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U.S. Department of Health and Human Services

Enforcement Report - Week of July 9, 2014

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Devices ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN 10310370, and Ancillary Pack Catalog number 03302138 (124581), SMN 10378677. Used on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP platforms. For in vitro diagnostic use in the quantitative determination of total homocysteine (HCY) in serum or plasma. Lot #/Exp. Date: 88D1524 01 Jun 2014 88D3303 26 Nov 2013 Class II ADVIA Centaur Homocysteine dilution recovery on the diluent identified the percent recovery for the 1:10 patient sample dilutions lower than reported in the Instructions for Use (IFU). Siemens Healthcare Diagnostics, Inc
Food Jardines 7J Queso Amarillo (Item#50100) ; label: Jardine's 7J Ranch Queso Amarillo Cheese Dip; Mild; NET WT. 16 OZ (453g); Jardine Foods, Inc.; #1 Chisolm Trail, Buda, Texas 78610; Product of U.S.A. Lot Codes R-248-13, R-301-13, O-274-13, J-339-13, J-008-14, H-031-14 Class II Undeclared wheat due to supplier's inadvertent use of a wheat product instead of whey in preparing the cheese premix for the recalling firm. Jardine Foods Inc
Food DL Jardines Queso Loco (Item#R5230) ; Label: Special Edition D. L. Jardine's Texas Ranch Recipes Queso Loco Cheese Salsa & Dip; Medium; NET WT. 16 OZ (453g); Jardine Foods, Inc.; #1 Chisolm Trail, Buda, Texas 78610; Product of U.S.A. Lot Codes R-261-13, S-261-13, Q-261-13, H-331-13, N-274-13, F-031-14, G-031-14, N-017-14 Class II Undeclared wheat due to supplier's inadvertent use of a wheat product instead of whey in preparing the cheese premix for the recalling firm. Jardine Foods Inc
Food Mi Queso, Su Queso (Item#50440) ; Label: Jardine's 7J Ranch Mi Queso, Su Queso; Medium; NET WT. 16 OZ (453g); Jardine Foods, Inc.; #1 Chisolm Trail, Buda, Texas 78610; Product of U.S.A. Lot Codes T-261-13, I-339-13, H-031-14, M-021-14 Class II Undeclared wheat due to supplier's inadvertent use of a wheat product instead of whey in preparing the cheese premix for the recalling firm. Jardine Foods Inc
Food HT Traders Medium Queso (Item#HT510) ; Label: Medium Queso; Premium Salsa; Net Wt. 16 oz. Distributed by Harris Teeter, Matthews, NC Lot Codes Q-301-13, P-301-13, L-315-13, K-315-13, L-315-13 Class II Undeclared wheat due to supplier's inadvertent use of a wheat product instead of whey in preparing the cheese premix for the recalling firm. Jardine Foods Inc
Food Three Compadres Gift Box containing a varying combination of three Jardine products in 16 oz. glass jars. Some Gift Boxes included one jar of either Jardine's 7J Ranch Mi Queso, Su Queso (See Product #3) or one jar of Queso Loco Cheese Salsa & Dip (See Product #2) Gift Box Lot Codes: Y-284-13, Z-276-13, Z-305-13, Y-305-13, W-325-13, V-329-13, W-343-13, Z-345-13, Z-007-14, Y-014-14, Y-030-14, Y-030-14, Q-035-14 Class II Undeclared wheat due to supplier's inadvertent use of a wheat product instead of whey in preparing the cheese premix for the recalling firm. Jardine Foods Inc
Devices The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary grid. It contains signaling electronics to indicate the presence of the grid and detector as well as detector orientation. It may be mounted to a wall stand or incorporated in a radiographic table. *** US Devices Only *** 1) Part ID: 17007; Serial Numbers: WO171240/E-1, WO171240/E-2. 2) Part ID: 17009; Serial Numbers: WO165307/E-1 , WO165308/E-1 , WO170263/E-1 , WO172341/E-1 , WO172341/E-1 , WO172760/E-1 , WO172760/E-2 , WO174533/E-2 , WO174980/E-2 , WO175009/E-1 , WO175010/E-2 , WO175011/E-1 , WO175011/E-2 , WO175013/E-1 , WO175013/E-2 , WO177682/E-1 , WO187248/E-1 , WO191933/E-2. 3) Part ID: 17675; Serial Numbers: WO160580/E-1 , WO166945/E-1 , WO166945/E-2 , WO166946/E-1 , WO166946/E-2 , WO166949/E-1 , WO166949/E-2 , WO166950/E-1 , WO166951/E-1 , WO166952/E-1 , WO166952/E-2 , WO166954/E-1 , WO166954/E-2 , WO166955/E-1 , WO166955/E-2 , WO166957/E-1 , WO166957/E-2 , WO169388/E-1 , WO169388/E-2 , WO172050/E-1 , WO172050/E-2 , WO172051/E-1 , WO172051/E-2 , WO172345/E-1 , WO174072/E-2 , WO175014/E-1 , WO175014/E-2 , WO175015/E-1 , WO175993/E-2 , WO179503/E-1 , WO182220/E-1. 4) Part ID: 17676; Serial Numbers: WO160452/E-1 , WO160453/E-1 , WO165325/E-1 , WO166958/E-1 , WO166958/E-2 , WO166961/E-1 , WO166962/E-1 , WO166962/E-2 , WO166963/E-1 , WO166963/E-2 , WO166964/E-1 , WO166968/E-1 , WO166968/E-1 , WO166968/E-2 , WO166969/E-1 , WO166970/E-1 , WO166970/E-2 , WO167440/E-1 , WO167440/E-2 , WO169398/E 2 , WO169398/E-1 , WO169400/E-1 , WO169400/E-2 , WO169402/E-1 , WO171077/E-1 , WO171077/E-2 , WO171390/E-1 , WO171390/E-2 , WO171391/E-1 , WO171391/E-2 , WO172052/E-1 , WO172052/E-2 , WO172054/E-1 , WO172054/E-2 , WO174099/E-2 , WO175166/E-1 , WO175166/E-2 , WO175169/E-1 , WO175169/E-2. 5) Part ID: 17985; Serial Numbers:  ...
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Class II Harmony1 models of the Harmony Bucky is incorrectly labeled in that the label does not list the manufacturer address, the date of manufacture, or a statement of compliance with 21 CFR Subchapter J. Claymount Assembli
Devices The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary grid. It contains signaling electronics to indicate the presence of the grid and detector as well as detector orientation. It may be mounted to a wall stand or incorporated in a radiographic table. It is intended to be used in general radiographic applications as a component of a radiographic system. *** US Devices Only *** 1) Part ID: 17360; Serial Numbers: WO186722/E-1 , WO196470/E-1 , WO198534/E-1. 2) Part ID: 17361; Serial Numbers: WO186723/E-1. 3) Part ID: 17362; Serial Numbers: WO186724/E-1 , WO196360/E-1 , WO198545/E-2. 4) Part ID: 18476; Serial Numbers: WO196188/E-1 , WO196188/E-2 , WO196189/E-2. 5) Part ID: 18477; Serial Numbers: WO198547/E-1. 6) Part ID: 18479; Serial Numbers: WO198552/E-1. Class II Claymount Assemblies BV is recalling the Harmony2 model of Harmony Bucky because 1) the devices are incorrectly labeled in that the label does not list the manufacturer address, the date of manufacture, or a statement of compliance with 21 CFR Subchapter J, and 2) the device's insulation values do not comply with IEC 60601-1 in all cases. Claymount Assembli
Veterinary LifeShield LATEX-FREE HemoSet 100 mL Burette I.V. PlumSet, Nonvented, 105 inch with Prepierced Reseals, OPTION-LOK and Inline Dual Channel Cassette Product List Number: 112410403; Lot Numbers: 280055H, 341005H Class II Hospira identified an incorrect lower lid (set component) had been supplied and was being used during the manufacturing process of list number 11241-03, a Hemoset containing a burette and blood filter, intended for infusion of blood/blood products. In a gravity delivery, the correct lower lid dispenses 15 drops per mL and the incorrect lower lid found dispenses 10 drops per mL. Hospira Inc.
