L/Free (1) DRAPE SHEET 41" X 58" SMS L/Free (1) CAP NURSE 21" GREEN BOUFFANT (1) DRAPE BRACHIAL ANGlO 44" X 31" REINFORCED CIRC/ FENE (1) WRAPPER 24" X 24" GOWN LGE STANDARD SMS VELCRO NECK TOWELS ABSORBENT 15" X 20" L/Free Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2455 ,6 lots 111123428 112010145 112020523 112030832 112041305 112051957 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices KNEE ARTHROSCOPY PACK 4 CUSTOMED CONTENTS: (1) COVER TABLE REINFORCED 50" X 90" (1) GOWN SURG REINFORCED LARGE TOWEL WRAP AAMI LEVEL Ill (1) PRE PAD CUFF (1) COVER MAYO STAND REINFORCED (1) BAG SUTURE FLORAL (1) SHEET SPLIT WITH/ADHESIVE 108" X 77" STD SMS (1) STOCKINETTE IMPERVIOUS 12" X 48" (4) STRIPS TAPE 24" X 4" (1) DRAPE ARTHROSCOPY W/POUCH (1) TOWEL ABSORBENT 15" X 20" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2463 ,1 lot 113078520 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices 08 PAD PACK II (2,3) CUSTOMED CONTENTS: (3) TOWEL ABSORBENT 15" X 20" (1) BOWL W/LID PLASTIC 80oz (1) GOWN XL SMS IMPERVIOUS REINFORCED (1) SHEET PLASTIC 44" X 65" (1) DRAPE UNDERBUTTOCK W/POUCH (1) UMBILICAL CORD CLAMP (1) BABY BLANKET 30" X 30" POLY ABSOR.IMP. (1) PACKING VAGINAL XRD 4" X 36" 8PLY (10) GAUZE SPONGE 4" X 4" 16PLY XRD (1) DRAPE ABDOMINAL WITAPE 40" X 54" (2) LEGGINS W/7'' CUFF 30" X 42" (1) TABLE COVER REINFORCED 44" X 78" (2) PAD OBSTETRICAL XL (1) EAR ULCER SYRINGE 2oz. Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2464 ,3 lots 112020343 112051958 112083317 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices BASIC PACK IV (6) CUSTOMED CONTENTS: (3) TOWELS ABSORBENT 15" X 20" (1) MAYO STAN COVER REINFORCED (1) DRAPE % ECONOMY 53" X 77" (1) DRAPE SHEET 41" X 58" SMS (4) UTILITY DRAPE W/TAPE (1) SUTURE BAG FLORAL (1) TABLE COVER REINFORCED 44" X 78" (2) GOWN SOFT SMS STD, XLGE SET IN SLEEVE Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2469 ,3 lots 112020350 112052029 112072722 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices BASIC PACK 1 (Ill) CUSTOMED CONTENTS: (1) TABLE COVER REINFORCED 44" X 78" (4) DRAPE UTILITY WffAPE (2) TOWELS ABSORBENT 15" X 20" (1) SUTURE BAG FLORAL (1) DRAPE SHEET 42" X 57" SMS (1) SHEET :X 57" X 63" REINFORCED SMS (1) MAYO STAND COVER REINFORCED Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2471 ,5 lots 112041034 112051959 112072723 113078521 140513219 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices ARTHROSCOPY PACK I (1) CUSTOMED CONTENTS: (1) TOWELS ABSORBENT 15" X 20" (1) GOWN XL SMS IMPERVIOUS REINFORCED (1) MAYO STAND COVER REINFORCED (1) U - DRAPE 60" X 70" WITAPE SPLIT 6 X 21 (1) SHEET SPLIT W/ADHESIVE 108" X 77" STD SMS (1) STOCKINETTE IMPERVIOUS 12" X 48" (4) STRIPS TAPE 24" X 4" (1) SUTURE BAG FLORAL (1) SHEET ARTHROSCOPY T STD SMS W/ POUCH (1) TABLE COVER REINFORCED 44" X 78" (1) GOWN SURG. REINFORCED XLGE TOWEL I WRAP Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2473 ,4 lots 112020354 112051960 112072724 113057469 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices C - BIRTH PACK II {2) CUSTOMED CONTENT: (1) GOWN SURGEON REINFORCED XLGE TOWEL/WRAP LIF (4) TOWEL ABSORBENT 15" X 20" LIF (2) GOWN XLGE SMS IMPERVIOUS REINFORCED LIF (1) COVER MAYO STAND REINFORCED LIF (1) BLANKET BABY 30" X 30" POLYABS IMPERVIOUS LIF (1) SYRINGE EAR/ULCER 2oz LIF (2) PAD OBSTETRICAL X-LARGE (1) BOWL WITH/LID PLASTICS 80oz LIF (1) CLAMP UMBILICAL CORD LIF (1) BAG SUTURE FLORAL LIF (1) DRAPE C-SECTION W/POUCH 102" X 121" X 78" LIF (1) COVER TABLE REINFORCED 50" X 90" LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2476 ,3 lot 112020348 112051961 112072725 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices MINOR EXTREMITY PACK {2) CUSTOMED CONTENT: (1) GOWN LGE STD SMS VELC/NE T/WRAP (1) TOWELS ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) SHEET PLASTIC 44" X 65" (1) DRAPE% ECONOMY 53" X 77" (1) DRAPE UTILITY WITH TAPE (1) BAG SUTURE FLORAL (1) SHEET EXTREMITY ABS 125" X 85" SMS (1) TABLE COVER REINFORCED 50" X 90" (1) GOWN XL SMS IMPERVIOUS REINFORCED Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2477 ,1 lots 112104281 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices CYSTOSCOPY PACK Ill (1) (2) CUSTOMED CONTENTS: (1) TABLE COVER REINFORCED 44" X 78" (2) TOWELS ABSORBENT 15" X 20" (2) LEGGINGS W/7" CUFF 30" X 42" (1) DRAPE CYSTOSCOPY T 60" X 87" 35" SMS STD (1) GOWN SURG.REINFORCED XL EXTRA LONG LEVEL IV Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2482 ,2 lots 112072726 113078522 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices LAPAROSCOPY ABO PACK (1) (2) CUSTOMED CONTENTS: (1) GOWN SURG. REINFORCED X-LARGE TOWEL I WRAP (2) TOWELS ABSORBENT 15" X 20" (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED (1) MAYO STAND COVER REINFORCED (4) DRAPE UTILITY WITH TAPE (1) SUTURE BAG FLORAL (1) DRAPE LAPAROSCOPY CHOLE W/TROU (1) TABLE COVER REINFORCED 50" X 90" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2483 ,5 lots 112020352 112051963 112072727 113078523 140513401 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices LAPAROSCOPY PACK I (4) CUSTOMED CONTENTS: (1) TOWEL ABSORBENT 15" X 20" LIF (2) LEGGINGS W/7'' CUFF 30" X 42" LIF (1) DRAPE UTILITY WITAPE L/F (1) SUTURE BAG FLORAL LIF (1) SHEET T LAPAROSCOPY SOFT 97" X 96" X 36 LIF" (1) TABLE COVER REINFORCED 44" X 78" L/F Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2485 ,2 lots 112051964 113078524 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices LAPAROTOMY PACK 1 (2&3) CUSTOMED CONTENT: (2) TOWEL ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (4) DRAPE UTILITY WITHffAPE (1) SUTURE BAG FLORAL (1) DRAPE T LAPAROT 102" X 78" X 121" STD SMS (1) TABLE COVER REINFORCED 50" X 90" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2490 ,3 lots 112020346 112051965 112072728 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices TRANSVERSE LAPAROTOMY PACK (8) CUSTOMED CONTENT: (1) TOWEL ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (4) DRAPE UTILITY WITHffAPE (1) SUTURE BAG FLORAL (1) DRAPE LAP TRANSVERSE (1) TABLE COVER REINFORCED 50" X 90" (1) GOWN SURG. REINFORCED XLGE TOWEL & WRAP (1) GOWN XL SMS IMPERVIOUS REINFORCED Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2491 , 4 lots 112031036 112072729 113078526 140513220 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices LAPAROTOMY PACK Ill (4) CUSTOMED CONTENT: (4) TOWEL ABSORBENT 15" X 20" (2) GOWN XLARGE SMS IMPERVIOUS REINFORCED (1) COVER MAYO STAND REINFORCED (2) DRAPE SHEET 41" X 58" SMS (4) DRAPE UTILITY WITH TAPE (1) BAG SUTURE FLORAL (1) DRAPE T LAPAROTOMY 102" X 78" X 121" STD SMS (1) TABLE COVER REINFORCED 50" X 90" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2492 , 12 lots 112020347 112051967 112072730 113099518 131110113 131110247 131110500 131211018 140211827 140312132 140412656 140513131 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices EENT PACK I CUSTOMED CONTENT: (2) TOWEL ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) BAG SUTURE FLORAL (1) SHEET ENT SPLIT 110" X 77" SMS (1) TABLE COVER REINFORCED 50" X 90" (1) DRAPE HEAD W!TAPE 44" X 26" (1) GOWN SURG. REINFORCED XLGE TOWEL/WRAP Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2498 , 4 lots 112020356 112051968 112072870 113078527 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices ORTHOPEDIC PACK I (2) CUSTOMED, 900-2503, contains: (2) TOWELS ABSORBENT 15" X 20" LIF (1) COVER MAYO STAND REINFORCED L/F ( 1) U- DRAPE 60" X 70" W/TAPE SPLIT 6 X 21LIF (1) DRAPE % ECONOMY 53" X 77" LIF (4) DRAPE UTILITY WIT APE LIF (1) BAG SUTURE FLORAL LIF (1) SHEET SPLIT W/ADHES 1 08" X 77" LIF (1) COVER TABLE REINFORCED 50" X 90" LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2503, 3 lots 112051970 112072732 113078528 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices ORTHOPEDIC PACK Ill (1) CUSTOMED CONTENTS: (1) GOWN XL SMS IMPERVIOUS REINFORCED (4) DRAPE UTILITY WffAPE (1) MAYO STAND COVER REINFORCED (1) SUTURE BAG FLORAL (1) DRAPE TOP W/ADHESIVE 108" X 50" STD SMS (1) DRAPE ORTHOPEDIC SPLIT (1) U- DRAPE 60" X 70" WffAPE SPLIT 6 X 21 (1) TABLE COVER REINFORCED 50" X 90" (1) GOWN SURG REINFORCED XLGE TOWEL I WRAP (1) STOCKINETIE IMPERVIOUS 12" X 48" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2499 , 4 lots 112020344 112051969 112072731 113057470 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Urology Pack, 900-2510, package contains: (2) TOWELS ABSORBENT 15X 20 UF (1) DRAPE LITHO 11 0" X 63" W/LEGG/POUCH FEN UF (10)GAUZE SPONGE 4" X 4" 12PL Y (1) GOWN XL SMS IMPERVIOUS REINFORCED UF (1) TUR Y SET 81 " 2.1M REGULAR CLAM (1) GOWN SURG REINFORCED LGE TOWEL & WRAP (1) TUBE SUCTION CONNE 1/4 X 12' UF (3) GEL SYRINGE 10cc PREFILLED (1) TABLE COVER REINFORCED 44 X 78 (1) SYRINGE 60ML LUER LOCK W/O NDL UF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2510, 10 lots: 113046981 113057471 113078312 113088798 113099429 131110251 131210649 140111211 140312133 140412657 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Minor Pack 900-2511, pack contains: (1) GOWN XLGE SMS IMPERVIOUS REINFORCED AAMIIII (10) GAUZE SPONGE 4" X 4" 16PLY XRD (5) LAP SPONGE PREWASH 18" X 18" XRD (1) DRAPE LAPAROTOMY W/POUCH 100" x 72" x 124" (4) DRAPE UTILITY WITH TAPE (2) DRAPE SHEET 41" X 69" MEDIUM ( 1) MAYO STAND COVER REINFORCED ( 1) GOWN SURG XLGE REINFORCED TOWEL & WRAP AAMIIII ( 1) BLADE SURGICAL STAINLESS STEEL# 10 (2) LIGHT SHIELD ( 1) CAUTERY PENCIL ROCKER SWITCH ( 1) TABLE COVER REINFORCED 50" X 90" ( 1) UTILITY BOWL BLUE 16oz ( 1) TOWELS ABSORBENT 15" X 20" ( 1) SOLUTION SURGICAL DURAPREP 6ML Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2511, 10 lots: 112083072 113099519 113109796 131110292 131210659 140111323 140211706 140211936 140412903 140513479 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Laparotomy Pack, 900-2516, pack contains: ( I) TABLE COVER44" X 90" ( I) CAUTERY PENCIL PUSH BOTTOM (4) TOWELS ABSORBENT 15" X 20" L/F ( I) BULB SYRINGE 60cc LIF (4) DRAPE UTILITY WIT APE LIF (I) SKIN MARKER W/RULER ( I) SUTURE BAG FLORAL LIF ( I) Y ANKAUER SUCTION TUBE W/0 VENT LIF (2) COUNTER NDL /BLADE IOc MAG/CLEAR ( I) GOWN XL SMS IMPERV. REINFORCED LIF (5) LAP SPONGE PREWASH 18" X 18" XRD LIF ( I) GOWN SURG REINFORCED. LGE T/WRAP LIF ( I) TUBE SUCTION CONNECT W' X 12' LIF (2) LITE GLOVE LIF ( 10) GAUZE SPONGE4" X 4" 16PLY XRD LIF (2) DRAPE SHEET 41" X 58" SMS LIF ( I) CAUTERY TIP POLISHER LIF ( I) MERLING SKIN PREP APPLIC. 