Food Lao Thai Nam Number One Sompa Salted Fish, Net Wt 7 oz. (198 g), Produced by Lao Thai Nam, 4444 W. Illinois Ave., Ste 400a, Dallas, TX 75211, UPC 8 84332 00019 4 All product distributed prior to 03/31/14. Class II The product has the potential to be contaminated with Clostridium botulinum. Lao Thai Nam Corporation
Food Fresh Wild Gulf Amberjack (Whole, Fillet and Portion) PLU: 29216300000, 29641800000 and 29712400000 Class II Firm received complaints of illness after consumption of Amberjack fish. Whole Foods Market South Seafood Distribution
Food Yangban Rice Porridge with Abalone, Net Wt. 10.16 oz (288 g), UPC 8 83298 61617 3, 24 cans/case Lot#: 2015-01-24 Class II HK Galleria Wholesale is recalling Rice Porridge with Abalone because it may be contaminated with Clostridium botulinum. HK GALLERIA WHOLESALE L.P
Devices Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for use in capturing images of the retina and anterior segment of the eye. Distributed by Nidek, Inc, and Marco Opthalmic Inc. Manufactured by Nidek Co. Ltd, Japan. Model AFC-330: Serial numbers: 380034 380021 380035 380061 380060 380013 380011 380069 380073 380053 380055 380067 380077 380078 380017 380075 380032 380080 380081 380092 380116 380120 380237 380238 380239 380240 380241 380122 380121 380014 380211 380125 380126 380127 380124 380215 380214 380188 380221 380187 380190 380189 380212 380062 380038 380128 380223 380224 380076 380216 380213 380222 380243 380054 380042 380225 380244 380251 380252 380256 380015 380250 380074 380018 380012 380258 380068 380260 380186 380037 380253 380264 380242 380261 380262 380123 380255 380016 380052 380033 380257 380259 380004 380009 380019 380023 380027 380029 380099 380101 380103 380108 380118 380131 380134 380139 380144 380146 380147 380148 380152 380153 380155 380156 380157 380159 380160 380162 380164 380175 380177 380178 380185 380196 380198 380201 380203 380207 380208 380218 380219 380236 380008 380020 380043 380056 380058 380063 380066 380070 380071 380088 380090 380098 380102 380105 380106 380107 380111 380112 380115 380117 380119 380129 380130 380136 380140 380141 380142 380143 380145 380150 380158 380163 380176 380179 380180 380181 380182 380183 380184 380199 380200 380202 380205 380209 380210 380226 380227 380228 380230 380232 380233 380234 380235 380265 380267 380268 380269 380270 380271 380272 380273 380274 380275. Class II Image taken by AFC-330 has a white spot which may affect diagnosis or evaluation of image. Nidek Inc
Devices Manual Resuscitator Bag Series: AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT4000, BT5000, BVM700, CPRM1000, CPRM2000, CPRM3000, PRO-1900, PRO-1000, PRO-2000, SC7000, SC8000, SC8020, SC8120, SC9000, SS3200, VN2000, VN3000, VN4000, VN5000, VT1000 , VN2102, VN2002. Emergency manual resuscitator for the Pediatric Population. Manual Resuscitator Bag Series: AF1000, AF2000, AF5000, BT4000, VN2000, VN5000, VT1000; Lot  ...
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Class I The pop-off valve in the defective devices remain open and a squeeze of the bag may not generate enough force to force the duck bill valve open and therefore no air will be delivered to the victim. Ventlab LLC
Biologics Red Blood Cells W084214000622; Class III Blood product, collected from a donor with polycythemia vera, was distributed. LifeSource
Biologics Red Blood Cells Leukocytes Reduced W287814000681; W288014001185; Class III Blood product, collected from a donor with polycythemia vera, was distributed. LifeSource
Biologics Red Blood Cells Leukocytes Reduced W038214022806; Class II Blood product, possibly contaminated with air during collection, was distributed. Kentucky Blood Center Inc
Biologics Red Blood Cells Leukocytes Reduced W036810045282; 2636839; Class II Blood products, collected from an unsuitable donor, were distributed. OneBlood, Inc.
Biologics Cryoprecipitated AHF 2441866 Class II Blood products, collected from an unsuitable donor, were distributed. OneBlood, Inc.
Biologics Platelets Pooled Leukocytes Reduced W036810806232; W036809820278; 2936933; 2928314; 2916439; 2913066; 2906808; Class II Blood products, collected from an unsuitable donor, were distributed. OneBlood, Inc.
Biologics Red Blood Cells W036809309525; 2601294; 2548618; 2416053; 2441866; 2375673; 2219900; 2219323; 2163158; 1465285; Class II Blood products, collected from an unsuitable donor, were distributed. OneBlood, Inc.
Biologics Fresh Frozen Plasma W036810045282; W036809309525; 2601294; 2548618; 2375673; 1465285; Class II Blood products, collected from an unsuitable donor, were distributed. OneBlood, Inc.
Biologics Red Blood Cells Leukocytes Reduced W071213017758; Class III Blood product, which failed to meet the minimum specification for red blood cell percent recovery, was distributed. Medic Inc
Biologics Platelets Pheresis Leukocytes Reduced W1151140597688; W1151140597688; Class II Blood products, for which the monthly product quality control was outside the acceptable range, were distributed. Lifesouth Community Blood Centers - Montgomery Region
Biologics Red Blood Cells Leukocytes Reduced W035213079119X; Class II Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed. Carter BloodCare
Biologics Cryoprecipitated AHF 1500157; W280313100569; W280313100571; W280313301453; W280313401141; W280313501433; W280313501435; W280313604358; W280313604371; W280310402161; W280310600246; W280310600268; W280310600287; W280310600288; W280311300170; W280312202000; W280312401013; W280312501718; W280312501719; W280312501720; W280312501721; W280313600506; 1500156; 2006316; 2006318; 2006391; 2006593; 2006594; 3501868; 3501869; 3501870; 3502243; 3502244; 3503146; 3504714; Class III Blood products, processed more than eight hours after collection, were distributed. Upstate New York Transplant Services
Devices Stirling Ultracold Portable Shuttle, ULT-25. Storage for cold-chain management, short-term or long-term ultra-low and storage and transport of biological specimens. Codes: ULT-25-255 & ULT-25-713 Class II The external power supply input is overheating at the connection to the freezer. Global Cooling Inc
Devices Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number 585006 contained in Alcon Assembly Numbers 9795-37, 11233-14, and 13334-04. The product is typically inserted through an incision during cataract surgery to deliver balanced salt solution to help anterior chamber space and replace fluids that are lost during surgery. Alcon Assembly Numbers 9795-37, 11233-14, and 13334-04 bearing Lot numbers 1584114H, 1577346H, 1595079H, 1589608H, 1595079H, 1585992H, 1580988H, 1585992H, and 1580492H. Class II Alcon CUSTOM-PAK which is supposed to contain a 27G Anterior Chamber Cannula (27G x 7/8 in) actually contains a 27G Sharp Tip Needle Alcon Research, Ltd.
Devices Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413  Simplexa" Flu A/B & RSV Direct. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C. Model Number: MOL2650. All Lot Numbers. The expiration date of the 614 kits of MOL2650 that are impacted by this Correction ranges from 10/31/2014 to 5/31/2015. Class II Focus Diagnostics is providing an urgent safety notice for a correction to the labeling for Simplexa" Flu A/B & RSV Direct (MOL2650). Focus Diagnostics received some customer complaints of Simplexa Flu A/B & RSV Direct assays with sporadic false signals, which may result in a higher false results rate due to a potential software spectral matrix and Direct Amplification Disc storage. Focus Diagnostics Inc
Biologics Red Blood Cells Leukocytes Reduced W127014612174; Class II Blood product, contaminated with air was distributed. OneBlood, Inc.
Biologics Red Blood Cells Leukocytes Reduced W088414514031; Class II Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed. Blood Bank Of Hawaii
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W043211032426; W043211032426; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Blood Assurance Inc
Biologics Source Plasma 9160122331; 9160123078; Class III Blood products, collected from a donor who did not have a complete medical history interview, were distributed. Cangene Plasma Resources, Inc.
Biologics Red Blood Cells Leukocytes Reduced W202213011188; Class II Blood product, which tested positive for Fyb red cell antigen, but was previously typed as negative for Fyb antigen, was distributed. American National Red Cross, Penn Jersey Region
Biologics Source Plasma 9160120103; 9160128389; Class III Blood products, collected from a donor who did not have a complete medical history interview, were distributed. Cangene Plasma Resources, Inc.
Biologics Red Blood Cells Leukocytes Reduced W053514000339; Class II Blood product, collected from a donor who emigrated from a malarial endemic area, was distributed. Central Jersey Blood Center, Inc.
Devices Siemens Mobilett XP Digital Mobile X-ray System Product Usage: The Mobilett XP and Mobilett XP Hybrid are radiographic systems designed for use in wards, intensive care, and premature birth-wards, pediatric and emergency departments, operating theatres as well as the central X-ray department. model no. 1818447, with serial nos.: 3284 3449 1026 1025 1010 1041 1054 2002 2058 2022 Class II There is a potential fire hazard of certain Lithium-Ion batteries in the computers used in the original manufacturing or as spare parts between October 2010 and April 2011 for the Siemens Mobilett XP Digital mobile X-ray System, which might occur at any time with higher probability while the system is being charged and connected to the main power supply. Siemens Medical Solutions USA, Inc
Devices Synthes B37 Replacement Screws. M3.5 Screw for insertion handle guide/aiming arm, part numbers 3.113.025 and 03.113.026. Surgical instrument for use with Low Bend Medial Distal Tibia Plate. Orthopedic. All lots of part no. B37: 6350586, 6771518, 7086318, 7386422, 7523960, and 7548937. Class II All lots of B37 Replacement Screws are being recalled due to potential mislabeling where the package may not contain the screws identified on the label. Synthes, Inc.
Food Ocean's Catch RTE Fresh Hand Picked Crabmeat , Net WT. 6 oz. plastic container Ingredients; Contains Jonah Crab Meat lot number 101366 with a sell by date before 5/14/14; lot number 101507 with a sell by date before 5/20/14; lot number 101540 with a sell by date before 5/21/14 Class I Product contaminated with Listeria monocytogenes Rome Packing Co., Inc.
Food Ocean's Catch RTE All Natural Jonah Crab Combo Meat Fresh Hand Picked Crabmeat , Net WT. 8 oz. and 16 oz. plastic container Ingredients; Contains Jonah Rock Crab Meat, Salt 8oz :containers: lot number 101372 with a sell by date before 5/14/14; lot number 101432 with a sell by date before 5/19/14; lot number 101474 with a sell by date before 5/20/14; 16 oz containers: "lot number 101372 with a sell by date before 5/14/14; "lot number 101391 with a sell by date before 5/16/14; "lot number  ...
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Class I Product contaminated with Listeria monocytogenes Rome Packing Co., Inc.
Food Ocean's Catch Jonah Crab Minced Meat Crabmeat , Net WT. 10 lb. plastic bag Lot 101450 Class I Product contaminated with Listeria monocytogenes Rome Packing Co., Inc.
Food Physique Enhancing Science ALPHAMINE, Powerful Thermogenic Powder, DIETARY SUPPLEMENT Net Wt. 8.9 oz (252 g). Raspberry Lemonade and Fruit Punch flavors. For Both Flavours the Lot #s are: N09474, N08447-B, N08448, N08447-A, N07398, and N07397. For Both Flavours the UPC #'s are: 793573113870 and 793573113801. Class II Products contain "Aegeline" an unapproved New Dietary Ingredient. Physique Enhancing Science
Food Physique Enhancing Science ENHANCED, Ultra Advanced Pre-Workout, DIETARY SUPPLEMENT Net Wt. 5.22 oz (148 g). In BlueRazz and Fruit Punch flavors For Both Flavors the Lot #s are: N01046, N01047, M11588, and M11589. For Both Flavours the UPC #s are: 793573173171, 793573221834, and 793573173140. Class II Products contain "Aegeline" an unapproved New Dietary Ingredient. Physique Enhancing Science
Devices DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of positive air pressure. Used in home and clinical environments. Model # DV51D-HH DV53D-HH DV53D-HH-S DV54D-HH DV54D-HH-S DV55D-HH DV55D-HH-S DV55D-S DV57D-HH serial numbers KD012316 JD034349 JD034384 JD034389 HD070335 HD070339 HD070352 HD070357 HD070377 HD070379 HD070395 HD071128 HD071138 HD071154 HD071278 HD070474 HD070736 JD034560 JD034566 HD070219 HD070162 HD070172 HD070174 HD070178 HD070182 HD070827 HD070961 HD071003 HD071004 HD071007 HD071009 HD071020 HD071021 HD071022 HD071030 HD071032 HD071033 HD071040 HD071043 HD071045 HD071048 HD071057 HD071058 HD071059 HD071062 HD071063 HD071064 HD071065 HD071069 HD071072 JD034492 JD034497 JD034504 JD034506 JD034507 JD034540 JD034543 JD034553 JD034554 JD034555 HD071068 JD034316 JD034317 JD034327 JD034328 JD034329 JD034330 JD034331 JD034332 JD034333 JD034334 HD070167 HD070171 HD070177 HD070190 HD070191 HD070198 HD070206 HD070212 HD070223 HD070225 HD070248 HD070249 HD070279 HD069902 HD069903 HD069906 HD069907 HD070533 HD070534 HD070545 HD070548 HD070563 HD070598 HD070605 JD034598 JD034599 JD034601 JD034603 JD034604 HD070724 HD070749 HD070756 HD070758 HD070760 HD070763 HD070767 HD070779 HD070781 HD070783 HD070787 HD070797 JD034569 JD034571 JD034576 JD034578 JD034586 JD034588 JD034591 JD034592 JD034597 HD069969 HD070722 HD070728 HD070733 HD070761 HD070784 JD034519 JD034602 JD034609 JD034613 JD034614 kd014347 HD069922 HD069905 HD069916 HD069917 JD034156 JD034158 JD034159 JD034163 JD034165 JD034185 JD034186 KD014349 KD014350 JD034209 JD034212 JD034231 JD034235 JD034239 JD034242 JD034584 JD034587 JD034589 JD034568 JD034581 JD034582 HD070283 HD070301 JD034161 JD034171 HD069927 HD069929 HD069930 HD069932 HD069949 HD069951 JD034211 JD034226 KD014329 HD070482 HD070483 HD070500 HD070556 HD070719 HD070720 HD070791 HD070800 HD070828 ID039134 ID039150 ID039167 KD014117 JD034402 KD014229 JD034154 JD034155 JD034160 JD034183 JD034188 JD034189 JD034190 JD034192 JD034193 JD034197 JD034221 JD034224 JD034229 JD034230 JD034232 JD034233 JD034162 JD034217 JD034236 JD034237 JD034240 JD034241 JD034244 JD034391 JD034392 JD034393 JD034394 JD034398 JD034405 JD034409 JD034410 JD034411 JD034412 JD034413 JD034414 KD014261 KD014301 KD014302 KD014307 KD014310 HD070617 HD070620 HD070626 HD070630 ID039143 HD070995 HD070802 HD070805 HD070813 HD070819 HD070825 HD070919 