39ML LIF ( I) UTILITY BOWL PINT 16oz LIF ( I) SKIN STAPLE 35 WIDE LIF ( I) UTILITY BOWL QUART 32oz LIF ( I) BLADE SURGICAL II CARBON STEEL ( I) TRAY MAYO SMALL ( I) BLADE SURGICAL 20 CARBON STEEL ( I) MAYO STAND COVER REINFORCED LIF ( I) DRAPE LAPAROTOMY 100" X 72" X 124" W/POUCH Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2516, 2 lots: 131110250 131210792 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Gown Cool Impervious XLGE Breathable Customed, 900-2592: (1) GOWN XL SURGICAL MICROCOOL (1) WRAPPER 24" X 24" (1) TOWELS ABSORBENT 15" X 20" LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2592, 20 lot: 112020341 112041064 112041312 112051974 112062485 112062496 112124666 112125076 113057401 113067920 113078313 113088800 113089085 113099304 113109818 131110252 131210794 140111212 140312135 140412659 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Arthroscopy Pack,900-2609, contains: (5) LAP SPONGE PREWASH 18" X 18" XRD (1) SHEET ARTHROSCOPY T STD SMS WITH POUCH (3) STRIPS TAPE 24" X 4" (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (4) TOWELS ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) TUBE SUCTION CONNECT Y4" X 12' (2) ELASTIC BANDAGE WITH VELCRO 6" X 5yds (10) GAUZE SPONGE 4" X 4" 16PLY XRD (1) MERLING SKIN PREP. APPLIC 39ML (1) CAST PADDING COTTON ROLL 2" X 4yds (1) SKIN MARKER WITH RULER (1) BLADE SURGICAL# 11 CARBON STEEL (1) GOWN SURG REINFORCED LGE TOWEL WRAP (2) GOWN XL SMS IMPERVIOUS REINFORCED (2) LITE GLOVE (1) STOCKINETTE IMPERVIOUS 12" X 48" (1) TABLE COVER REINFORCED 50" X 90" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2609, 7 lots: 131210795 140111213 140211829 140312136 140412660 140513133 140513402 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Hip & Knee replacement pack, 900-2614, contains (1) CAUTERY TIP POLISHER UF (1) BAG SUTURE FLORAL (1) TUBE SUCTION CONNECT Y." X 12' UF (1) TABLE COVER REINFORCED 50" X 90" UF (1) MAYO STAND COVER REINFORCED UF (5) TOWELS ABSORBENT 15" X 20" UF (2) DRAPE SHEET 70" X 100" L/F (5) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) SKIN STAPLE 35 WIDE LIF (1) MAYO TRAY LARGE (1) TOP DRAPE WITH ADHESIVE 100" X 50" SMS STD L/F (1) BULB SYRINGE 60cc (1) UTILITY BOWL 16oz (1) UTILITY BOWL QUART 32oz (1) INCISION DRAPE 23" X 17" (1) SKIN MARKER WITH RULER (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6 X 21 (1) YANKAUER SUCTION TUBE WITHOUT VENT UF (1) MERLING SKIN PREP APPLIC. 39ML UF (1) BLADE SURGICAL# 10 STAINLESS STEEL (1) SHEET SPLIT WITH ADHESIVE 108" X 77" UF (1) *GLOVE# 7.5 SURGEON NEUTRALON LATEX (1) * GLOVE # 8 SURGEON NEUTRALON LATEX (1) *GLOVE# 8.5 SURGEON NEUTRALON LATEX (3) GOWN IMPERVIOUS EXTRA REINFORCED XL LIF (1) GOWN IMPERVIOUS EXTRA REINFORCED LARGE TOWEL & WRAP (4) UTILITY DRAPE WITH TAPE UF (1 0) GAUZE SPONGE 4" X4" 16PL Y XRD LIF (2) BANDAGE ELASTIC WITH VELCRO 6" X 5yds (1) BLADE SURGICAL# 20 STAINLESS STEEL (2) LITE GLOVE UF (1) STOCKINETIE IMPERVIOUS 12" X 48" (1) CAUTERY PENCIL ROCKER SWITCH UF (1) BANDAGE ESMARK 6" X 9yds UF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product code 900-2614, 1 lot: 140312137 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Extremity Pack, code 900-2615, contains: (5) LAP SPONGE PREWASH 18" X 18" XRD (1) ELASTIC BANDAGE WITH VELCRO 4 X 5 (2) BLADE SURGICAL# 15 STAINLES STEEL (4) DRAPE UTILITY WITH TAPE (1) GOWN XL SMS IMPERVIOUS REINFORCED ( 1) GOWN SURG REINFORCED LARGE TOWEL & WRAP (1) SKIN MARKER WITH RULER (1) TUBE SUCTION CONNECT Y4" X 12' ( 1) CAST PADDING SOFT ROLL 4" X 4yds (10) GAUZE SPONGE 4" X 4" 16PLY ( 1) MERLING SKIN PREP APPLIC 39ML (1) MAYO STAND COVER REINFORCED ( 1) TABLE COVER REINFORCED 50" X 90" (2) DRAPE SHEET 42" X 55" ( 1) STOCKINETTE 9" x 48" (1) CAUTERY PENCIL ROCKER SWITCH (2) LITE GLOVE ( 1) BANDAGE ESMARK 6" X 9yds ( 1) SHEET EXTREMITY ABS SMS 125" X 85" ( 1) UTILITY BOWL QUART 32oz Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. 900-2615, 6 lots: 113099520 131110253 131210797 140211867 140312138 140412662 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Shoulder Pack, Code 900-2616, contains: (2) TUBE SUCTION CONNECT Y."X12' UF (1) SYRINGE 20CC W/0 NDL UL UF (2) DRAPE VIDEO CAMERA UF (1) COVER MAYO STAND REINF. UF (5) SPONGE LAP. PRE-WASH XRD UF (1) DRAPE U 60" X 70" WIT APE UF (1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD UF (1) DRAPE BEACH CHAIR SHOULDER UF (1) CO BAN WRAP 4"X5 YRD LATEX (1) GOWN IMP. XTRA REINF. X-LGE UF (1) TUR Y SET 81" 2.1M REG. CLAM (1) GOWN IMP. POL YREINF XLGE T/WRAP UF (1) TABLE COVER REINF. 50" X 90" UF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. 900-2616, 4 lots: 112083077 113109907 131110339 140312139 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Open Heart Pack, code 900-2618, contains: (9) DRAPE 60" X 76" REINFORCED LIF ( 1) MAYO STAND COVER REINFORCED LIF (6) TOWELS ABSORBENT 15" X 20" L/F ( 1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE LIF ( 1) MAYO TRAY LARGE (8) DRAPE UTILITY WfTAPE LIF (1 ) TABLE COVER REINFORCED 44" X 78" LIF (2) GOWN SURG. SMS POLY-REINF BREATHABLE AAMI IV X-LARGE T/WRAP ( 1) DRAPE SPLIT CARDIO W/CLEAR ANEST. SC STD SMS ( 1) SHEET SPLIT BILATERAL 84" X 80" LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. 900-2618, 7 lots: 113078598 113099489 113109819 131110407 140211729 140412561 140513137 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices LAP Abdom w/pouch Customed code 900-2619, contains: (1) DRAPE LAP. ABDOM W/POUCH 102" X 122" X 78" (1) WRAPPER 30" X 30" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. 900-2619, 2 lots: 131211019 140312150 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices HIP PACK I (2), CUSTOMED, code 900-2504 (1) GOWN SURG. REINFORCED XLGE TOWEL/WRAP (1) MAYO STAND COVER REINFORCED (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (1) STOCKINETTE IMPERVIOUS 12" X 48" (4) DRAPE UTILITY WITH TAPE (1) BAG SUTURE FLORAL (1) DRAPE HIP 89" X 128" REINFORCED WITH ADHESIVE (1) COVER TABLE REINFORCED 50" X 90" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. 900-2504, 4 lots: 112020358 112052030 112072733 113078529 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Universal Pack II (2) Customed 900-2509 (1) MAYO STAND COVER REINFORCED (2) DRAPE SIDE 42" X 76" WITH TAPE (1) DRAPE BOTTOM ABSORBENT REINFORCED 71" X 62" STD SMS WITH TAPE (1) DRAPE TOP W/ADHESIVE 1 08" X 50" STD SMS (1) SUTURE BAG FLORAL (1) TABLE COVER REINFORCED 50" X 90" (1) GOWN SURG. REINFORCED XLGE TOWEL I WRAP Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. 900-2509, 3 lots: 112020357 112051971 113078530 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Shoulder pack (I) (2), code 900-2515 (1) GOWN IMP. XTRA REINF. XL TOWEL WRAP LEVEL Ill (1) TOWEL ABSORBENT 15" X 20" (1) GOWN XXL SMS IMPERVIOUS REINFORCED (1) MAYO STAND COVER REINFORCED (2) STRIPS TAPE 24" X 4" (1) SUTURE BAG FLORAL (1) SHEET SPLIT W/ADHESIVE 1 08" X 77" STD SMS (1) DRAPE SHOULDER SPLIT W/ADHESIVE (1) TABLE COVER REINFORCED 50" X 90" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. 900-2515, 2 lots: 112104283 113078531 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Plastic Pack Customed, code 900-2582 (1) GOWN LGE SMS IMP REINF L/F (1) GOWN SURG. REINF LGE TMJRAP LIF (1) MAYO STAND COVER REINF LIF (1) TABLE COVER REINF 50" X 90" LIF (4) (1) PVP PAINT 8" STICK SPONGE (2) DRAPESHEET 41X A쳌MED LIF (3) TOWELS ABSORBENT 15 X 20 LIF (2)DRAPE UTILITY Rape LIF (1) BLADE SURGICAL15 S/STEEL (10) GAUZE SPONGE 4 X 4 16 PL Y (20) APPLICATOR COTOIN 6 WOOD Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. 900-2582, 2 lots: 112030835 112041310 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Face Pack MRT, product code 900-2654, contains: (2) GOWN SOFT SMS STD X-LARGE SET IN SLEEVE LIF (2) TOWELS ABSORBENT 15 X 20 LIF (1) DRAPE INST. MAGNETIC 10 X 16 LIF (1) TRAY HALF DEEP (1) COVER MAYO STAND REINFORCED LIF (1) SHEET ENT SPLIT 110 X 77 SMS LIF (1) COVER TABLE REINFORCED 44" X 78" LIF (20) GAUZE SPONGES 4 X 4 12PLY L/F (6) TOWELS CLOTH HUCK C BLUE L/F (2) TIP ABSORB. APPLIC STICK SPONGE LIF (1) STRIP STERI CLOSURE LIF (1) CUP DENTURE 8oz. TEAL WITH LID (1) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER LIF (2) SYRINGE 10ML DARK GREEN (1) SYRINGE 10ML YELLOW L/F (1) LITE GLOVE LIF (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. 900-2654, 2 lots: 112062214 112093599 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Liposuction Pack MRT, code 900-2656, contains: (1) NEEDLE HYPODERMIC 27 X 1 LIF (1) UTILITY BOWL QUART 32oz LIF (1) MAYO STAND COVER REINFORCED LIF (2) GOWN SOFT SMS STD X-LARGE SET IN SLEEVE LIF ( 1) PVP SCRUB SOLUTION 4oz BOTTLE (20) GAUZE SPONGES 4 X 4 (12) TOWEL CLOTH HUCK (BLUE) (4) TOWEL CLAMP (3) TIP ABSORBENT APPLICATOR STICK SPONGE LIF ( 1) SAFETY SCALPEL 15 (3) DRAPE SHEET 70 X 100 LIF (2) TOWEL ABSORBENT 15 X 20 LIF (2) TABLE COVER REINFORCED 44 X 78 LIF (1) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER LIF (1) DENTURE CUP 8oz WITH LID (2) SYRINGE 10ML W/FIXED M/L DARK GREEN (1) TUBING INFILTRATION PERISTALTIC PUMPS (2) LITE GLOVES L/F Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Code 900-2656, 1 lot: 140111441 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Tummy Pack MRT, code 900-2657, contains: (2) GOWN SOFT SMS STD XLGE SET IN SLEEVE ( 1) CAUTERY PENCIL PUSH BOTTOM ( 1) NEEDLE ULTRACLEAN 1" (2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK ( 1) NEEDLE & BLADE COUNTER 20c FOAM/MAG ( 1) BOWL UTILITY QUART 32oz (1 ) MAYO STAND COVER REINFORCED (1 ) TABLE COVER REINFORCED 50" X 90" (1 ) DRAPEBREASTICHEST SMS ( 1) RULER 6" CLEAR (6) TOWEL CLOTH HUCK C (BLUE) (2) TOWELS ABSORBENT 15" X 20" ( 1) TUBE SUCTION CONNECT ~" X 12' ( 1) DENTURE CUP 8oz WITH LID (2) SKIN MARKER INK WITH 8 LABEL (2) LITE GLOVES Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Code 900-2657, 3 lots: 112062216 112093596 112093902 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Breast Pack MRT, code 900-2658, contains: ( 1) BULB SYRINGE 60cc (2) GOWN SOFT SMS STD XLGE SET IN SLEEVE ( 1) CAUTERY PENCIL PUSH BOTTOM (2) SYRINGE 10cc W/0 NEEDLE LUER LOCK ( 1) NEEDLE and BLADE COUNTER 20c FOAM/MAG ( 1) UTILITY BOWL QUART 32oz ( 1) MAYO STAND COVER REINFORCED ( 1) TABLE COVER REINFORCED 50 X 90 ( 1) DRAPE BREAST/CHEST SMS ( 1) YANKAUER SUCTION TUBE W/0 VENT ( 1) TUBE SUCTION CONNECT Y ( 1) RULER 6 CLEAR (6) TOWEL CLOTH HUCK C (BLUE) (2) TOWEL ABSORBENT 15 X 20 (2) SKIN MARKER INK W/ LABEL ( 1) DENTURE CUP 8oz W/LID (2) LITE GLOVES Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Code 900-2658, 3 lots 112062217 112093595 112093720 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Breast Implant Pack, Code 900-2660, contains: (1) DRAPE ECONOMY 53 X 77 (3) GOWN SOFT SMS STANDARD XLGE SET IN SLEEVE (3) TOWELS ABSORBENT 15 X 20 (1) MAYO STAND COVER REINFORCED (2) TABLE COVER REINFORCED 50 X 90 (1) SUTURE BAG FLORAL (1) TUBE SUCTION CONNECT Y (6) TOWEL CLOTH HUCK BLUE (4) PAD ABDOMINAL 8 X 7.5 (2) LITE GLOVES (1) CAUTERY TIP POLISHER LIF (1) BLADE SURGICAL CARBON STEEL 15 (1) YANKAUER SUCTION TUBE W/0 VENT (1 0) LAP SPONGE PREWASH 18 X 18 XRD (1) CAUTERY PENCIL ROCKER SWITCH W/HOLSTER (1) UNDERPAD 23 X 36 Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Code 900-2660, 2 lots: 112062218 112093621 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Tummy Tuck and Liposuction Pack, code 900-2661, contains: ( 1) DRAPE % ECONOMY 53 X 77 (3) GOWN SOFT SMS STANDARD X-LARGE SET IN SLEEVE (3) TOWELS ABSORBENT 15 X 20 (1) MAYO STAND COVER REINFORCED (1) TABLE COVER REINFORCED 50 X 90 ( 1) SUTURE BAG FLORAL (6) TOWEL CLOTH HUCK BLUE (1) BLADE SURGICAL CARBON STEEL 10 (1) BLADE SURGICAL CARBON STEEL 11 (4) PAD ABDOMINAL 8 X 7.5 ( 1) CAUTERY