HD069941 HD070948 HD070773 HD070790 HD070864 HD070869 HD070947 HD070834 HD070836 HD070852 HD070859 HD070949 HD070950 HD070527 HD070635 HD070636 HD070637 HD070638 HD070639 HD070640 HD070591 HD070606 HD070623 HD070633 JD034500 JD034508 JD034509 JD034512 JD034521 JD034523 JD034524 JD034605 JD034610 JD034611 KD014187 KD014188 KD014189 KD014260 KD014263 KD014268 KD014270 KD014285 MD003233 MD003244 HD070962 HD070966 HD070968 HD070969 HD070990 JD034498 JD034499 JD034533 JD034544 HD070976 HD070977 HD070982 HD070985 HD071100 HD071102 HD071103 HD071104 HD071105 HD071106 HD071107 HD071111 HD071112 HD071113 HD071114 HD071115 HD071117 HD071118 HD071119 HD071120 JD034418 JD034419 JD034423 KD014348 KD014124 HD070410 HD070373 HD070388 JD034202 JD034206 JD034207 JD034223 JD034757 JD034758 JD034761 JD034762 HD070988 HD071084 JD034627 JD034629 JD034630 JD034658 JD034666 JD034671 JD034749 JD034752 HD069895 HD069896 HD069897 HD069898 HD069899 HD069928 HD069931 HD069933 HD069934 HD069937 HD069939 HD069942 HD069955 HD069957 HD069966 HD069993 HD069999 HD070001 JD034361 JD034364 HD070502 HD070503 JD034399 JD034401 HD070741 HD070765 HD070768 HD070777 HD070785 HD070788 JD034434 JD034452 HD070612 HD070613 HD070973 HD069936 HD069946 HD069948 HD069952 HD069959 HD069961 HD069963 HD069972 HD069994 HD069997 HD070569 HD070570 HD070571 HD070572 HD070573 HD070574 HD070575 HD070577 HD070579 HD070582 HD070590 HD070592 HD070593 HD070611 HD070625 HD070830 HD070831 HD070832 HD070833 HD070865 HD070866 HD070867 HD070868 HD070870 HD070871 HD070872 HD070873 HD070874 HD070875 HD070876 HD070878 HD070879 HD070881 HD070883 HD070884 HD070885 HD070886 HD070889 HD070890 HD070891 HD070929 HD070930 HD070837 HD070838 HD070839 HD070840 HD070842 HD070843 HD070844 HD070845 HD070848 HD070849 HD070850 HD070851 HD070853 HD070854 HD070855 HD070856 HD070858 HD070860 HD070861 HD070951 HD070952 HD070953 HD070954 HD070955 HD070956 HD070957 HD070958 HD070959 HD070960 HD070971 HD070264 HD070277 HD070263 JD034198 JD034200 JD034203 JD034210 JD034214 JD034215 JD034218 JD034219 JD034225 JD034227 JD034228 JD034234 KD014300 KD014238 HD069935 HD069938 HD069943 HD069945 HD069947 HD069954 HD069958 HD069975 HD069983 HD069984 HD069985 HD069987 HD069989 HD069990 HD069991 HD069992 HD069995 HD069996 HD069998 HD070000 JD034751 HD070354 HD070466 HD070318 HD070320 HD070338 HD070348 HD070349 HD070350 HD070365 HD070368 HD070369 HD070370 HD070372 HD070375 HD070385 HD070389 HD070390 JD034167 HD070963 KD014226 KD014221 KD014336 KD014327 HD069921 HD069926 KD014116 KD014119 KD014120 KD014121 KD014125 HD069900 HD069904 HD069919 HD069924 HD069925 HD069908 HD069909 HD069910 HD069911 HD069912 HD069913 HD069915 HD070505 HD070507 HD070509 HD070512 HD070516 HD070622 HD070624 HD070628 HD070632 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KD014259 KD014266 KD014280 KD014123 JD034196 JD034213 KD014192 KD014216 HD070311 HD070428 HD070435 HD070451 HD070461 HD070463 HD070207 KD014344 HD070829 HD070764 HD070794 JD034375 HD070609 HD069780 JD034152 JD034164 HD070267 HD070268 HD070270 HD070273 JD034208 JD034153 HD070169 HD070170 HD070176 HD070180 HD070183 HD070184 HD070185 HD070186 HD070187 HD070188 HD070196 HD070197 HD070204 HD070205 HD070208 HD070222 HD070226 HD070227 HD070228 HD070230 HD070232 HD070233 HD070235 HD070236 HD070238 HD070239 HD070242 HD070243 HD070245 HD070246 HD070506 HD070510 JD034565 JD034577 HD070738 HD070792 HD070793 HD070972 HD070981 HD070993 JD034628 JD034647 HD069950 HD069953 HD069956 HD069976 HD069977 HD069978 HD069979 HD069980 HD070274 HD070287 HD070288 HD070290 HD070298 HD070300 HD070476 HD070478 HD070260 HD070271 HD070286 HD070752 HD070759 HD070136 HD070139 HD070142 HD070132 HD070134 HD071026 HD071051 HD071053 HD071055 HD071056 HD071067 HD071071 HD071073 HD070602 HD070603 HD070604 HD070607 HD070608 HD070614 HD070615 HD070616 HD070618 HD070627 HD070214 HD070217 HD070256 HD070257 HD070262 KD014223 HD070215 HD070250 HD070265 HD070181 HD070199 HD070211 KD014299 HD069914 JD034182 JD034187 HD070588 HS133216 HS133217 HS133218 HS133219 HS133220 HS133221 HS133222 HS133223 HS133224 HS133225 HS133226 HS133227 HS133228 HS133229 HS133230 HS133231 HS133232 HS133233 HS133234 HS133235 JS014835 JS014837 JS014838 JS014839 JS014840 JS014841 JS014842 JS014843 JS014844 JS014845 JS014846 JS014847 JS014848 JS014849 JS014850 JS014851 JS014852 JS014853 JS014854 JS014856 HD070578 HD070581 HD070583 HD070584 HD070587 HD070597 HD070599 HD070600 JD034335 JD034340 JD034343 JD034345 JD034346 JD034355 JD034358 JD034359 JD034360 JD034363 KD014230 KD014232 KD014233 KD014234 KD014235 KD014236 KD014237 KD014245 HS133236 HS133237 HS133238 HS133239 HS133242 HS133243 HS133244 HS133245 HS133246 HS133247 HS133240 HS133241 HS133248 HS133249 HS133250 HS133251 HS133252 HS133253 HS133254 HS133255 HS133256 HS133257 HS133258 HS133259 HS133260 HS133261 HS133262 HS133263 HS133264 HS133265 HS133266 HS133267 HS133268 HS133269 HS133270 HS133271 HS133272 HS133273 HS133274 HS133275 HS133276 HS133277 HS133278 HS133279 HS133280 JS014808 JS014809 JS014816 JS014817 JS014855 JS014857 JS014858 JS014859 JS014860 JS014861 JS014862 JS014863 JS014864 JS014865 JS014866 JS014867 JS014868 JS014871 JS014873 JS014874 JS014875 JS014876 JS014877 JS014878 JS014879 JS014880 JS014881 JS014882 JS014883 JS014884 JS014885 JS014886 JS014887 JS014902 JS014903 KD014257 KD014267 KD014294 KD014295 KD014296 KD014297 KD014304 KD014305 KD014311 KD014313 ID039102 ID039103 ID039108 ID039110 ID039113 ID039115 ID039117 ID039120 ID039121 ID039122 ID039123 ID039124 ID039128 ID039132 ID039133 ID039135 ID039138 ID039139 ID039140 ID039145 ID039146 ID039147 ID039148 ID039151 ID039154 ID039155 ID039156 ID039160 ID039162 ID039164 ID039165 ID039169 ID039170 ID039171 ID039172 ID039175 ID039177 ID039178 ID039180 JD034502 JD034510 JD034511 JD034513 JD034514 JD034515 JD034607 JD034608 JD034736 JD034737 JD034738 JD034739 JD034740 JD034741 JD034743 JD034746 JD034759 JD034760 JD034765 JD034766 HD070491 HD070494 HD070496 HD070499 HD070501 HD070504 HD070525 HD070530 HD070531 HD070532 HD070541 HD070542 HD070543 HD070544 HD070549 HD070550 HD070551 HD070552 HD070555 HD070558 HD070559 HD070560 HD070564 HD070485 HD070487 HD070488 HD070489 HD070565 HD070567 HD070568 Class III A limited number of DV5x Series CPAP units were manufactured and shipped without the serial number programmed into the unit, causing the unit serial number on LCD display to appear as "RUN-TEST". DeVilbiss Healthcare LLC
Devices syngo® Lab Data Manager syngo Lab Data Manager Application Software versions VA11B, VA12A, and VA12B Class II Certain configuration parameters may cause the reference ranges to not hold results as expected and release them to the Laboratory Information System (LIS) that should have been held for manual review. Siemens Healthcare Diagnostics, Inc.