TIP POLISHER (2) LITE GLOVES ( 1) YANKAUER SUCTION TUBE WITHOUT VENT (20) LAP SPONGE PREWASH 18 X 18 XRD (1) CAUTERY PENCIL ROCKER SWITCH WITH HOLSTER (1) UNDERPAD 23 X 36 ( 1) TUBE SUCTION CONNECT 1/4 X 12 (1) DRAPE BREAST/CHEST SMS Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Code 900-2661, 1 lot: 140312417 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Liposuction Pack, code 900-2681, contains: (3) GOWN SOFT SMS STD XLGE SET IN SLEEVE (1) TUBE SUCTION CONNECT (1) MAYO STAND COVER REINFORCED (1) SKIN MARKER INK W LABEL (2) TABLE COVER REINFORCED 50 X 90 (1) RULER 6 CLEAR (12) TOWELS CLOTH HUCK (BLUE) (1 0) LAP SPONGE PREWASH 18 X 18 XRD (1) CAUTERY TIP POLISHER (20) GAUZE SPONGE 4X 4 12PL Y (4) TOWEL CLAMP (1) Y CONNECTOR (1) CAUTERY PENCIL PUSH BOTTOM (3) DRAPE SHEET 98 X 63 STD SMS Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Code 900-2681, 1 lot: 112093711 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Breast Augmentation Pack, Imagenes Cosmetic, code 900-2682: (3) GOWN SOFT SMS STD XLGE SET IN SLEEVE ( 1) CAUTERY PENCIL PUSH BOTTOM ( 1) TUBE SUCTION CONNECT ( 1) MAYO STAND COVER REINFORCED ( 1) SKIN MARKER INK W LABEL (2) TABLE COVER REINFORCED 50 X 90 ( 1) RULER 6 CLEAR (6) TOWEL CLOTH HUCK (BLUE) (10) LAP SPONGE PREWASH 18 X 18 XRD ( 1) CAUTERY TIP POLISHER ( 1) YANKAUER SUCTION TUBE W/O VENT ( 1) DRAPE BREAST/CHEST SMS Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Code 900-2682, 1 lot: 112093710 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Tummy Tuck Pack, code 900-2684, contains: (3) GOWN SOFT SMS STD XLGE SET IN SLEEVE ( 1) CAUTERY PENCIL PUSH BOTTOM ( 1) TUBE SUCTION CONNECT ( 1) MAYO STAND COVER REINFORCED ( 1) SKIN MARKER INK W LABEL (2) TABLE COVER REINFORCED 50 X 90 ( 1) RULER 6 (6) TOWEL CLOTH HUCK (BLUE) (10) LAP SPONGE PREWASH 18 X 18 XRD ( 1) CAUTERY TIP POLISHER ( 1) DRAPE BREAST/CHEST SMS Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Code 900-2684, 2 lots: 112093646 113057473 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Bandeja para Debridacion, code 900-2702, contains: (1) FORCEP ADSON TISS (20) GAUZE SPONGES 4 X 4 12PL Y (1) SCISSORS IRIS STRAIGHT 4.5 W/PROTECTOR TIP (1) TOWEL 3 PLY POLY 13 X 18 (1) DRAPE 18 X 26 WHITE/WHITE POLYPROPYLENE (1) CHLORASCRUB SWABSTICK 1.6 ML (1) TRAY KUTIER (1) SCALPEL W/HANDLE 20 (1 i WRAPPER 24 X 24 Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Code 900-2702, 4 lots: 131110501 140111072 140211830 140312140 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Endovascular Pack, code 900-2715, contains: ( I) DRAPE FEMORAL ANG. 125 X 75 X 56 WITH POUCH LIF (2) TOWELS ABSORBENT 15 X 20 LIF ( I) CONTAINER SPECIMEN 4oz W/LID & LABEL Llf (2) BAG BAND FLUOROSCOPE 36 X 30 LIF ( I) NEEDLE HYPODERMIC 21G X I Y, LIF (2) GOWN LARGE SMS IMPERVIOUS REINFORCED AAMI III LIF (2) SOLUTION SURGICAL DURAPREP 6ML LIF ( I) BAG BAND RUB BAND & TAPE 42 X 38 LIF (4) TOWELS CLOTH HUCK BLUE LIF (I) Pr. GLOVE SYNTEGRA CR 6.5 POWDER FREE Llf (2) Pr. GLOVE SYNTEGRA CR 8 POWDER FREE LIF ( I) NEEDLE HYPODERMIC 25G X 5/8 LIF ( I) SYRINGE 30CC WITHOUT NEEDLE LUER LOCK LIF (I) COYER TABLE 44 X 90 LIF ( I) SCALPEL WITH HANDLE (25) GAUZE SPONGES 4 X 4 12PLY LIF (2) CLAMP TOWEL (2) SYRINGE I OCC WITHOUT NEEDLE LUER LOCK LIF ( I) NEEDLE HYPODERMIC 18G X I Y, LIF ( I) SHARP STOP NEEDLE HOLDER LIF ( I) TRAY ORGANIZER FULL DEEP ( I) NEEDLE 18G X 23 (I) BOWL UTILITY BLUE 16oz LIF ( I) WRAPPER 24X 24 LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Code 900-2715, 1 lot: 113099591 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Knee Arthroscopy Pack, code 900-2718, contains: (1 0) GAUZE SPONGES 4 X 4 12PL Y (2) PADDING CAST SOFT ROLL 6 X 4yds. (1) GOBAN SELF-ADHERENT WRAP 6 X 5yds (3) PAD ABDOMINAL 8 X 7.5 (1) DRESSING 1 X 8 XEROFORM PETROLAT (10) GAUZE SPONGES 4 X 4 16PLY XRD (3) NEEDLE HYPODERMIC 18G X 1 (1) NEEDLE SPINAL ANESTH 18G X 3 (1) NEEDLE HYPODERMIC 22G X 1 (1) SYRINGE 30cc W/0 NEEDLE LUER LOCK (1) SCALPEL W/HANDLE 11 (1) SKIN MARKER W/RULER (9) LABELS FOR SKIN MARKERS (1) RULER (3) Pr. GLOVESURG 8 DERMA PRENE POWDER FREE (1) BANDAGE ELASTIC KNIT STD 10yds (1) BANDAGE ESMARK 6 X 9yds (8) TOWELS CLOTH HUCK BLUE (1) U - DRAPE 60 X 70 WIT APE SPLIT 6 X 21 (1) SHEET 60 X 77 DRAPE REINFORCED (2) SOLUTION SURGICAL DURAPREP 26ML (3) TUBE SUCTION CONNECT (1) BOWL UTILITY 16oz. (1) COVER TABLE REINFORCED 50 X 90 (2) GOWN SURGICAL REINFORCED X-LARGE (1) GOWN SURGICAL REINFORCED X-LARGE T/WRAP (2) TOWELS ABSORBENT 15X 20 (1) STOCKINETTE IMPERV 12 X 48 (2) BAG PLASTIC 6 X 12 (1) KNEE ARTHROSCOPY DRAPE (1) FILTER STRAW 5 MICRO (2) LITE GLOVE Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Code 900-2718: 3 lots 113026299 113068033 113078728 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Shoulder Arthroscopy Pack, code 900-2719, contains: (1 0) GAUZE SPONGES 4 X 4 12PL Y (1) COBAN WRAP TAN 4 X 5yds (3) PAD ABDOMINAL 8 X 7.5 (1) DRESSING 1 X 8 XEROFORM PETROLAT (1 0) GAUZE SPONGES 4 X 4 16PL Y XRD (1) NEEDLE HYPODERMIC 18G X 1 (1) NEEDLE SPINAL ANESTH 18G X 3 W (1) NEEDLE HYPODERMIC 22G X 1 W (1) SYRINGE 60ML W/O NEEDLE LUER LOCK (1) BLADE SURG. 11 CARBON STEEL (1) SKIN MARKER W/RULER (9) LABELS FOR SKIN MARKERS (4) PR GLOVE SURG. DERMA PRENE POWDER FREE (8) TOWELS CLOTH HUCK BLUE (2) U - DRAPE 60X 70 WIT APE SPLIT 6 X 21 (1) SHEET 60 X 77 DRAPE REINFORCED (2) SOLUTION SURGICAL DURAPREP 26ML (3) TUBE SUCTION CONNECT (1) TABLE COVER REINFORCED 50 X 90 (1) RULER (2) GOWN SURGICAL REINFORCED X-LARGE (1) GOWN SURGICAL RE INFORCED X-LARGE TOWEL/WRAP (2) TOWELS ABSORBENT 15 X 20 (2) BAG PLASTIC 6 X 12 2ml (1) SHOULDER ARTHROSCOPY DRAPE (1) FILTER STRAW 5 MICRO (1) UTILITY BOWL 16oz (1) STOCKINETTE IMPERV 9 X 48 (2) LITE GLOVE Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Code 900-2719: 3 lots 113047020 113068032 113078729 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Gown Surgical Soft SMS Non Reinforced, code 900-2725, contains: (1) GOWN SOFT SMS STD X-LARGE SET IN SLEEVE (1) TOWEL ABSORBENT 15" X 20" (1) WRAPPER 24" X 24" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Code 900-2725: 2 lots 112093989 113057519 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices REEMPLAZO DE RODILLA Y CADERA CONTENTS: (6) TOWELS ABSORBENT 15" X 20" (I) PK. STRIP STERICLOSURE Y," X 4" (I) COVER MAYO STAND RErNFORCED (I) SKIN MARKERINK W/8 LABEIJfiME OUT/RULER (I) BAG SUTURE FLORAL (2) SCALPEL WEIGHTED SAFETY # I0 (I) STOCKrNETTE IMPERV 14" X 48" (I) TIME OUT BEACON NON WOVEN (2) DRAPE U 60" X 70"WI TAPE SPLIT 6" X 21 " (2) TUBE SUCTION CONNECT'/.'' X 12' (2) DRAPE INCISE ANTIMICROBIAL 23" X 17" (2) LIGHT SHIELD (I) NEEDLE SPINAL ANESTH 18G X 3 Y, (4) STR IPS TAPE 24" X 4" (I ) GOWN IMP. XTRA REINF SMS XL T/W LEVEL (20)GAUZE SPONGES 4" X 4" 16PLY (3) DRAPE '!. ECONOMY 53" X 77" (I) DRAPE UNDERBUTTOCK W/POUCI-1 44" X 35" (I) DRAPE TOP WIADHESIVE 108" X 50" STD SMS (I) COUNTER NEEDLE 60C FOAM STRIP/MAG STRIP (I) YANKAUER OPEN TIP CLEAR W/0 CIV (2) DRAPE SIDE 36" X 77" W/ADl-1. (I) SHEET SPLIT W/ADHES 108" X 77" STD SMS (I) SYRINGE 60ML UL W/0 NEEDLE (I) POLISHER CAUTERY TIP (I) NEEDLE BLUNT FILL 1 8G X I Y, (2) COVER TABLE BTC 77" X I I 0"l-ID FULL COVERAGE (2) GLOVE SURG. DERMA PRENE #8 POWDER FREE (10) SPONGE LAP PREWASH 18" X 18" XRD (I) COVER MAYO STAND W/CSR 23" X 54" (I) BOWL UTILITY QUART 32oz. (3) CLAMP TOWEL (I) BOWL UTILITY PINT 16oz. (3) GOWN MICROCOOL IMP. XTRA LONG XL (3) BANDAGE ELASTIC 6" X 5YRD WIVELCRO (I) MERLING SKrN PREP APPLIC.39ML (2) PADDING CAST SOFT ROLL 6 X 4YRD (I) MAYO TRAY LARGE Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Code 900-2726: 7 lots 131110255 131210799 140111086 140211664 140312141 140412664 140512992 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices MINOR PACK CONTENTS: (1) TOWELS ABSORBENT 15" X 20" (1) WRAPPER 24" X 24" (16) GAUZE SPONGES 2" X 2" 8PLY (1) TRAY HALF SHALLOW (12) COTION TIP APPLICATOR 6" WOOD (2) GLOVE SKY NITRILE PF BLUE MED (18) GAUZE SPONGES 4" X 4" 12PLY (1) SMALL DRAPE W/ADH APERTURE POUCH Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Code 900-2727: 3 lots 112093757 113025895 113078730 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices NEURO SPINE PACK , CODE 900-2765 CONTENTS: (l ) DRAPE INCISION 23" X 1 7" (I) SCALPEL W/HANDLE # 15 S/STEEL (I) INSTRUMENT POUCH 7 X 1 1 2 COMPART (I) Pk. STRIP SURGICAL W' X 6" (I) CAUTERY PENCIL HAND SWITCHING LIF (4) UTILITY DRAPE W/TAPE L/F (I) SCALPEL W/HANDLE # 10 S/STEEL (I) TUBE SUCTION CONNECT W' X I 2' LIF (I) SKIN MARKER W/RULER (2) SPECIMEN CONTAINER4oz W/LID & LABEL (I) SOLUTION SURGICAL DURAPREP 26ML LIF (I) YANKAUER SUCTION TUBE W/0 VENT LIF (I) MAYO TRAY LARGE (2) NEEDLE & BLADE COUNTER lOc MAG/CLEAR (I) DRAPE INCISE ANTIMICROBIAL 23" X 1 7" LIF (2) SYRINGE I Occ W/0 NEEDLE LUER LOCK LIF (I) J VAC RESERVOIR 300ML (2) LITE GLOVE LIF (2) CAUTERY TIP POLISHER LIF (2) TABLE COVER BTC 77" X 110" HD FULL L/F (20) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (4) TOWELS ABSORBENT 1 5" X 20" LIF ( I ) DRAPE T LAPAROTOMY 102" X 78" X 1 21" STD SMS (5) LAP SPONGE PREWASH 18" X 18" XRD LIF ( I) SUTURE BAG FLORAL (5) DRAPE 'l'4 ECONOMY 53" X 77" LIF (3) GOWN IMPERVIOUS EXTRA REI NF. LGE T/WRAP (I) UTILITY BOWL 1 6oz LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Code 900-2765, 6 lots 112124939 113036441 113056798 113057644 113078320 113088806 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices SHOULDER PACK CODE 900-2766 CONTENTS: (1) STAPLE SKIN 35 WIDE LIF (1) *GOBAN SELF-ADH 4" X 5YD WRAP TAN LATEX (2) U-DRAPE 60" X 70" WITAPE SPLIT 6" X 21" (1) TABLE COVER 44" X 90" (4) TOWELS ABSORBENT 15" X 20" LIF (2) TUBE SUCTION CONNECT" X 12' LIF (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER LIF (1) BAG SUTURE FLORAL (1) SYRINGE 20cc W/0 NEEDLE LUER/LOCK LIF (1) SCALPEL WEIGHTED SAFETY #11 (1) NEEDLE SPINAL ANESTH 18G X 3% LIF (1) DRAPE INCISE ANTIMICROBIAL 23" X 17" LIF (1) CHLORAPREP 26ML APLICATOR TEAL LIF (2) ATTACHABLE POUCH BEACH CHAIR 35" X 43" WITH SUCTION PART (4) DRAPE UTILITY WITAPE L/F (4) STERI-DRAPE SMALL TOWEL DRAPE NPN-STERILE 17" X 11" LIF (1) BOWL UTILITY 32oz. (1) STOCKINETTE 6" X 48" L/F (5) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) WRAPPER 24" X 24" (1) NEEDLE HYPODERMIC 22G X 1 % (1) GOWN SURG REINFORCED X-LARGE TOWEL I WRAP (1) GOWN MICROCOOL IMPERV. EXTRA LONG X-LARGE (2) DRAPE ORTHOPEDIC SPLIT (1) MAYO STAND COVER REINFORCED LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Code 900-2766, 6 lots 113078317 131110257 131210801 140111215 140312143 140412666 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices LAPAROTOMY PACK BASIC CODE 900-2829 CONTENTS: (2) TOWELS ABSORBENT 15" X 20" (1) COVER MAYO STAND REINFORCED (4) DRAPE UTILITY WITH TAPE (1) BAG SUTURE FLORAL (1) DRAPE T LAPAROT 102" X 78" X 121" STD SMS (1) COVER TABLE REINFORCED 50" X 90" (1) GOWN XL SMS IMPERVIOUS REINFORCED AAMI LEVEL Ill (1) TIME OUT BEACON NON WOVEN (1) COUNTER NDUBLADE 20C FOAM/MAG (1) SKIN MARKER INK W/8 LABEUTIME OUT/RULER (1) GOWN IMPERVIOUS EXTRA REINFORCED LARGE TOWEL & WRAP AAMI LEVEL Ill Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Code 900-2829, 4 lots 140111331 140211831 140312145 140412671 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices ORTHOPEDIC PACK BASIC CODE 900-2830. CONTENTS: (3) TOWELS ABSORBENT 15" X 20" (1) COVER MAYO STAND REINFORCED (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6 X 21 SPLIT (1) DRAPE% ECONOMY 53" X 77" (4) DRAPE UTILITY WITH TAPE (1) BAG SUTURE FLORAL (1) SHEET SPLITW/ADHES 108" X 77" STD SMS (1) COVER TABLE REINFORCED 50" X 90" (1) STOCKINETTE IMPERVIOUS 14" X 48" (1) TIME OUT BEACON NON WOVEN (1) GOWN XL SMS IMPERVIOUS REINFORCED AAMI LEVEL Ill (1) POLISHER CAUTERY TIP (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER (1) COUNTER NDLIBLADE 20C FOAM/MAG (1) PENCIL CAUTERY ROCKER SWITCH WITH HOLSTER (1) GOWN IMPERVIOUS EXTRA REINFORCED LGE T/WRAP AAMI LEVEL Il (1) BAG GLASSINE PLAIN (1) ELECTRODE DUAL DEPRES Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Code 900-2830, 3 lots 140111332 140211832 140412672 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices CYSTO TUR PACK BASIC CODE 900-2899. CONTENTS: (2) LEGGINGS W/7'' CUFF 30" X 42" (1) COVER TABLE REINFORCED 44" X 78" (2) TOWELS ABSORBENT 15" X 20" (1) GOWN XLGE SMS IMPERV. REINFORCED AAMI LEVEL Ill (1) TUR CYSTO IRRIGATION SET 79" SINGLE (1) TIME OUT BEACON NON WOVEN ST (1) BAG SUTURE FLORAL (1) UTILITY BOWL 32oz (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER (1) TURP CYSTO DRAPE WITH POUCH (1) GOWN IMPER EXTRA REINF LGE AAMI LEVEL Ill TOWEL & WRAP Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Code 900-2899, 2 lots 140111333 140412673 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices ORTHOPEDIC IMPLANT PACK CUSTOMED USA, CODE 900-2903 CONTENTS: (1) CAUTERY TIP POLISHER UF (1) SKIN MARKER W/RULER (1) BAG SUTURE FLORAL (1) U - DRAPE 60" X 70" WITAPE SPLIT 6" X 21" (1) TUBE SUCTION CONNECT W' X 12' UF (2) PAD ABDOMINAL 8" X 7.5" (1) BAG GLASSINE (1) YANKAUER SUCTION TUBE W/0 VENT LIF (2) LITE GLOVE UF (1) SOLUTION SURGICAL DURAPREP 26ML LIF (2) TABLE COVER REINFORCED 50" X 90" LIF (1) BLADE SURGICAL# 10 STAINLESS STEEL (1) MAYO STAND COVER REINFORCED LIF (1) SHEET SPLIT W/ADHES 108" X 77" STD SMS L/F (5) TOWELS ABSORBENT 15" X 20" UF (1) STOKINETIE IMPERVIOUS 14" X 48" LIF (2) DRAPE SHEET 70" X 100" LIF (1) *GLOVE# 7'!h SURGEON NEUTRALON LATEX (5) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) *GLOVE # 8 SURGEON NEUTRALON LATEX (1) SKIN STAPLE 35 WIDE UF (1) *GLOVE# 8'!h SURGEON NEUTRALON LATEX (1) TRAY MAYO LGE (1) GOWN SURG REINFORCED XL TOWEUWRAP (1) DRAPE TOP W/ADHES 108" X 50" STD SMS UF (2) GOWN XL SMS IMPERVIOUS REINFORCED UF (1) BULB SYRINGE 60cc CLEAR (1) CAUTERY PENCYL ROCKER SWITCH UF (1) UTILITY BOWL 16oz LIF (1) BLADE SURGICAL# 20 STAINLESS STEEL (1) UTILITY BOWL QUART 32oz LIF (4) DRAPE UTILITY WITAPE UF (1) DRAPE INCISION 23" X 17" UF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Code 900-2903, 4 lots 113026303 113057705 113068034 113088858 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices BASIC COSMETIC SURG. PACK CUSTOMED (USA), CODE 900-2915. CONTENTS: (2) TOWELS ABSORBENT 15" X 20" LIF (1) DRAPE BREAST/CHEST SMS L/F (1) SYRINGE 20cc W/0 NEEDLE LUER LOCK LIF (1) TUBE SUCTION CONNECT Yt" X 12' LIF (1) YANKAUER SUCTION TUBE W/0 VENT L/F (1) STERI STRIP CLOSURE%" X 4" L/F (1) BLADE SURG. #15 CARBON STEEL (1) NEEDLE HYPODERMIC 25 X 1 % LIF (5) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) PENCIL CAUTERY ROCKER SWITCH W/ HOLSTER LIF (1) SYRINGE 60cc THUMB CONT. RING CATH. TIP LIF (1) COVER TABLE REINFORCED 50" X 90" LIF (1) COVER MAYO STAND REINFORCED LIF (1) BAG SUTURE FLORAL (2) GOWN SOFT SMS STD. XL SET IN SLEEVE LIF (4) DRAPE UTILITY WITH TAPE L/F (4) TOWEL CLOTH HUCK LIF (1) WRAPPER 24" X 24" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Code 900-2915, 4 lots 113026307 113047021 113068035 113078731 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices ACDFPACK SURGICAL CENTER, CODE 900-2917. CONTENTS: (1) SOLUTION SURGICAL DURAPREP 6ML LIF (4) Prs. GLOVE SURG. DERMA PRENE # 8 PF LIF (3) GOWN SOFT SMS STD XL SET IN SLEEVE LIF (3) TOWELS ABSORBEN 15" X 20" UF (1) TABLE COVER REINFORCED 50" X 90" L/F (1) MAYO STAND COVER REINFORCED LIF (2) DRAPE o/.. 60" X 76" REINFORCED LIF (1)DRAPE THYROID 100" X 142" X 72" LIF (1) FLUORO COVER 30" X 30" W/RUBBAND L/F (1) DRAPE INCISE IOBAN 13" X 13" (2) LITE GLOVE LIF (2) TUBE SUCTION CONNECT. W X 12' LIF (12) TOWELS CLOTH HUCK BLUE LIF (1) UTILITY BOWL 16oz LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (5) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) SKIN MARKER W/RULER LIF (9) LABELS FOR SKIN MARKERS 1.25 X Y:! (1) RULER (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG LIF (2) SYRINGE 20cc W/0 NDL LUER LOCK LIF (2) SYRINGE 3cc W/0 NDL LUER LOCK LIF (1) BULB SYRINGE 60cc LIF (3) NEEDLE HYPODERMIC 18G X 1Y:! LIF (1) NEEDLE 30G X 1 DISP. L/F (1) NEEDLE SPINAL ANESTH 18G X 3W' LIF (2) BLADE SURGICAL# 15 CARBON STEEL (1) TIME OUT BEACON NON WOVEN LIF (2) TAPE TEGADERM 2 3/8 "X 2 o/.. "L/F (2) MEDICINE CUP 2oz LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Code 900-2917, 6 lots 113047022 113057702 113068036 113078732 113109798 140312146 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices TLIF PACK SURGICAL CENTER, CODE 900-2918. CONTENTS: (2) SOLUTION SURGICAL DURAPREP 26ML UF (6) Pr. GLOVE SURG. DERMA PRENE # 8 PF UF (4) GOWN SOFT SMS STD XL SET IN SLEEVE UF (4) TOWELS ABSORBEN 15" X 20" LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) MAYO STAND COVER REINFORCED LIF (4) DRAPE% 60" X 76" REINFORCED L/F (1) DRAPE CHEST 100" X 142" X 72" LIF (1) FLUORO COVER 30" X 30" WITH RUBBBAND LIF (2) LITE GLOVE LIF (2) TUBE SUCTION CONNECT. Y." X 12' UF (12) TOWELS CLOTH HUCK BLUE LIF (1) UTILITY BOWL QUART 32oz (10) GAUZE SPONGE 4" X 4" 16PLY XRD UF (5) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) CAUTERY PENCIL ROCKER SWITCH WITH HOLSTER LIF (1) STERI STRIP DRAPE LARGE 17" X 23" LIF (1) SKIN MARKER WITH RULER UF (9) LABELS FOR SKIN MARKERS 1.25 X Y2 (1) RULER (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG L/F (2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) BULB SYRINGE 60cc LIF (4) NEEDLE HYPODERMIC 18G X 1Y2 UF (1) NEEDLE HYPODERMIC 22G X 1Y2 LIF (2) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK UF (1) NEEDLE SPINAL 18G X 6" LONG LENGTH LIF (1) BLADE SURGICAL # 10 CARBON STEEL (1) BLADE SURGICAL # 15 CARBON STEEL (1) TIME OUT BEACON NON WOVEN UF (2) DRESSING TEGADERM 4" X 4% "UF (2) MEDICINE CUP 2oz (1) DRAPE IOBAN INCISE 2 ANTIMICROBIAL 23" X 23" LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Code 900-2918, 8 lots 113047023 113057703 113068037 113078429 113078733 113109799 140312147 140613795 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Obstetrical Surgical pack, code 900-2940, contains: (1) BLANKET RECEIVING 100 COTTON (3) TOWEL ABSORBENT 15 X 20 LIF (10) GAUZE SPONGE 4 X 4 16PLY XRD LIF (1) SYRINGE EAR/ULCER 2oz. LIF (1) DRAPE ABDOMINAL WITH TAPE 40X54 LIF (2) LEGGINS W/7'' CUFF 30X42 L/F (1) GOWN XL SMS IMPERVIOUS REINFORCED LIF (1) OB PAD WRAP OVERNIGHT (1) TABLE COVER REINFORCED 50X90 LIF (1) DRAPE UNDERBUTTOCK W/POUCH 44X35" (1) CLAMP UMBILICAL CORD LIF (1) BOWL PLASTIC 80oz. LIF (1) LID FOR BOWL 80oz. CLEAR LIF (1) BEANNIES BABY (5) LAP SPONGE PREWASH 18X18XRD (1) MAYO TRAY SMALL (1) DRAPE SHEET 41X58 SMS LIF (1) UNDERPAD 36X36 BEIGE (1) VAGINAL PACKING XRD 4X36 8PLY 100% COTTON (10) GAUZE SPONGE 4X4 16PLY LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Code 900-2940, 1 lot Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Drape Sheet, Product Code 2942, contains (1) DRAPE % ECONOMY 53 X 77L/F (1) WRAPPER 24 X 24 L/F Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Code 900-2942: 113067718 113078516 113088808 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Hair Restoration Pack- , code 900-2966, contains: (1) MAYO STAND COVER 23X54 (2) TOWEL CLOTH HUCK BLUE (2) TABLE COVER BACK ZONE REINFORCED 44 X 90 (2) GOWN SOFT SMS STD. X-LARGE AAMI Ill (2) TOWEL ABSORBENT 15 X 20 (1) MINDE KNIFE 1.0MM, WIDE, 40 DEGREE ANGLE, 6.0MM IN LENGTH Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Code 900-2966, 2 lots: 131210948 140613794 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Basic Pack FPSC Florham Pack , code 900-2969, contains: (1) COVER TABLE REINFORCED 50" X 90" (10) GAUZE SPONGE 4" X 4" 16 PLY XRD (1) COVER MAYO STAND REINFORCED (2) GOWN SOFT SMS STD. X-LARGE AAMI Ill (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG (2) TOWELS ABSORBENT 15" X 20" (4) DRAPE UTILITY WITH TAPE (1) WRAPPER 24" X 24" (8) LABELS FOR SKIN MARKERS 1.25" X %" (2) LITES GLOVE (1) MARKER SKIN WITH RULER (1) BLADE SURGICAL# 15 CARBON STEEL (1) RULER (5) SPONGE LAP PREWASH 18" X 18" XRD Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Code 900-2969: 131110592 131210949 131211012 140111325 140111436 140211730 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Chole Cystectomy All Endo System , code 900-3025, contains: (1) TABLE COVER 44X 90 UF (1) SYRINGE 20ccW/O NDL LUER LOCK LIF (2) MAYO STAND COVER REINFORCED UF (1) NEEDLE HYPODERMIC (6) ABSORBENT TOWEL 15 X 20 UF (1) NEEDLE HYPODERMIC 22G X 1Y. UF (4) UTILITY DRAPE WIT APE UF (1) TROCAR DILATING XCELL 5MM X 100 (3) GOWN XL SURGICAL MICROCOOL L/F (1) TROCAR ENDOPATH XCEL DILATING TIP (1) WRAPPER 24" X 24" UF (1) TUBING INSUFFLATING OPEN TIP W/0 VENT UF (1) DRAPE LAP ABDO. W/POUCH 102 X 122 X 78 STD UF (5) APPLICATOR COTTON 6 WOOD UF (1) ULTRA VERES NEEDLE 120MM LIF (1) APPLIER MUL Tl CLIP W/SHAF GUN (1) SPECIMEN CONTAINER 4oz. W/LID & LABEL UF (2) DRAPE :Y. ECONOMY 53" X 77" UF (2) UTLITY BOWL 16oz. UF (1) SCALPEL WEIGHTED SAFETY #11 UF (1) RING BASIN (1) TIME OUT BEACON NON WOVEN UF (1) TUBE SUCTION CONNECT (1) MERLING SKIN PREP APPLIC 39ML UF (1 0) GAUZE SPONGE 4 X 4 16PL Y XRD LIF (2) TOWEL CLOTH HUCK (BLUE) UF (1 0) GAUZE SPONGE 4 X 4 16PL Y UF (1) SCISSOR CURVED W/MONOPOLAR CAUTERY 5MM (5) LAP SPONGE PRE-WASH 18" X 18" XRD UF (1) DISSECTOR CURVED W/MONOPLAR CAUTERY 5MM (1) SKIN MARKER INK W/8 LABEUTIMEOUT/RULER LIF (2) LIGHT SHIELD UF (1) SUTURE BAG FLORAL UF (4) DRESSING ISLAND 4 X 6 (1) DRAPE LASER CAMERA W/ELASTIC 6X 96 (1) PK. STERI STRIP CLOSURE (1) NEEDLE & BLADE COUNT 60C FOAM STR/MAG STR UF (1) MAYO TRAY SMALL (1) SYRINGE 30ML SLIP TIP 1 ML UF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Code 900-3025, 1 lot: 131110114 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Tummy Tuck Pack-BOD , code 900-3026, contains: (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED AAMIIII (2) TOWELS ABSORBENT 15 X 20 (1) PENCIL CAUTERY PUSH BOTTOM (1) COUNTER NEEDLE/BLADE 20C FOAM/MAG (1) BOWL UTILITY QUART 32oz TURQ (1) COVER MAYO STAND REINFORCED (2) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER (1) COVER TABLE REINFORCED 50 X 90 (1) CUP DENTURE 8oz TEAL WITH LID (1) RULER ACCU-6 (6) TOWELS CLOTH HUCK C BLUE (1) TUBE SUCTION CONNECT (1) DRAPE BREAST/CHEST (2) LITE GLOVE Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Code 900-3026: , 2 lots: 113099551 140312148 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Face Pack- BOD, code 900-3027, contains: (2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill (2) TOWELS ABSORBENT 15" X 20" (1 ) DRAPE INSTRUMENT MAGNETIC 10" X 16" (1 ) TRAY HALF DEEP (1) COUNTER NEEDLE/BLADE 20C FOAM/MAG (1) COVER MAYO STAND REINFORCED (1 ) SHEET ENT SPLIT 110" X 77" (1 ) COVER TABLE REINFORCED 44" X 78" (20) GAUZE SPONGES 4" X 4" 12PLY (6) TOWELS CLOTH HUCK C BLUE (1 ) CUP DENTURE 8oz TEAL WITH LID (1) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER (2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK (2) LITE GLOVE Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. 