Devices illumipro-10 Incubator/Reader, Meridian Bioscience, Inc. The illumipro-10 incubator/reader is designed to be used with illumigene Molecular Assays. The device incubates illumigene Test Devices and reads endpoint reactions. Serial Numbers: IP2669, IP2670, IP2671, IP2672, IP2673, IP2674, IP2675, IP2676, IP2677, IP2678, IP2680, IP2682, IP2683, IP2684, IP2685, IP2686, IP2687, IP2688, IP2689, IP2690, IP2691, IP2692, IP2693, IP2694, IP2695, IP2696, IP2697, IP2698, IP2699, IP2700, IP2701, IP2702, IP2703, IP2704, IP2705, IP2706. Class II Illumipro-10 instruments may have Block B chambers operating at an incorrect temperature as a result of incorrect temperature calibration. Meridian Bioscience Inc
Biologics Platelets Pooled Leukocytes Reduced W204214003913; Class III Blood products, collected from a donor who reported a post donation illness, were distributed. American National Red Cross
Biologics Blood and Blood Products for Reprocessing W204214003913; Class III Blood products, collected from a donor who reported a post donation illness, were distributed. American National Red Cross
Devices Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N. Autotransfusion Apparatus. Lot Number: 10906458 Class II Product that was previously recalled because the Chest Drain tubing of the ATS Blood recovery may leak or disconnect, was released for distribution in error. Atrium Medical Corporation
Biologics Platelets Pheresis Leukocytes Reduced W088414201425; Class II Blood product, collected from a donor whose health history was not adequately performed, was distributed. Blood Bank Of Hawaii
Biologics Platelets Pheresis Leukocytes Reduced W398514024786A; W398514024786A; Class II Blood product, labeled as leukoreduced which did not meet the requirements for a leukoreduced product, was distributed. Community Blood Center of Carolinas
Food Large Pitted Kalamata Olives, packaged in 4.4lb black plastic barrels. Labeling reads in part: Savor Greek Large Pitted Kalamata Olives, refrigerate after opening, these olives are mechanically pitted and may contain pit fragments, DR WT 4.4LBS (2kg) Lot Code: SIRA D 0224, UPC: 6 84476 03790 8 Class II This voluntary recall has been initiated because Savor Brands Large Pitted Kalamata Olives may contain glass. Dot Foods Inc.
Food Brunkow Cheese of Wisconsin, Monterey Jack Morel Mushroom & Onion Cheese, 5 lb block plastic wrapped and vacuum sealed. Eight blocks per case. Ingredients: Cultured Pasteurized Whole Milk, Salt, Microbial Enzymes, Morel Mushroom and Onion. Lot numbers: 112014 010114 010414 042914 060314 080314 090514 100514 111214 Class III Brunkow Cheese of Wisconsin is recalling Monterey Jack Morel Mushroom Cheese because the product is mislabeled. The product contains other type of mushroom instead of Morel Mushrooms as listed on the label. Brunkow Cheese of Wisconsin, Inc.
Food Rosemary & Olive Oil Gluten Free Snack Crackers sold under the following brand names and sizes: 1. glutino, Net Wt. 4.25 oz (120g) UPC 78523-03861; 2. glutino, 2 count 10 oz bags, Net Wt. 20 oz (566 g) UPC 78523-03863; 3. Aldi's brand live G free, Net Wt. 4.25 oz (120g) UPC 41498-20371 Lot Code 11914 / Best ByDate 10-26-14, and Lot Code 14314 / Best By Date 11-24-14 Class I A seasoning supplier is recalling its rosemary and olive oil seasoning blend, which potentially may be contaminated with Salmonella. Baptista's Bakery, Inc
Devices NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 1. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis. Size 1, includes the following Lot numbers: 37217848 61424993 61507222 61543969 61774117 62141262 62193298 62251564 62261955 62383353 62602809 62602810 62602811 Class II Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification. Zimmer Manufacturing B.V.
Devices NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 2. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis. Size 2, includes the following Lot numbers: 37214650 61417415 61417416 61442278 61459938 61459939 61459940 61488069 61497510 61497511 61518148 61518149 61538023 61543972 61543973 61543974 61567335 61592049 61592050 61627189 61627190 61672554 61672555 61672556 61672557 61672558 61682128 61682129 61721665 61721666 61721667 61774118 61774119 61774120 61827109 61827110 61827111 61863080 61863081 61863083 61863084 61863085 61912434 61915370 61915371 61979021 61979022 61979023 62016175 62020276 62041296 62060610 62069533 62091728 62141255 62141256 62141257 62155305 62155306 62155307 62177111 62214660 62214661 62214662 62214663 62214664 62251565 62251566 62271420 62298567 62315723 62319301 62326315 62337922 62337923 62345561 62345562 62377649 62383365 62411732 62411733 62411735 62411736 62411737 62586465 62586467 62610913 62610914 62640980 62646141 62646142 Class II Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification. Zimmer Manufacturing B.V.
Devices NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 3. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis. Size 3, includes the following Lot numbers: 370316 37214039 61414610 61414611 61442294 61442295 61442296 61442297 61450963 61450964 61450965 61454951 61454952 61454953 61459941 61459942 61475123 61475124 61488064 61488065 61488066 61488067 61488068 61497512 61497513 61507223 61507224 61518151 61518153 61518154 61526398 61526399 61558358 61558359 61558360 61558361 61567336 61567337 61567338 61567339 61592084 61592085 61592086 61592087 61627191 61627192 61627193 61627194 61627195 61627196 61627197 61627198 61627199 61627201 61627202 61643928 61643929 61643930 61643931 61643932 61658872 61658873 61658874 61658875 61658876 61658877 61672561 61672562 61672563 61672564 61672565 61672566 61721668 61721669 61721670 61774134 61774135 61774136 61774137 61774140 61774141 61774142 61827112 61827113 61827114 61827115 61827116 61863088 61863090 61863091 61863093 61863094 61898777 61898778 61898779 61898780 61898781 61912437 61914863 61914864 61914865 61934678 61934679 61934680 61934681 61934682 61958855 61958856 61958857 61958858 61979024 61979025 61979026 61979027 61993771 61993773 61993774 61993775 61993776 62022557 62029925 62029926 62029927 62037892 62041300 62041301 62041302 62060611 62060612 62064931 62064932 62064933 62069538 62077846 62077847 62077848 62080358 62080359 62080360 62143198 62143199 62143201 62143601 62143602 62143603 62168181 62168182 62193299 62193301 62193302 62193303 62200277 62200278 62200279 62214665 62214666 62214667 62214668 62214669 62227415 62227416 62227417 62271422 62271423 62271424 62271425 62271426 62284606 62284607 62284608 62298568 62298569 62319299 62326502 62326503 62332546 62332547 62335852 62335864 62345560 62352633 62352634 62357204 62357205 62377654 62377655 62383356 62383357 62389590 62389591 62389592 62423838 62423839 62423840 62454586 62454587 62460233 62460234 62462894 62462895 62465729 62465730 62465731 62473291 62473292 62473294 62525438 62525439 62525440 62528591 62528592 62528593 62528594 62528595 62610905 62610906 62610907 62610908 62610909 62640971 62640972 62640973 62640974 62640975 62646143 62646144 62646145 62649650 62649652 62649653 62649655 Class II Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification. Zimmer Manufacturing B.V.