900-3027, 1 lot: 113099552 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Liposuction Pack BOD, code 900-3028, contains: (2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill (2) LITE GLOVES LIF (2) TOWEL ABSORBENT 15" X 20" L/F (1) NEEDLE HYPODERMIC 27G X 1 %" LIF (1) BOWL UTILITY QUART 32oz TURQ (1) COVER MAYO STAND REINFORCED L/F (1) PVP SCRUB SOLUTION 4oz (2) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER LIF (2) COVER TABLE REINFORCED 44" X 78" LIF (1) CUP DENTURE 8oz TEAL WITH LID (12) TOWEL CLOTH HUCK C BLUE LIF (1) SAFETY SCALPEL #15 DISPOSABLE LIF (2) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK LIF (1) TUBING INFILTRATION PERISTALTIC PUMPS (4) CLAMP TOWEL LIF (3) SHEET DRAPE 70" X 100" LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. 900-3028, 2 lots: 113099553 140613790 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Breast Pack BOD, code 900-3029, contains: (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED AAMI Ill (2) TOWEL ABSORBENT 15" X 20" (1) PENCIL CAUTERY PUSH BOTTOM (1) SYRINGE BULB 60CC (1) TUBE SUCTION CONNECT%" X 12' (1) COUNTER NEEDLE/BLADE 20C FOAM/MAG (1) BOWL UTILITY QUART 32oz TURQ (1) COVER MAYO STAND REINFORCED (1) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER (1) COVER TABLE REINFORCED 50" X 90" (1) CUP DENTURE 8oz TEAL WITH LID (1) RULER (6) TOWEL CLOTH HUCK BLUE (2) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK (1) YANKAUER SUCTION TUBE WITHOUT VENT (1) DRAPE BREAST/CHEST (2) LITE GLOVE Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. 900-3029, 3 lots: 113099554 140312149 140613789 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Face Lift , Code 900-3083, contains: (I) SHEET ENT SPLIT 110" X 77" LIF (I) COVER TABLE REINFORCED 50" X 90" LIF (I) DRAPE HEAD WITH TAPE 44" X 26" LIF (I) COVER MAYO STAND REINFORCED LIF (I) BAG SUTURE FLORAL LIF (3) GOWN STANDARD LARGE SMS VEL/NE LABEL SAMPLE (I) COUNTER NEEDLE & BLADE 20C FOAM/MAG LIF ( I) STAPLE SKIN 35 WIDE LIF ( I) TUBE SUCTION CONNECT W' X 12' L/F ( I) PENCIL CAUTERY ROCKER SWITCH WITH HOLSTER LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (2) BLADE # I5 CARBON RIB ( I) NEEDLE SPINAL ANEST22G X 3\12 LIF ( I) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE 8.0 POWDER FREE LIF (2) *PR. GLOVE SURG. 6.5 POWDER LATEX (I) GUT PL FAST ABSORB 5-0 (2) SUTURE 2.0 VICRYL 25MM (3) TOWELS ABSORBENT 15" X 20" LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. 900-3083, 5 lots: 113109930 131210851 131210953 140111437 140312196 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices General Cosmetic Pack FCSC, Code 900-3113, contains: (1) COVER MAYO STAND REINFORCED LIF (10) LAP SPONGE PREWASH 18" X 18" XRD LIF (2) GOWN LARGE STANDARD SMS AAMIIII (1) TABLE COVER REINFORCED 50" X 90" LIF (2) TOWEL ABSORBENT 15" X 20" LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) SYRINGE BULB 60CC LIF (1) BLADE SURGICAL #15 CARBON STEEL (1) NEEDLE HYPODERMIC 18G X 1% LIF (6) TOWEL CLOTH HUCK BLUE LIF (4) DRAPE UTILITY WITH TAPE L/F (1) NEEDLE HYPODERMIC 25 X 1% L/F (1) SYRINGE 20CC WITHOUT NEEDLE LUER LOCK LIF (2) SYRINGE 10CC WITHOUT NNEDEL LUER LOCK LIF (2) NEEDLE SPINAL ANESHT 20G X 3%" LIF (1) SKIN MARKER WITH RULER LIF (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG L/F (1) LITE GLOVE (1) DRAPE BREAST/CHEST SMS LIF (1) TUBE SUCTION CONNECT%" X 12' LIF (10) GAUZE SPONGE 4" X 4" 16PLY L/F (2) GLOVE MEDIUM FREETOOUCH VYNIL POWDER FREE (1) TRAY 3/COMPARTMENT (1) WRAPPER 24" X 24" L/F (2) PK. SURG. GLOVE# 7% ENCORE POWDER FREE LATEX Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. 900-3113, 2 lots: 131110435 131210803 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Tummy Tuck Pack- FJG, code 900-3114, contains: (2) GOWN LARGE SMS IMPERVIOUS REINFORCED AAMI Ill (2) TOWEL ABSORBENT 15" X 20" (1) PENCIL CAUTERY PUSH BOTIOM ST. HOLSTER (1) NEEDLE HYPODERMIC 22G X 1 Y2 (2) SYRINGE 20CC WITHOUT NEEDLE LUER LOCK (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG (2) BOWL UTILITY QUART 32oz. (1) COVER MAYO STAND REINFORCED (2) MARKER SKIN WITH RULER (1) RULER (1) COVER TABLE REINFORCED 50" X 90" (2) CUP DENTURE 8oz TEAL WITH LID (6) TOWEL CLOTH HUCK BLUE (1) TUBE SUCTION CONNECT X" X 12' (1) YANKAUER SUCTION TUBE WITHOUT VENT (1) SHEET% DRAPE REINFORCED 60" X 77" (4) DRAPE UTILITY WITH TAPE (1 0) LAP SPONGE PREWASH 18" X 18" XRD (1) BLADE SURG. #15 CARBON STEEL (1) BLADE SURG. #1 0 CARBON STEEL (1) SYRINGE BULB 60cc (2) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE #6.5 P/F (2) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE #7 P/F (1) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE #7.5 P/F (1) SKIN STAPLE 35 WIDE (1) DRAPE TOP WITH ADHESIVE 108" X 50" STD SMS (2) DRAPE SIDE 42" X 76" WITH TAPE (1) DRAPE BOTIOM ABS REINFORCED 71" X 62" STD SMS WITH TAPE (1 0) GAUZE SPONGE 4" X 4" 16 PLY (1) PK. STRIP STERI CLOSURE W X 4" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. 900-3114, 2 lots: 131210804 140111438 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Liposuction Pack FJG, code 900-3115, contains: (2) GOWN LARGE SMS IMPERVIOUS REINFORCED AAMIIII LIF (2) TOWEL ABSORBENT 15" X 20" LIF (1) NEEDLE HYPODERMIC 25 X 1 LIF (1) BOWL UTILITY QUART 32oz LIF (1) COVER MAYO STAND REINFORCED L/F (20) GAUZE SPONGE 4" X 4" 16PLY LIF (1) COVER TABLE REINFORCED 44" X 78" LIF (2) CUP DENTURE 8oz TEAL WITH LID LIF (6) TOWEL CLOTH HUCK BLUE LIF (1) SAFETY SCALPEL #15 DISPOSABLE LIF (1) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK LIF (4) DRAPE UTILITY WITH TAPE L/F (1) SHEET% DRAPE REINFORCED 60" X 77" LIF (1) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE #7 P/F L/F (2) PR. GLOVE SURG CUSTOMGUARD CHLOROPRENE #6.5 P/F L/F (1) DRAPE TOP WITH ADHESIVE 108" X 50" STD SMS L/F (1) DRAPE BOTTOM ABS REINF. 71" X 62" STD SMS WITH TAPE L/F (2) DRAPE SIDE 42" X 76" WITH TAPE LIF (1) PVP IODOPHOR BOTTLE 4oz PAINT (1) SUCTION TUBING 8' X 3/8" ID NON CONDUCTIVE LIF (1) STRIP STERI CLOSURE Y2" X 4" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. 900-3115, 2 lots: 131211011 140111439 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Face Pack FJG, code 900-3116, contains: (2) GOWN LARGE STANDARD SMS AAMIIII (2) TOWEL ABSORBENT 15" X 20" (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG (1) COVER MAYO STAND REINFORCED (1) SHEET ENT SPLIT 11 0" X 77" SMS (1) COVER TABLE REINFORCED 44" X 78" (20) GAUZE SPONGE 4" X 4" 12PL Y (6) TOWEL CLOTH HUCK BLUE (1) PK. STRIP STERI CLOSURE W X 4" (2) CUP DENTURE 8oz TEAL WITH LID (1) SKIN MARKER WITH RULER (1) RULER (1) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK (1) SHEET o/. DRAPE 60" X 77" REINFORCED (1) BLADE SURG. #15 CARBON STEEL (1) BLADE SURG. #10 CARBON STEEL (4) DRAPE UTILITY WITH TAPE (1) SYRINGE BULB 60CC (2) Prs. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 6.5 P/F (2) Prs. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 7 P/F (1) Pr. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 7.5 P/F (1) YANKAUER SUCTION TUBE WITHOUT VENT (1) TUBE SUCTION CONNECT%'' X 12' (1) CAUTERY PENCIL PUSH BOTIOM HOLSTER Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. 900-3116, 1 lot: 131210805 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Breast Pack- FJG, code 900-3118, contains: (2) GOWN LARGE STANDARD SMS AAMIIII (2) TOWEL ABSORBENT 15" X 20" (1) PENCIL CAUTERY PUSH BOTTOM (1) SYRINGE BULB 60CC (1) TUBE SUCTION CONNECT~" X 12' (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG (1) BOWL UTIL TIY QUART 32oz (1) COVER MAYO STAND REINFORCED (2) SKIN MARKER WITH RULER (2) RULER (1) COVER TABLE REINFORCED 50" X 90" (2) CUP DENTURE 8oz TEAL WITH LID (6) TOWEL CLOTH HUCK BLUE (2) SYRINGE 20CC WITHOUT NEEDLE LUER LOCK (1) YANKAUER SUCTION TUBE WITHOUT VENT (1) DRAPE BREAST/CHEST SMS (10) SPONGE LAP PREWASH 18" X 18" XRD (1) SHEET% DRAPE REINFORCED 60" X 77" (4) DRAPE UTILITY WITH TAPE (1) BLADE SURG. #15 CARBON STEEL (2) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 6.5 POWDER FREE (2) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 7 POWDER FREE (1) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 7.5 POWDER FREE (10) GAUZE SPONGE 4" X 4" 16PLY (1) PK. STRIP STERI CLOSURE W' X 4" (1) NEEDLE SPINAL ANESTH 22G X 3Y2 (1) NEEDLE HYPODERMIC 22G X 1Y2 (1) IV PRIMARY ADD ADMINISTRAT SET (1) STOPCOCK 3WAY WSWIVEL MALE (1) SYRINGE 60ML WITHOUT NEEDLE LUER LOCK Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. 900-3118; 2 lots: 131210806 140111440 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Laparoscopy pack, , Code 900-3178, contains: (1) BULB SYRINGE 60cc LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) MAYO STAND COVER REINFORCED LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (3) GOWN SURG REINFORCED XL EXTRA LONG LEVEL IV (4) TOWEL ABSORBENT 15" X 20" LIF (1) DRAPE VIDEO CAMERA 13cm X 244cm LIF (3) LITE GLOVE LIF (1) DRAPE LAP ABDOMINAL W/POUCH 102" X 122" X 78" (1) BLADE SURGICAL# 11 (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (4) DRAPE UTILITY WITH TAPE LIF (1) SUTURE BAG FLORAL L/F (1) NEEDLE & BLADE COUNTER 10c MAG/CLEAR LIF (1) CABLE LAP 10FR 4MM MALE MONOP. LIF (1) SPECIMEN CONTAINER 4oz W/LID & LABEL (2) SHEET% 60" X 77" DRAPE REINFORCED LIF (1) TUBING INSUFFLATION SET W/0 RING ADAPTOR LIF (1) WRAPPER 24" X 24" LIF (1) ULTRA VERES NEEDLE 120MM LIF (1) TROCAR ENDO.XCELL DILATING TIP 11 MM (1) TROCAR ENDO.XCELL DILATING TIP 5MM LIF (1) CANNULA 5MM XCEL SLEEVES LIF (2) DENTURE CUP 8oz W/LID (2) DRESSING NON ADH TELFA 4" X 3" (1) CHLORAPREP 26ML APPLICATOR TEAL LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. 900-3178, 4 lots: 131210899 140211837 140312152 140513143 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Gown Impervious , Code 900-3190, contains: GOWN IMPERVIOUS EXTRA LONG X-LARGE WITH TOWEL & WRAP Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. 900-3190, 5 lots: 140111070 140211868 140312153 140412677 140513356 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Breast pack TPSC, code 900-3431, contains: (1) GOWN LARGE STANDARD SMS AAMIIII (1) GOWN SOFT SMS STD. X-LARGE AAMIIII (4) TOWELS ABSORBENT 15" X 20" LIF (1) PENCIL CAUTERY PUSH BOTTOM LIF (1) SYRINGE 60ML LUER LOCK WITHOUT NEEDLE L/F (1) TUBE SUCTION CONNECT X" X 12' LIF (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG L/F (1) COVER MAYO STAND REINFORCED LIF (2) SKIN MARKER INK WITH 8 LABEL/TIME OUT RULER LIF (2) BOWL UTILITY QUART 32oz. (1) COVER TABLE REINFORCED 50" X 90" LIF (1) RULER LIF (4) DRAPE UTILITY LIF (2) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) DRAPE BREAST/CHEST SMS LIF (1) GAUZE KERLIX 4.5"X 4 1/8 YD 6PL Y L/F (2) LITE GLOVES (5) SPONGE LAP PREWASH 18" X 18" XRD LIF (1) SHEET DRAPE 42" X 57" SMS LIF (1) SHEET DRAPE 70" x 100" LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. 