Devices NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 4. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis. Size 4, includes the following Lot numbers: 370317 37214651 37218726 37219271 37220949 61417419 61417420 61442307 61442308 61442309 61442310 61442311 61450966 61451221 61451222 61459957 61459958 61475125 61475126 61475127 61475128 61488208 61488209 61488210 61488211 61518162 61518163 61518164 61526401 61538046 61543975 61543976 61558363 61567340 61567341 61567342 61567343 61592088 61592089 61627203 61627204 61627205 61627206 61643933 61643934 61658878 61658879 61658880 61658881 61658882 61678232 61678233 61682153 61682154 61682155 61692238 61692240 61721671 61721672 61721673 61774143 61774144 61774145 61774146 61774147 61774148 61827117 61827118 61827119 61863112 61863113 61863114 61863115 61863116 61912438 61914866 61914867 61914868 61914869 61934684 61934685 61934686 61934687 61958859 61958860 61958861 61979028 61979029 61979030 62016156 62016157 62016158 62022554 62022555 62029928 62029929 62029930 62041303 62041304 62060613 62060614 62064935 62064936 62077849 62077850 62077851 62143194 62143195 62143196 62143197 62143604 62143605 62143606 62143607 62168183 62168184 62193304 62193305 62193306 62200285 62200286 62214670 62214671 62214672 62227418 62227419 62261960 62261961 62261962 62261963 62261964 62261966 62315724 62319295 62319296 62319297 62326311 62326312 62332564 62332565 62345558 62345559 62358488 62358490 62363649 62377650 62383363 62383364 62390066 62390067 62390068 62454576 62454577 62454578 62465724 62465725 62465726 62473212 62473213 62473215 62528582 62528583 62586506 62586507 62586509 62586510 62586518 62610915 62610916 62640976 62640977 62640978 62640979 62646146 62646147 62649656 62649658 Class II Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification. Zimmer Manufacturing B.V.
Devices NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 4+. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis. Size 4+, includes the following Lot numbers: 61424996 61459959 61475129 61538052 61563971 61573791 61573792 61592090 61627207 61685463 61721674 61774165 61863139 61870152 61934692 61935096 61979044 61979045 62020278 62064940 62091727 62214673 62251567 62251568 62319307 62337924 62369795 62401020 62423841 62436412 62471736 62602816 62646169 Class II Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification. Zimmer Manufacturing B.V.
Devices NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 5. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis. Size 5, includes the following Lot numbers: 370318 37214652 61424997 61442318 61442319 61442320 61451223 61454955 61454956 61459968 61459969 61459970 61475130 61475131 61475132 61488234 61518182 61518183 61518184 61526402 61543977 61567344 61567345 61592091 61592092 61627258 61627260 61643935 61643936 61658884 61658885 61658886 61774178 61774179 61774180 61774181 61774182 61774183 61863148 61863149 61863150 61863151 61863152 61912439 61934688 61934689 61935101 61935102 61979031 61979032 61979033 62016160 62016162 62022559 62037894 62037895 62051524 62051525 62069546 62089014 62089015 62143608 62168185 62177112 62193308 62200281 62200282 62200283 62214674 62214675 62227420 62261968 62261972 62261973 62261975 62298570 62332566 62352641 62358491 62358492 62377651 62423843 62455679 62460240 62460242 62460243 62525441 62525442 62586581 62586582 62610910 62610911 62610912 62640982 62646149 62646150 Class II Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification. Zimmer Manufacturing B.V.
Devices NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 6. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis. Size 6, includes the following Lot Numbers: 370319 37213647 37218135 37218727 37219556 37220950 61414605 61414606 61442322 61451224 61451225 61451226 61479488 61479489 61479490 61518197 61518198 61518199 61538053 61543978 61592093 61592094 61627261 61643938 61672569 61682157 61685470 61721675 61721676 61774189 61774190 61774191 61774195 61863158 61863159 61863160 61863161 61863162 61979034 61979035 62016163 62022560 62037896 62041306 62041308 62069549 62077856 62141261 62143609 62168186 62177113 62227421 62227422 62251569 62251570 62261977 62261978 62326316 62330687 62341281 62369796 62369797 62377652 62473295 62473296 62602804 62602805 62602806 62602807 62602808 Class II Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification. Zimmer Manufacturing B.V.
Devices NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 7. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis. Size 7, includes the following Lot Numbers: 370320 37214653 61424998 61442326 61459971 61459972 61488229 61518205 61543979 61658887 61658888 61827120 61827121 61827122 61979040 61979041 62051526 62091729 62200288 62227423 62251572 62330688 62383359 62383362 62401016 62401017 62602812 62602813 62640983 Class II Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification. Zimmer Manufacturing B.V.
Devices NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 8. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis. Size 8, includes the following Lot numbers: 370321 37213648 37216196 61424999 61543980 62029931 62390069 Class II Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification. Zimmer Manufacturing B.V.
Food Ocean Spray® Greek Yogurt Covered Craisins® Dried Cranberries , 8 oz Resealable Pouch UPC: #23719 Best By Dates: Feb 10, 2015 and Feb 11, 2015 Class I Product contains undeclared peanuts Ocean Spray Cranberries Inc.
Devices CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs monitoring for multiple patients. Model Number: CNS-6201 Software Version 02-26 only. Serial Numbers: 00485, 00488, 00489, 00490, 00491, 00361, 00429, 00430, 00432, 00436, 00443, 00447, 00478, 00486, 00546, 00564, 00573, 00574, 00575, 00576, 00592, 00626, 00638, 00643, 00651, 00674, 00675, 00677, 00678, 00679, 00687. Class II Software Version 02-26, when used with the Central Nursing Station (CNS) 6201, (PU-621 RA) may unexpectedly and without warning reboot, resulting in a period of approximately 3 minutes during which time the system does not display patient data and does not emit alarms based on that data should they be appropriate. Nihon Kohden America Inc
Biologics Blood and Blood Products for Reprocessing W204913020188; Class III Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed. American National Red Cross SW Region - HT
Biologics Red Blood Cells W085114000397; Class II Blood product, which failed the residual white blood cell count and labeled as leukoreduced, was distributed. Central Blood Bank
Biologics Red Blood Cells Leukocytes Reduced W039414106570; Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. OneBlood, Inc.
Biologics Red Blood Cells Leukocytes Reduced W039414106569; Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. OneBlood, Inc.
Food Roselani Tropics Kona Mud Mud Pie Ice Cream: 1.75QT, - 56 oz. carton. Maui Soda & Ice Works, Ltd. Wailuku, HI Lot/Expiration date: 05/08/2015 Class II Complaint received of a carton of Roselani Tropics Kona Mud Pie Ice Cream that was filled with chocolate Macadamia Nut Ice Cream. Maui Soda & Ice Works Ltd/dba Roselani Ice Cream
Food waxed paperboard int container of frozen ice cream labeled Thrifty Ice Cream Mint 'N' Chip 1 Pint (16 Fl. OZ.) Bottom of container Expiration Date: October 28 2015 Lot #24273 Back of container UPC 1182264327 Expiration Date: October 28 2015 Lot #24273 Class I Pistachio flavored ice cream was inadvertently packed into 16 oz. (Pint) containers labeled as Thrifty Ice Cream Mint 'N' Chip. Ingredient statement does not declare pistachio. Rite Aid HDQTRS. Corp.
Food Ferrous Gluconate Tablets, 5gr (325 mg), Elemental Iron 36 mg, 100 Tablets, UPC 0 79854 50032 5 Lot No. 3KB01 and 3LB72 Class II National Vitamin is recalling Nature's Blend Ferrous Gluconate Tablets because they are mislabeled on the front panel with 65 mg of elemental iron. The side panel and the tablets inside the bottle have the correct label with 36mg of elemental iron per tablet. National Vitamin Co Inc
Food Kirkland Signature Coarse Ground Malabar Pepper, 12.7 oz Plastic Jars, UPC 096619164998. Packaging includes a PET bottle. The lid is made of Polypropylene and contains a tinplate insert and a Polypropylene five-hole cap. The label on the jar is a rectangular label (front and back) information is superimposed over an antique map in various shades of brown. Lot #: OT 065099, OT 065169, OT 065254, OT 065255, OT 065256, and OT 065284. Class I Olde Thompson is recalling Kirkland Signature Coarse Ground Malabar Black Pepper because it may be contaminated with Salmonella. Olde Thompson, Inc.