900-3431, 1 lot: 140513333 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Open Heart Tray, Pack A, code 900-1196C, contains: (1) TABLE COVER REINFORCED L/Free (1) CARDIOVASCU.LAR INCISE DRAPE L/Free (2) 3/4 ABS. REINFORCED SHEET (1) PLASTIC SHEET (5) DRAPE SHEET SMS (18) CLOTH HUCK TOWELS Blue (4) CLOTH HUCK TOWELS White (1 0) ABSORBENT TOWELS L/Free (4) GOWN IMP. BREATHABLE LGE. (3) MAYO STAND COVER L/Free (2) IMPERV. STOCKINETTE (1) WRAPPER 54" X 54" (1) TRAY PLATFORM LGE (1) TABLE COVER HD L/Free (1) WRAPPER 24" X 24" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. 900-1196C, 25 lots: 109081948 111020513 111040952 111041136 111051468 111112924 111113162 112010244 112020547 112020554 112051555 112062220 112082996 112083217 112093966 112114785 113015636 113036439 113078353 113109656 131210739 140111446 140312370 140513169 140613799 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Cirugia Cardiovascular Case Cart, c ode 900-1415A, contains: (1) CIRUGIA CARDIOVASCULAR .(INDUCCION) (1) CIRUGIA CARDIOVASCULAR (CIRUGIA ) (1) CIRUGIA CARDIOVASCULAR (PREP ENFERMERA CIRCULANTE) (1) CIRUGIA CARDIOVASCULAR (PERFUSION SUPPLIES) (1) CIRUGIA CARDIOVASCULAR (POST- CIRUGIA) (1) OPEN HEART TRAY Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. 900-1415A, 7 lots: 109102236 140211906 140312233 140412870 140412872 140513354 140613716 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices LAPAROSCOPY COLORECTAL SURGICAL PACK code 900-2259A, contains: (1) SOLUTION SURGICAL DURAPREP 26ml LIF (4) DRAPE UTILITY WITH TAPE LIF (3) TOWELS ABSORBENT 15" X 20" LIF (2) LEGGINS W/7'' CUFF 30" X 42" LIF (1) BLADE SURGICAL# 15 STAINLESS STEEL (1) BLADE SURGICAL# 11 STAINLESS STEEL (1) GOWN IMPERV. EXTRA REINF. XLG AAMI Il l LIF (1) IRRIGATION SUCTION TROMPET DUAL SPIKE LIF (1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF (2) UTILITY BOWL 16oz. LIF (2) PK. STERI STRIP CLOSURE%'' X 4" L/F (1) ACTIFOG WITH FOAM PAD SOLUTION LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) MAYO STAND COVER REINFORCED LIF (1) NEEDLE ULTRA VERES 120MM LIF (1) STAPLE ARTICULATING ECHEL 60MM LIF (1) RELOAD WHITE 60MM ECHELON L/F (2) CANNULA 5MM XCEL SLEEVES LIF (1) TROCAR 5MM BLADELE W/STAB SLEEVE UF (1) TROCAR 12MM BLADELE W/STAB SLEEVE LIF (1 0) LAP SPONGES PREWASH 18" X 18" XRD LIF (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR LIF (2) LITE GLOVE (1) PENCIL CAUTERY ROCKER SWITCH WITH HOLSTER LIF (1) ELECTRODE DUAL DEPRES (1) LAPAROSCOPIC/LITHOTOMY DRAPE WITH CLEAR INSTRUMENT POUCHES (1) COUNTER NDLE/BLADE 20C FOAM/MAG LIF (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER LIF (1) BAG SUTURE FLORAL (1) GOWN IMPERV EXTRA REINFORCED LARGE TOWEL& WRAP LIF (1) POLISHER CAUTERY TIP LIF (1) BAG GLASSINE (1) RELOAD BLUE 60MM LIF (1) TIME OUT BEACON NON WOVEN LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. 900-2259A, 3 lots: 140312025 140412651 140612902 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Devices Lithotomy Pack III (3), code 900-2487, contains: (3) TOWEL ABSORBENT 15" X 20" (1) GOWN LARGE STANDARD SMS VELCRO NECK (2) LEGGINS WITH 7" CUFF 30" X 42" (1) DRAPE UNDERBUTTOCK WITH POUCH 44" X 35" (1) DRAPE ABDOMINAL WITH TAPE 40" X 54" (1) DRAPE UTILITY WITH TAPE (1) COVER TABLE REINFORCED 50" X 90" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. code 900-2487, 1 lot: 113078525 Class I Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. Customed, Inc
Food Golden Natural Mix Party Net Wt 23.00 oz. in a plastic round tub Product of Crown Food North Bergen, NJ 07047 UPC 098346021049 Sell By: 11/15/2014 Class I 'Golden Natural' Mix Party contains undeclared sulfites. Crown Food Distribution Inc
Devices Affinity® Four Birthing Bed, Product Usage: Product is intended to be used as birthing beds for women of child bearing age in an LDR (Labor, Delivery, Recovery) or LDRP (Labor, Delivery, Recovery, Postpartum) setting within the acute care Labor and Delivery market. Model #'s: P3700B, P3700C, P3700D and P3700E Class II The attachment latch mechanism can become bent depending on user handling. Latch mechanism bending could lead to improper engagement of the foot section and this could result in injury to the user due to a fall. Hill-Rom, Inc.
Devices Natural-Knee® System Pateella Bushings Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter. Part Number 6290-00-690. Lots Manufactured by Zimmer: 1327524, 1339783, 1344879, 1346702, 1361955, 1368604, 1382204, 1386058, 1388164, 1429297, 1437553, 1441291, 1441897, 1451867, 1465171, 1470848, 1470849, 1472371, 1516851, 1530342, 1538118, 1547978, 1555574, 1560246, 1565076, 1583036, 1593277, 1594775, 1595926, 1598696, 1601040, 1606098, 1606511, 170454, 171324, 173342-09, 173342-10, 173342-2, 173342-3, 173342-9, 601863, 60319687, 60339959,  ...
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Class II Zimmer received a trend of complaints indicating corrosion of product. Zimmer, Inc.
Devices Natural-Knee® System Patella Bushings Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter. Part Number: 6290-00-702. Lots Manufactured by Zimmer: 1324203, 1339203, 1346701, 1363348, 1373979, 1382208, 1385813, 1391253, 1421647, 1437118, 1440906, 1440943, 1451869, 1464915, 1469681, 1470531, 1472373, 1474483, 1538141, 1549267, 1552408, 1554291, 1554292, 1567743, 1598694, 1601263, 1601606, 1606096, 1606957, 170454, 172361, 173342-10, 173342-3, 173342-8, 173342-9, 596146, 597424, 60278535, 60305599, 60319668, 60426581, 60557544, 60712149,  ...
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Class II Zimmer received a trend of complaints indicating corrosion of product. Zimmer, Inc.
Devices Natural-Knee® System Patella Bushings Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter. Part Number: 6290-00-703. Lots Manufactured by Zimmer: 1324204, 1346689, 1361954, 1371127, 1374460, 1382191, 1386076, 1388163, 1421648, 1440890, 1441119, 1476227, 1476229, 1493832, 1493841, 1516853, 1530324, 1549264, 1549388, 1554288, 1554290, 1560754, 1563440, 1598691, 1598692, 1598693, 1598695, 1601605, 1606099, 1606510, 170675, 172016, 173342-09, 173342-10 , 173342-3 , 173342-5, 173342-9 , 601804, 60278820, 60310873,  ...
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Class II Zimmer received a trend of complaints indicating corrosion of product. Zimmer, Inc.
Devices Natural-Knee® System Patella Bushings Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter Part Number 6290-00-704. Lots Manufactured by Zimmer: 1137602, 1324205, 1331331, 1346218, 1351208, 1368598, 1373552, 1376006, 1382199, 1386059, 1422626, 1426895, 1438006, 1441899, 1475757, 1475758, 1478938, 1493445, 1517176, 1525953, 1525954, 1549263, 1551990, 1554289, 1556787, 1560245, 1596097, 1601264, 1601980, 1606097, 1606956, 170675, 172228, 173342-3, 173342-8, 173342-9, 593336, 597424, 60259011, 60293370, 60305590, 60380932, 60398259,  ...
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Class II Zimmer received a trend of complaints indicating corrosion of product. Zimmer, Inc.
Devices Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per package) and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. Product Codes: Y001, Y002, Y003, Y004, Y005, Y006, Y007, Y008, Y009, Y010, Y011, Y012, Y014, Y015, Y016, Y101, Y102, Y103, Y105, and Y951. To be updated as firm submits information. Class II The Gradient Coil was found to have a failure mode that allowed it to overheat and become a burn hazard. Hitachi Medical Systems America Inc
Cosmetics OGX 50% More Free Thick and full Biotin and Collagen Conditioner 19.5 fl.oz/577ml and 13 fl oz/385 ml e Dist by Vogue International, Clearwater, FL (Purple Bottle) 19.5 fl oz:UPC: 022796918499; Batch #'s: F1422800 and F1422801. 13 fl oz: UPC: 022796916716 ; Batch #'s: F1420702, F1420703, F1420704. F1420705 and F1420707. Class II Due to the presence of Burkholderia cepacia. Vogue International
Biologics Blood and Blood Products for Reprocessing W140514441312; Class III Blood product, in which the donor screening/donor record was incomplete or incorrect, was distributed. Childrens Hospital Colorado Transfusion Medical Services
Biologics Platelets Pheresis Leukocytes Reduced W036514080032; W036514080032; W036514037192; W036514037192; Class II Blood products, collected using automated equipment that lacked validation, were distributed. LifeShare Blood Centers
Biologics Platelets Pheresis W200314805338; Class III Platelets with incorrect or missing information, were distributed. The American National Red Cross - Southern Region
Biologics Red Blood Cells W116514325191P; Class III Blood product, prepared without the appropriate amount of additive (ADSOL), was distributed. Central Shared Services, LLC.
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W2876140014486; Class II Blood product, labeled with an incorrect expiration date, was distributed. Blood Systems, Inc. DBA United Blood Services
Biologics Red Blood Cells Leukocytes Reduced W036808157431; Class II Blood product, in which routine testing/testing performed, interpreted, or documented incorrectly, was distributed. OneBlood, Inc.
Food Organic Carob Powder; Certified Organic, Product of Italy. Store in Cool, Dark place. Packaged in 16 oz., 5 lb., 20 lb and 55 lb. containers. 16 oz.. - 6 per case; 5 lb. - 6 per case; 20 lb. - 2 per case; 55 lb. - 1 per case. Earth Circle Organics; Grass Valley, CA Product SKU Lots #;s UPC code CRBP 16 oz.; 3642, 3404, 3221, 3267 894932002283; CRBP 5 lb; 3405, 3262 894932002733; CRBP 20 lb. 3487, 3387, 3292 813313011485; CRBP 55 lb. 201901, 196201, 194801, 188901, 0786 894932002740. All lots expire 6/15/2015. Class I Firm was notified by supplier of recall or Organic Carob Powder that they repacked has been recalled due to Salmonella contamination. River Canyon Retreat
Devices PERSONA The Personalized Knee System Constrained Tibial Articular Surface Provisional BOTTOM with the following: L CD +0MM; L CD +6MM; L EF +0MM;L EF +6MM; L GH +0MM; L GH +6MM; L J +0MM; L J +6MM; R CD +0MM; R CD +6MM; R EF +0MM; R EF +6MM; R GH +0MM; R GH +6MM; R J +0MM; R J +6MM; and Part Numbers: 42517600303, 42517600313, 42517600505, 42517600515, 42517600707, 42517600717, 42517600909, 42517600919, 42527600303, 42527600313, 42527600505, 42527600515, 42527600707, 42527600717, 42527600909, and 42527600919. Lot numbers: 62345370, 62402721, 62423922, 62424796, 62494665, 62563912, 62590524, 62696878, 62717331, 62347233, 62399612, 62428432, 62505575, 62563917, 62592279, 62692687, 62352330, 62416376, 62432157, 62490790, 62563913, 62590525, 62696881, 62357329, 62374803, 62412999, 62432797, 62490792, 62563911,  ...