Devices System Manual for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System. Part numbers 550120 for standard; 550516 for S system and 550650 for Si System. Class II Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release Wrench, part number 710142. Intuitive Surgical, Inc.
Devices Endowrist Instrument and Accessory Manual for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System. Part number 550675 Class II Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release Wrench, part number 710142. Intuitive Surgical, Inc.
Devices Vision Troubleshooting Guide for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System. Part number 550866 Class II Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release Wrench, part number 710142. Intuitive Surgical, Inc.
Devices Insert for IRK for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System. Part number 550973 Class II Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release Wrench, part number 710142. Intuitive Surgical, Inc.
Devices Stapler Addendum for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System. Part number 550986 Class II Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release Wrench, part number 710142. Intuitive Surgical, Inc.
Devices Vessel Sealer Addendum for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System Part number 551027 Class II Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release Wrench, part number 710142. Intuitive Surgical, Inc.
Devices Vessel Sealer QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System. Part number 551182 Class II Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release Wrench, part number 710142. Intuitive Surgical, Inc.
Devices Single Site US Manuals and Single Site OUS Manuals for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System. Part number 551184 - US Manual; Part number 550965 - OUs manuals. Class II Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release Wrench, part number 710142. Intuitive Surgical, Inc.
Devices IRK QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System and Si-e. Intuitive Surgical Endoscopic Instrument Control System Part number 551979 - da Vinci S, Si and SI-e Part number 551980 - da Vinci Standard. Class II Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release Wrench, part number 710142. Intuitive Surgical, Inc.
Devices Cautery QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic Instrument Control System Part number 551992. Class II Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release Wrench, part number 710142. Intuitive Surgical, Inc.
Devices Connection QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System. Part number 551993. Class II Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release Wrench, part number 710142. Intuitive Surgical, Inc.
Devices Natural Rubber Latex QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System. Part number 551997. Class II Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release Wrench, part number 710142. Intuitive Surgical, Inc.
Biologics Blood and Blood Products for Reprocessing W115913271239; W115912235161; Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD) were distributed. Central California Blood Center
Biologics Red Blood Cells Leukocytes Reduced W115913271239; W115912235161; Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Central California Blood Center
Devices Stride Femoral Component Size 2, PFSI-00053, Right Lateral /Left Medial. Unicondylar Knee prosthesis. Lot C785231, Exp 5-2015 Class II Mislabeled. Packages labeled PFSI-00053, Right Lateral/Left Medial contains PFSI-00054, Right Medial/Left lateral implants. Packages labeled PFSI-00054, Stride Right Medial/Left Lateral contain PFSI-00053, Left Medial/Right Lateral. Blue Belt Technologies MN
Devices Stride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral. Unicondylar Knee prosthesis. Lot C785241, Exp 4-2015 Class II Mislabeled. Packages labeled PFSI-00053, Right Lateral/Left Medial contains PFSI-00054, Right Medial/Left lateral implants. Packages labeled PFSI-00054, Stride Right Medial/Left Lateral contain PFSI-00053, Left Medial/Right Lateral. Blue Belt Technologies MN
Devices Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions Langston Dual Lumen Pressure Monitoring catheter is used as a pressure measurement catheter and for delivery of contrast media during angiographic studies. Lot Numbers: 569436, 569437, 569962, , 569963, 569964, 569965, 570177, 570178, 570337, 570338, 570339, 570340, 570341, 570504, 570505, 570506, 570507, 570592, 570593, 570674, 570675, 570744, 570745, 570746, 570836, 570926, 570927, 570928, 570929, 571099, 571100, 571101, 571102, 571103, 571350, 571412, 571413, 571414, 571415, and 571727. Class I The inner catheter of some Langston V2 Dual Lumen Catheters have separated from the device hub during contrast pressure injections. This may require an intervention to retrieve the separated piece from the patient to prevent injury. Vascular Solutions, Inc.
Devices BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for use in In vitro Diagnostics. FACS Canto: model number 657338; Associates Fluidic Cart (catalog number 6657660)- IVD; Serial numbers: V65733800001, V65733800002, V65733800003, V65733800004 V65733800005, V65733800006, V65733800007, V65733800008, V65733800009, V657338000010, V657338000011, V657338000012, V657338000013, V657338000014, V657338000017, V657338000018, V657338000019, V657338000020, V657338000021, V657338000022, V657338000023, V657338000024, V657338000025, V657338000026, V657338000028, V657338000029, V657338000031, V657338000032, V657338000033, V657338000034, V65733800035, V65733800036, V65733800037, V65733800038, V65733800039, V657338000040 V657338000043, V657338000044, V657338000045, V657338000046,  ...
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Class II Laser cooling fans and internal fan of the associated fluidics cart are not operational. BD Biosciences, Systems & Reagents
Food Dole Garden Soup "Roasted Garlic Tomato Basil", Net Wt. 26 oz. (1lb 10oz) 737 g, UPC 3890002404, 6 units/case Lot No. WF14113 and WF14114, Best By Oct 23 2015 and Oct 24 2015 Class I Dole Packaged Foods is recalling Dole Garden Soup Roasted Garlic Tomato Basil because it contains undeclared milk. Dole Packaged Foods, Llc
Devices Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips Ref 3221 Lot Numbers: 00115342 Class II Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw Microline Surgical, Inc.
Devices Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips (Reusable) Ref 3222 Lot Numbers: Lot Number 00115282 Lot Number 00115283 Lot Number 00115284 Lot Number 00115340 Lot Number 00115341 Lot Number 00115501 Lot Number 00115502 Lot Number 00115865 Lot Number 00116277 Lot Number 00116278 Class II Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw Microline Surgical, Inc.
Devices Anspach Pneumatic and Electric Motor Systems. Intended for cutting and shaping bone, including the spine and cranium. DFU: 18-0047: Revisions A & B 18-0074: Revision A; and 18-0105: Revisions A. Operating Manuals: 19-0010: Revisions A, and 19-0013: Revisions A, B, & C. Class II Several attachments and handpieces failed to meet the expected sterility assurance level (SAL) when sterilized by the method that is specified in the current Directions for Use (DFU) provided with the device. The Anspach Effort, Inc.
Devices MIS Rod 2, a component of the NewPort System Model No: 60-0545 (45mm); 60-0550 (50mm); 60-0555 (55mm); 60-0560 (60mm); 60-0575 (75mm); 60-0580 (80mm). The NewPort MIS Rod 2 is a 5.5 diameter titanium spinal rod used to immobilize adjacent NewPort pedicle screws. Lot No. Z21781A (45mm NewPort MIS Rod, 2) Z21956A (50mm NewPort MIS Rod, 2) Z21782A (55mm NewPort MIS Rod, 2) Z21957A (60mm NewPort MIS Rod, 2) Z21784A (75mm NewPort MIS Rod, 2) Z21958A (80mm NewPort MIS Rod, 2) Class II Integra Lifesciences is recalling NewPort System MIS Rod, 2 because it may be up to 30 degrees offset from specification requirements causing misalignment with the inserter. This could potentially result in the lordosis of the rod not aligning with the handle when the inserter is used in accordance with the current NewPort MIS System Surgical Technique. Integra LifeSciences Corp.
Devices Stryker Orthopaedics Triathlon Tritanium Patella Inserter, . NON-STERILE Product Usage: The Triathlon Tritanium Patella Inserter is part of the Tritanium Knee System Instrument Set. It is used to implant the Tritanium Patella after the patellar bone has been prepared using the existing Triathlon Patella Resection Guide, Metal Backed Patella Drill and Patella Peg Drill Templates as per the Triathlon Tritanium Surgical Protocol. Catalog No. 6541-3-530. Lot Codes: CTD2778 and CTD2779. Class II Tritanium Patella Inserter Instrument fracture during implantation. . Stryker Howmedica Osteonics Corp.