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Class II Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this instrument are aware of the enhanced surgical techniques. Zimmer, Inc.
Devices PERSONA The Personalized Knee System Constrained Posterior Stabilized Tibial Articular Surface Provisional TOP with the following: L 3-5 CD; L 6-9 CD; L 3-5 EF; L 6-9 EF; L 10-11 EF; L 6-9 GH; L 10-12 GH; L 10-12 J; R 3-5 CD; R 6-9 CD; R 3-5 EF; R 6-9 EF; R 10-11 EF; R 6-9 GH; R 10-12 GH; and R 10-12 J. Part Numbers: 42517600410, 42517600510, 42517600610, 42517600710, 42517600810, 42517600910, 42517601010, 42517601110, 42527600410, 42527600510, 42527600610, 42527600710, 42527600810, 42527600910, 42527601010, and 42527601110. Lot numbers: 62342526, 62423918, 62423919, 62423920, 62427414, 62482212, 62563745, 62612225, 62656072, 62740698, 62342527, 62405895, 62430401, 62504179, 62511925, 62563784, 62638665, 62695870, 62343066, 62406967, 62432146, 62515486, 62564324, 62691390, 62717335, 62351291, 62374838, 62415307, 62430397,  ...
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Class II Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this instrument are aware of the enhanced surgical techniques. Zimmer, Inc.
Devices PERSONA The Personalized Knee System CR Tibial Articular Surface Provisional with the following: Left Size 3-9 CD Top; Left Size 3-11 EF Top; Left Size 7-12 GH Top; Left Size 9-12 J Top; Left Size 3-9 CD Top; Left Size 3-11 EF Top; Right Size 7-12 GH Top; and Right Size 9-12 J Top. Part Numbers: 42517000410, 42517000510, 42517000610, 42517000710, 42527000410, 42527000510, 42527000610, and 42527000710. Lot numbers: 62024975, 62043546, 62144792, 62152725, 62165538, 62187318, 62337961, 62372407, 62386776, 62397159, 62405917, 62456263, 62499170, 62551386, 62565051, 62568272, 62572572, 62663168, 62691384, 62707494, 62717346, 62020920, 62144793, 62156313, 62165539, 62184228, 62353932, 62356176, 62385100, 62420242, 62468277, 62538412, 62564340, 62611088, 62612263, 62690056, 62702295,  ...
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Class II Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this instrument are aware of the enhanced surgical techniques. Zimmer, Inc.
Devices PERSONA The Personalized Knee System Tibial Articular Surface Provisional Left with the following: Size CD +0 mm Thickness Bottom(TB); Size CD +6 mm Thickness Bottom; Size EF +0 mm Thickness Bottom; Size EF +6 mm TB; Size GH +0 mm TB; Size GH +6 mm TB; Size J +0 mm TB; Size J +6 mm TB; Right Size 1-2 CD +0 mm TB; Right Size CD +6 mm TB; Right Size EF +0 mm TB; Right Size EF +6 mm TB; Right Size GH +0 mm TB; Right Size GH +6 mm TB; Right Size J +0 mm TB; and Right Size J +6 mm TB. Part Numbers: 42517000303, 42517000313, 42517000505, 42517000515, 42517000707, 42517000717, 42517000909, 42517000919, 42527000303, 42527000313, 42527000505, 42527000515, 42527000707, 42527000717, 42527000909, and 42527000919. Lot numbers:62022340, 62024973, 62062232, 62104367, 62187314, 62187315, 62190367, 62190370, 62265725, 62301862, 62314675, 62355857, 62385126, 62385132, 62403987, 62414017, 62420244, 62456269, 62506026, 62506044, 62531664, 62558106, 62564325, 62596552, 62600208, 62614790, 62683419, 62691385, 62698730, 62716777,  ...
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Class II Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this instrument are aware of the enhanced surgical techniques. Zimmer, Inc.
Devices PERSONA The Personalized Knee System PS Tibial Articular Surface Provisional Left with Size 3-5 CD Top; Size 6-9 CD Top; Size 3-5 EF Top; Size 6-9 EF Top; Size 10-11 EF Top; Size 6-9 GH Top; Size 10-12 GH Top; Size 10-12 J Top; and RIGHT Size 3-5 CD Top; Right Size 6-9 CD Top; Right Size 3-5 EF Top; Right Size 6-9 EF Top; Right Size 10-11 EF Top; Right Size 6-9 GH Top; Right Size 10-12 GH Top; and Right Size 10-12 J Top. Part Numbers: 42517400410, 42517400510, 42517400610, 42517400710, 42517400810, 42517400910, 42517401010, 42517401110, 42527400410, 42527400510, 42527400610, 42527400710, 42527400810, 42527400910, 42527401010, and 42527401110. Lot numbers:62043556, 62110045, 62121489, 62125589, 62147235, 62165546, 62168383, 62177247, 62311021, 62314722, 62386421, 62442838, 62525491, 62558585, 62605208, 62627292, 62683432, 62696865, 62717343, 62022344, 62041351, 62073566, 62104372, 62117744, 62121488, 62149175, 62187324, 62187325, 62247351, 62311022,  ...
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Class II Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this instrument are aware of the enhanced surgical techniques. Zimmer, Inc.
Devices PERSONA" The Personalized Knee System UC Tibial Articular Surface Provisional Left Size 3-7 CD Top; Left Size 4-11 EF Top; Left Size 7-12 GH Top; Left Size 9-12 J Top; Right Size 3-7 CD Top; Right Size 4-11 EF Top; Right Size 7-12 GH Top; and Right Size 9-12 J Top. Part Numbers: 42517200410, 42517200510, 42517200610, 42517200710, 42527200410, 42527200510, 42527200610, and 42527200710. Lot numbers:62034570, 62117742, 62156315, 62187322, 62247350, 62314721, 62372409, 62381836, 62397160, 62429190, 62474906, 62551390, 62565048, 62595853, 62614781, 62700416, 62702297, 62724349, 62043548, 62055681, 62104368, 62117743, 62144794, 62165545, 62177246, 62256282, 62351288, 62356244, 62391228, 62427419, 62456268, 62506003, 62551338, 62564355, 62597762, 62614786, 62702292, 62705808,  ...
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Class II Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this instrument are aware of the enhanced surgical techniques. Zimmer, Inc.
Food gomacro MACROBAR brand almond butter + carob. Net Wt. 2 oz (57 g) 10MAR15, Lot 1634, and 18MAR15, Lot 1645 Class I GoMacro is recalling MARCO BARS brand almond butter + carob (lots 1634 and 1645), and sunflower butter + chocolate (lot 1646) because they have the potential to be contaminated with Salmonella. GoMacro, Inc.
Food gomacro MACROBAR brand sunflower butter + chocolate Net Wt. 2.3 oz (65 g) 18MAR15 Lot 1646 Class II GoMacro is recalling MARCO BARS brand almond butter + carob (lots 1634 and 1645), and sunflower butter + chocolate (lot 1646) because they have the potential to be contaminated with Salmonella. GoMacro, Inc.
Food Organic Carob Powder, 1 lb., 20 lb., and 55 lb. bags Expiry date: 6/5/2015, UPC Code 803813-04429-8 Lot Numbers- 140616;140516;140416;140321;140609;140509;140623 Class I Sunfood Corporation is recalling Organic Carob Powder because it may be contaminated with Salmonella Sunfood Superfoods
Devices Roche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to store, retrieve, and process laboratory data. Part Numbers: 04420306001 Serial #'s: 2706, 2724, 2743, 2744, 2745, 2749, 2750, 2751, 2752, 2754, 2755, 2764, 2770, 2771, 2772, 2773, 2774, 2775, 2776, 2780, 2781, 2782, 2783, 2784, 2785, 2789, 2790, 2791, 2792, 2793, 2794, 2795, 2796, 2797, 2798, 2799, 2808, 2814, 2815, 2816, 2818, 2819, 2823, 2824, 2825, 2826,  ...
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Class II It has been internally found that if cobas IT 1000 receives an ADT ADMIT, TRANSFER or MERGE event message that contains a genuine Patient ID (e.g. 999999), which is the same as what has been configured in cobas IT 1000 as the Generic Patient ID (999999 by default) it can assign previously stored generic patient test results to the newly created patient ID. This issue has not been reported by any customers; however the outcome of the issue is that test results would be assigned to the wrong Patient ID. Roche Diagnostics Operations, Inc.
Biologics Source Plasma 3770199794; 3770199121; Class II Blood products, collected from a donor who did not have a complete physical examination, were distributed. Talecris Plasma Resources, Inc.
Biologics Platelets Leukocytes Reduced Irradiated W038214040413; Class III Blood products, in which CMV testing was performed with an expired reagent, were distributed Kentucky Blood Center Inc
Biologics Platelets Pheresis Leukocytes Reduced W038214041538; W038214041538; W038214041538; Class III Blood products, in which CMV testing was performed with an expired reagent, were distributed. Kentucky Blood Center Inc
Biologics Red Blood Cells Leukocytes Reduced W038214040416; W038214040418; W038214033686; W038214033688; W038214040389; W038214040391; Class III Blood products, in which CMV testing was performed with an expired reagent, were distributed. Kentucky Blood Center Inc
Biologics Red Blood Cells Leukocytes Reduced W120614600847; Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, was distributed. Michigan Blood
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W118813524645(Part A); W118813524645(Part B); Class II Blood products, which did not meet acceptable product specifications, were distributed. The Blood Alliance, Inc.
Devices GALT VALVED TEARAWAY INTRODUCER SET GALT VTI RX ONLY UNITS 7 STERILE EO Product Usage: Used in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature. Catalog Numbers: NT-104-06, INT-104-07, INT-104-08, INT-104-09, INT-104-10, INT-104-11, INT-104-12, INT-104-17, INT-104-18, INT-104-19, INT-104-20, INT-104-21, INT-104-22, INT-104-23, INT-108-06, INT-108-07, INT-108-09, INT-108-10, INT-108-11, INT-108-12, INT-108-17, INT-108-18, INT-108-19, INT-108-20, INT-108-21, INT-108-22, INT-108-22, VTI-002-06, VTI-002-07, VTI-002-08, VTI-002-09, VTI-002-09, VTI-002-10, VTI-002-11, VTI-002-12, VTI-002-17, VTI-002-18, VTI-002-19, VTI-002-20, VTI-002-21, VTI-002-22, VTI-002-23, VTI-003-06, VTI-003-07, VTI-003-08, VTI-003-09, VTI-003-10, VTI-003-11,  ...
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Class II The adhesive used in the product could dislodge when objects are inserted through the valve which could pose an embolic risk to the patient. Galt Medical Corporation
Devices GALT VALVED TEARAWAY KIT GALT VTI w/ Sideport Stainless Steel Dbl Flex. J-St RX ONLY UNITS 1 STERILE EO Product Usage: Used in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature. Catalot Numbers: KIT-043-06, KIT-043-07, KIT-043-08, KIT-043-09, KIT-043-10, KIT-043-11, KIT-053-06, KIT-053-07, KIT-053-08, KIT-053-09, KIT-053-10, KIT-053-11, KIT-053-12, KIT-053-17, KIT-053-18, KIT-053-19, KIT-053-20, KIT-053-21, and KIT-053-22 Class II The adhesive used in the product could dislodge when objects are inserted through the valve which could pose an embolic risk to the patient. Galt Medical Corporation
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated W20031401378800; W20031401381900; W20031403832200; W20031404091100; W20411401107700; W20031403581500; W20031402579900; Class III Blood products, labeled with an incorrect expiration date, were distributed. The American National Red Cross - Southern Region
Biologics Red Blood Cells Leukocytes Reduced Irradiated W036214140275; W0362141402550 Class III Blood products, which were out of controlled storage for 30 minutes during irradiation, were distributed. Belle Bonfils Memorial Blood Center
Food Lacteos Santa Martha Quesito Casero Fresh Curd Net Weight 12oz Distributed by Oasis Brands Inc., Miami FL 33192 UPC 635349 000420 / Exp. Date 092714 Class I A State sample came positive for Listeria monocytogenes Oasis Brands, Inc
Food Sunburst SUPERFOODS ORGANIC RAW CAROB POWDER in ONE POUND and 5 POUNDS bags --- Firm on label: SunburstSuperfoods.com Clifton, NJ (old label) and SunburstSuperfoods.com Tuckahoe, NY (new label) Uncoded Class I The repacked product has the potential to be contaminated with Salmonella (from raw material). Super Organic Foods, Inc
Devices Siemens EasyLink" Informatics System V4.0/V5 Siemens, Material Number (SMN) 10444799, 10444800, 10487219 Product Usage: The EasyLink Data Management System is a clinical data management system that assists medical laboratory professionals with preanalytic and post-analytic functions in conjunction with multiple instruments, the laboratory information system (LIS) and Siemens StreamLAB® Automation Solutions. It provides: autoverification, integrated QC capabilities, and remote services to help keep systems running optimally and audit trail capabilities. EasyLink" Informatics System V4.0/V5 Siemens Material Number (SMN) 10444799, 10444800, 10487219 Class II Under certain conditions, the Siemens EasyLink Data Management System may not perform as intended, causing the release of results to the Laboratory Information System (LIS) that should have been held for manual review due to auto-verification rules or the delay/omission of result transmission to the LIS. Siemens Healthcare Diagnostics, Inc.
Drugs Paroxetine HCL Controlled-Release Tablets 12.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3673-3 Lot # 2A001, Exp. 01/15 Lot # 2A002, Exp. 01/15 Lot # 2C003, Exp. 03/15 Lot # 2F005, Exp. 06/15 Lot # 2G006, Exp. 07/15 Class II Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents. Apotex Inc.
Drugs PAXIL (Paroxetine HCL) Oral Suspension 10 mg/5 mL - 250 mL bottle, Rx Only, Manufactured by GlaxoSmithKline, RTP, NC 27709. Distributed by Apotex Corp., Westin, FL 33326, NDC 60505-0402-5 Lot # 2A001, Exp. 01/15; Lot # 2C002, Exp. 03/15 Class II Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents. Apotex Inc.
Drugs Paroxetine HCL Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3674-3 Lot # 2A002, Exp. 01/15 Lot # 2A003, Exp. 01/15 Lot # 2C004, Exp. 03/15 Lot # 2C005, Exp. 03/15 Lot # 2E008, Exp. 05/15 Lot # 2F009, Exp. 06/15 Lot # 2F010, Exp. 06/15 Lot # 2H011, Exp. 08/15 Lot # 2H012, Exp. 08/15 Lot # 2H013, Exp. 0815 Class II Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents. Apotex Inc.
Drugs Paroxetine HCL Controlled-Release Tablets 37.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3675-3 Lot # 2C002, Exp. 03/15 Lot # 2H004, Exp. 08/15 Lot # 2H006, Exp. 08/15 Class II Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents. Apotex Inc.
Drugs PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3669-3 Lot # 2F004, Exp. 06/15 Class II Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents. Apotex Inc.
Drugs PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 37.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3670-3 Lot # 2E001; Exp. 05/15 Class II Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents. Apotex Inc.
Drugs PAXIL (Paroxetine HCL) Tablets 10 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3663-3 Lot # 2ZP7113, Exp. 08/15 Class II Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents. Apotex Inc.
Drugs PAXIL (Paroxetine HCL) Tablets 20 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3664-3 Lot # 2ZP5499, Exp. 02/15 Class II Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents. Apotex Inc.
Drugs PAXIL (Paroxetine HCL) Tablets 40 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3666-3 Lot # 2ZP3908, Exp. 05/15 Class II Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents. Apotex Inc.
Food Puratos Chocolante, Dark Organic 1M Chip, Item Number 0065064002SH11, Net Weight: 25 lbs. Lot: 310212736, Best Before: 08/20/15 Class I Puratos initiated a recall due to an allergic reaction to milk protein, reported by a consumer. Puratos Chocolate USA
Devices Medsolutions4U Multi-Function Electrodes to be used with PhysioControl Lifepak Defibrillators, models 9, 10C, 11, 12, 15, 20, 500 and are indicated for Defibrillation, Cardioversion, Pacing, and Monitoring Part Number: 2033 Lot #0413 Expiration Date: 2015-01-26 Class II Medsoultions4U Multi-Function Lifepak Electrodes, manufactured with an incorrect wire connector which could not interface with the defibrillators Bio-Detek, Inc.
Food Choripdong Chocolate Almond Richmond Ice Bar 4 bars/432 mL Seoul Trading USA Inc., Englewood NJ 07631 code # IC1006 and upc code: 761898632925 3/20/2015 Class I Seoul Trading USA Inc. is recalling Choripdong Chocolate Almond Richmond Ice Bar due to undeclared eggs. Seoul Shik Poom, Inc.
Food Avocados Simmons in white cardboard flats with black lettering "FLORIDA AVOCADO US COMB" 10 count #10 handwritten in black ink on carton Lot # 053*45615 Class I FDA sample found the product contaminated with traces of Salmonella. Homestead Pole Bean Cooperative, Inc.
Food Ortho Molecular Products LifeCORE, Rich Dark Chocolate, Dietary Supplement Net Wt. 732.2 Grams (25.8Oz), Product #927001, UPC 15033-00927 Lot numbers beginning with the following numbers: 73286, 73288, 73455, 73482, 73569, 73620, 73840, 73859, 73987, 74038, 74419, 74562, 74773, 74920, 75309, 75339, 75568, 75749, 75919. Expiration dates: Feb-13 thru Apr-15 Lot number and expiration date can be located at the neck of the bottle just above the label. Class I Ortho Molecular Products is recalling all lots of LifeCore Chocolate and LifeCore Complete Chocolate because the flavoring may contain undeclared milk. Ortho Molecular Products Inc
Food Ortho Molecular Products LifeCORE Complete, Rich Dark Chocolate, Dietary Supplement, Sold in the following size containers: 1. Net Wt. 32.6 Grams (1.2Oz), Product #929032, UPC 15033-01929; 2. Net Wt. 911.4 Grams (32.1oz), Product #929001, UPC 15033-00929. Lot numbers beginning with the following numbers: 73286, 73288, 73455, 73482, 73569, 73620, 73840, 73859, 73987, 74038, 74419, 74562, 74773, 74920, 75309, 75339, 75568, 75749, 75919. Expiration dates: Feb-13 thru Apr-15 Lot number and expiration date can be located at the neck of the bottle just above the label. Class I Ortho Molecular Products is recalling all lots of LifeCore Chocolate and LifeCore Complete Chocolate because the flavoring may contain undeclared milk. Ortho Molecular Products Inc
Devices Focal Sim Product Usage: The FOCAL Workstation will continue to be used for patient contouring and viewing of treatment plan outputs. With this new software it will also be able to perform CT simulations and forward their information to the RTP System for dose calculation. Software versions 4.70.00 & 4.80.00 Class II When DICOM's exporting an arc plan (VMAT, Dynamic Conformal of 3D Static Arcs) and using the Composite Field Sequencing (CFS) feature, the DICOM exported plan will not match the approved treatment plan. Elekta, Inc.
Devices Monaco The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and displays, on-screen and in hard-copy, two or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups. Versions 3.20.00 and higher Class II When DICOM's exporting an arc plan (VMAT, Dynamic Conformal of 3D Static Arcs) and using the Composite Field Sequencing (CFS) feature, the DICOM exported plan will not match the approved treatment plan. Elekta, Inc.
Food Brown carob powder packed in a plastic heat sealed 16oz. bag, labeled in part "Live Superfoods Carob Powder***NET WT 16 OZ***Live Superfoods Bend, Oregon". UPC code 797734313543 The product also sold in 10 lbs. bags. 20140097 sell by 3/1/2016; 20140098 sell by 3/1/2016 (this is for 10 lbs. bag); 20140164 sell by 6/1/2016. Class I Live Superfoods was notified of a recall of organic carob powder by their supplier, Earth Circle Organics, on July 23, 2014. Live Superfoods re-packed organic carob powder for further distribution and is also voluntarily recalling this product due to potential Salmonella contamination. Live Superfoods
Devices Split Cath III Trays, 16F x 28CM Product Usage: The Split Cath III is indicated for use in attaining long term vascular access for hemodialysis and apheresis in adult patients. TRAY #55216-3; Lot numbers: MBTX960, exp. 10/2016; MBVA850, exp. 10/2016; MBVD080, exp. 01/2017; MBVG680, exp. 01/2017; MBVL020, exp. 01/2017. Class II The Split Cath III Trays were incorrectly labeled as 16F x 32CM Split Cath III instead of 28CM. Medical Components, Inc dba MedComp
Devices iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. Indicated for fluid infusion and aspiration during surgery. Lot number 1404-03; Expiration: March 31, 2016 Class II One lot may not have been properly sealed, resulting in a non-sterile device. Ellex iScience, Inc.
Devices EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer REF 351-3380SZ 380 cc LOT 6830722. Product Usage: This product is indicated for single use for temporary insertion intraoperatively to evaluate the volume of the breast implant to be implanted. Mentor Sterile Saline Mammary Volume Sizer (Sizer) is a silicone elastomer device designed for temporary intraoperative placement in the surgically prepared mammary pocket. The Sizer is used to evaluate the appropriate mammary prosthesis volume for each patient prior to implant of a mammary prosthesis. The Sizer is inflated to its optimal volume with saline after it is placed within the pocket, and then deflated prior to its removal. Part Number (PN) 351-3380SZ Lot Number 6830722 Class II The device labeling is stamped with 330cc and the device is actually 380cc device. Mentor Texas, LP.
Devices STREAMLINE CT CERVICO-THORACIC SYSTEM; SET SCREW REF 26-SETSCREW NON-STERILE, SINGLE USE, RX ONLY Lot numbers: 104875, 104876, 104877, 104878, 104879, 104880, 104881 , 117030,117031 , 121947, 124260. Class II Some set screw thread profiles were found not to be within specifications. PIONEER SURGICAL TECHNOLOGY, INC.
Devices ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 10.0mm Product Usage: The OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system that offers both the fixation devices and instrument in one system. The insertion tool is used with a mallet to tap the tunnel sleeve implant into a counter-bored hole in the bone. Part #: Lot Code: 01-1008-0040 132762 01-1008-0041 F132764, F132763 01-1008-0042 F132763, F132764 01-1008-0043 F132765, F132766 01-1008-0044 F132766, F132765 01-1008-0045 F132768 01-1008-0046 F132769 01-1008-0047 F132770 Class II Weld fractures on the Sleeve Installation Tool for ACL reconstruction system. OrthoPediatrics Corp
Devices LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group Part Number - 0684-00-0480-01U Class III During label reconciliation a duplicate serial number label was detected to be printed for the LINEAR 7.5 FR 40 cc Intra-Aortic Balloon Catheter. Datascope Corporation
Devices Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409. Serial Numbers: 1004962 1004963 1004964 1004965 1004966 1004967 1004968 1004969 1004970 1004971 1004972 1004973 1004974 1004975 1004976 1004977 1004978 1004979 1004980 1004981 1004982 1004983 1004984 1004985 1004986 1004987 1004988 1004989 1004990 1004991 1004992 1004993 1004994 1004995 1004996 1004997 1004998 1004999 1005000 1005001 1005002 1005003 1005004 1005005 1005006 1005007 1005008 1005009  ...
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Class II St. Jude is recalling the Ellipse family of Implantable Cardioverter Defibrillator (ICD) devices because of an anomaly that may result in delayed delivery of high voltage therapy or prevent delivery of part or all of a programmed high voltage therapy shock. The anomaly occurs as a result of internal damage to the capacitors used in the high voltage charging circuitry of the subject devices, which may result in an extended charge time. The anomaly most commonly presents as a vibratory patient notification and upon interrogation, a programmer or Merlin.net alert indicating a "Capacitor Charge Time Limit reached" message. This may occur during a capacitor maintenance or charging for high voltage therapy. St Jude Medical Cardiac Rhythm Management Division
Devices ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment. Serial numbers: 6281-002500, 6281-002501, 6281-002659, 6281-002661, 6281-002662, 6281-002663, 6281-002664, and 6281-003056. Model 96281, with SpO2 Option C. Class II The AriaTele Model 96281 with SpO2 monitoring Option C is recalled because the AriaTele (transmitter) display and the Telemetry Central Station display may show a SpO2 value when the sensor is not connected to the patient or in certain sensor failed conditions. This is an expansion of RES 67243 Z-0871-2014 because additional serial numbers were identified as being part of this recall action as part of the firm's retrospective analysis of all recalls since 2011. Spacelabs Healthcare Inc
Devices V5Ms Transesophageal transducers; V5Ms trans-esophageal echocardiograph (TEE) ultrasound transducer is intended primarily for cardiology applications Model numbers 8264577 and 8263703; Serial numbers: US: 33707625 32807460 34507747 42208166 S34707777 32907477 33007494 33307538 33507577 33507584 33707612 34107671 34707781 40908018 41508085 41608100 41908126 41908129 S34607757 S34907818 33907638 33907642 34807802 33007497 34207690 34307704 34607760 40607983 41808117 41908127 35107862 35107863 40107882 40407947 S34307696 33707631 34207694 33007487 41508082 41608089 34707771 41708101 33207509 33207519 33207522 33707622 34907824 35107872 40107896 42008137 33207520 41708109 S34607755 33307537 33607596 33707619 34607768 41808119 33707630 42008136 40407946 34207680 34607762 40808002 41008037 41708108 S33207505 33507578 41108046 41308062 42008132 34307703 34707778 40307937 40407951 40808007 41908128 40207906 32907474 33307539 34607758 35107875 40908017 41308054 41508088 41508080 41508087 33507576 33607590 33707621 40407958 40607982 41008032 41808118 42208161 42208163 41408065 33207513 33407545 33507575 33707615 33707624 34207693 34707785 35107867 35107868 40307938 40707986 S33007483 S33707609 40307940 42208165 41108044 42108156 42108157 41508076 42008133 34307712 34007659 32807451 32807459 34207678 34307702 34707787 34907832 40607979 40607980 41808120 41908125 32807454 33707614 41008033 34407716 34707776 S33007481 S34307698 S34407722 33507569 34607764 34907840 40707991 40407944 33907651 33907633 34807811 34907838 34207695 41108041 S34307700 33407553 35007855 40407949 40307924 40307927 S33307527 32907479 33007498 33507582 33907635 34007662 34707782 34907831 40407955 41608096 40707988 ROW: 35007853 40807999 34307711 40607974 40207909 34607767 40307933 33407548 40107885 34507743 33907648 42108150 40207910 33607599 32907471 35107859 40707992 41608093 40507963 34807806 40107887 41008038 33907636 34807807 41008034 34807810 S34007656 S34607750 33707607 33507572 34807805 42108154 40207913 42108144 40807998 42108145 33907640 33207510 40707985 40107900 34707779 40707984 35007847 40107890 40507966 41108042 40207903 42008134 41508081 34407730 40307932 40908016 40207907 40808005 34807795 33607587 34007664 34807809 40207912 33907643 33907634 34707790 40507971 41708106 40407943 41408068 33507581 34407726 40307935 33507585 42008139 34607751 S34307697 34407725 S32907463 S33407560 33507574 40507962 33607592 33207515 40307925 S34507742 41408073 S40207904 S33307531 40707990 40707996 34707770 33507568 40607977 35007857 40707995 S35007846 S34707775 S34907821 40107884 S34307699 S34607748 34007665 41408072 S33707608 S33407549 34807797 42108155 S32907466 40307929 41008027 40207908 S33407561 33007486 S34907822 34407718 S33007485 S33307532 41308056 40307926 S33007488 41208048 S40207902 34007660 33607600 33507571 S33907653 41608099 S34507738 S33507570 34307705 34807808 40207922 34507745 34307714 33507566 40307923 41208051 33407543 42208164 41708107 40808009 40507970 40808010 33207514 40908019 40207921 41808116 S34607753 41608098 41408066 41908122 41908123 34507746 40107881 40507968 33407556 35207880 34407732 41008030. Class II Reports of deterioration of material covering the articulating section of the V5Ms transesophageal transducer. Siemens Medical Solutions USA, Inc.
Drugs Comfort Shield Barrier Cream Cloths with dimethicone a) 8 count NDC 53462-915-80, b) 24 count NDC 53462-915-60, OTC, SAGE PRODUCTS INC., 3909 Three Oaks Road, Cary, IL 60013 Lot: 44385; Exp.06/16; Lot: 44669; Exp.12/15 Class II Microbial Contamination of Non-Sterile Products: Comfort Shield Barrier Cream Cloth packages tested positive for bacterial contamination. Sage Products Inc
Drugs OXYCODONE and ACETAMINOPHEN, USP 10 mg/325 mg, CII, 100 TABLETS, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-4982-21 T062A14A, Exp 12/15 Class II Failed Tablet/Capsule Specifications: Broken tablets found in sealed bottles. Qualitest Pharmaceuticals
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