Food Sharp Cheddar Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 8 ounce cups with snap-on lid (14001), 14 ounce cups with snap on lid (17001), 10 lb. pail with snap on lid (12341). 2. Central Markets in 8 oz cups with snap on lid (27056). 3. Cobblestone Market in 5 lb. pail (42403) with snap on lid. 8. Dierks Waukesha in 5 lb. pail with snap on lid (11442) Sell by Date: 2/17/2015, 5/20/2015, and 5/21/2015 Class II Parkers Farm is recalling cheese and salsa products that may be contaminated with Listeria monocytogenes. This action is being taken as a precaution in response to testing conducted by the Minnesota Department of Agriculture. Parkers Farm Inc
Food Port Wine Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 8 ounce (14010), 14 ounce (17010), and 5 lb. (11951) white tub with snap on lid; 2. 150+Central Markets in 8 oz cups with snap on lid (27057). 3. Cobblestone Market in 5 lb. pail pails with snap on lid (42503). 4. Dierks Waukesha in 5 lb. pail with snap on lid (11952). Sell by Date: 2/17/2015, 5/20/2015, and 5/21/2015 Class II Parkers Farm is recalling cheese and salsa products that may be contaminated with Listeria monocytogenes. This action is being taken as a precaution in response to testing conducted by the Minnesota Department of Agriculture. Parkers Farm Inc
Food Olivia Swan Cheddar Cold Pack Cheese 10 lb. pail with snap on lid (12341os) Sell by Date: 2/17/2015 Class II Parkers Farm is recalling cheese and salsa products that may be contaminated with Listeria monocytogenes. This action is being taken as a precaution in response to testing conducted by the Minnesota Department of Agriculture. Parkers Farm Inc
Food Horseradish Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 10 lb. pail with snap on lid (42550); 2. Cobblestone Market in 5 lb. pail pails with snap on lid (42603). Sell by Date: 2/17/2015 Class II Parkers Farm is recalling cheese and salsa products that may be contaminated with Listeria monocytogenes. This action is being taken as a precaution in response to testing conducted by the Minnesota Department of Agriculture. Parkers Farm Inc
Food Mild Salsa sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 16 ounce (51305) container with snap on lid. Sell by Date: 9/19/2014 Class II Parkers Farm is recalling cheese and salsa products that may be contaminated with Listeria monocytogenes. This action is being taken as a precaution in response to testing conducted by the Minnesota Department of Agriculture. Parkers Farm Inc
Food Hot Salsa sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 16 ounce (51205) container with snap on lid. Sell by Date: 9/19/2014 Class II Parkers Farm is recalling cheese and salsa products that may be contaminated with Listeria monocytogenes. This action is being taken as a precaution in response to testing conducted by the Minnesota Department of Agriculture. Parkers Farm Inc
Food Fire Roasted Salsa sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 16 ounce (51605) container with snap on lid. Sell by Date: 9/19/2014 Class II Parkers Farm is recalling cheese and salsa products that may be contaminated with Listeria monocytogenes. This action is being taken as a precaution in response to testing conducted by the Minnesota Department of Agriculture. Parkers Farm Inc
Food Garlic Salsa sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 16 ounce (51505) container with snap on lid. Sell by Date: 9/19/2014 Class II Parkers Farm is recalling cheese and salsa products that may be contaminated with Listeria monocytogenes. This action is being taken as a precaution in response to testing conducted by the Minnesota Department of Agriculture. Parkers Farm Inc
Drugs Isoniazid Tablets, USP, 300 mg, Rx only, packaged in a) 100-count bottles, NDC 0143-1261-01, b) 1000-count bottles, NDC 0143-1261-10, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724; c) 30-count bottles, NDC 61748-013-30, d) 100-count bottles, NDC 61748-013-01, e) 1000-count bottles, NDC 61748-013-10, Mfd. for: VersaPharm Incorporated, Marietta, GA 30062; Mfd. by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724. Lot #: a) 67839A, 67839D, Exp 05/14; 67936A, Exp 02/15; b) 67839B, 67840C, Exp 05/14; 67936B, Exp 02/15; c) 67840A, Exp 05/14; d) 67840B, Exp 05/14; e) 67839C, Exp 05/14 Class II Failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 month time point. West-Ward Pharmaceutical Corp.
Devices Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Catalog No. 46913. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid (intrathecal) region. Lot No. 206923217 207096627 207096630 207187691 207224897 207269986 207466017 207565424 207565425 207659575 207659576 207739874 207875274 207945037 207982847 Class I Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconnected from the patient line stopcock. Medtronic Neurosurgery
Devices Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Catalog No. 46914. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid (intrathecal) region. Lot No. 206843112 206854300 206875578 206923218 206951123 206962974 206986677 207167084 207246210 207312741 207441171 207466011 207466012 207560684 207632971 207659577 207716835 207716836 207766493 207900255 207945036 207983301 208008802 Class I Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconnected from the patient line stopcock. Medtronic Neurosurgery
Devices Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, Catalog No. 46915. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid (intrathecal) region. Lot No. 206923344 206986678 207096628 207565426 207659574 207945035 207982846 208031201 208055143 Class I Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconnected from the patient line stopcock. Medtronic Neurosurgery
Devices Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, Catalog No. 46916. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid (intrathecal) region. Lot No. 206843114 206854302 206923345 207167085 207246211 207466015 207565607 207716842 207766492 208031202 Class I Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconnected from the patient line stopcock. Medtronic Neurosurgery
Devices Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, Catalog No. 46917. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid (intrathecal) region. Lot No. 208031203 Class I Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconnected from the patient line stopcock. Medtronic Neurosurgery
Devices EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EM1200 DY Display, Replacement EM 1200 DY Display. EXACTAMIX 2400 Compounder model numbers 2400-DY, 2400-DX, 2400-DYR and 2400-DYX. Baxa Corporation. An automated pumping system that compounds multiple sterile ingredients into a finished solution in a single patient IV administration bag. model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EXACTAMIX 2400 Compounder model numbers 2400-DY, 2400-DX, 2400-DYR and 2400-DYX Class II If the universal ingredient (UI) in an active configuration is changed using the Configuration Editor, a flush of the outlet pump tube will not be initiated by the software. It could result in the original UI remaining in the tube which could be delivered into the next bag. Baxter Healthcare Corp.
Devices Integra® LED Battery Charger, Single Bay. Product Number: 90523 The LED Headlight System Battery Charger (90523) is an accessory to the LED Headlight System: 90520US - LED Headlight w/Battery & AC/DC Power Supply - US 90520EU - LED Headlight w/Battery & AC/DC Power Supply - EU 90520UK - LED Headlight w/Battery & AC/DC Power Supply - UK 90520AU - LED Headlight w/Battery & AC/DC Power Supply - AU Product Usage: The Integra LED Headlight System Is designed to provide illumination to aid visualization during minor surgical, diagnostic, or therapeutic procedures Lot Numbers: IE123610, IE123710, IE123810, IE123910, IE124010, IE124110, IE124210, IE124310, IE124410, IE124510, IE124610, IE124710, IE124810, IE124910, IE125010, IE125110, IE125210, IE130110, IE130210, IE130310, IE130410, IE130510, IE130610, IE130710, IE130810, IE130910, IE131010 Class II LED battery chargers may prematurely fail and will not charge the LED battery as intended Integra LifeSciences Corp.
Devices ADVIA Centaur® Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708 and 02790309 (500 tests), SMN 10317790 Kit Lots Ending In: 078, 079, 082, 083, 084 Class II The solid phase reagent in some of the ADVIA Centaur® TnI -Ultra ReadyPacks®, lot 084, is darker in appearance, creating a potential for incorrect control and patient results. Siemens Healthcare Diagnostics, Inc
Devices MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge. Siemens Healthcare Diagnostics, Inc. in vitro diagnostic. WalkAway 40 - Material number: 10444853; catalog number: B1018-283; WalkAway 96 - Material number: 1044854, Catalog number B1018-284. Class II Springs contained in the access door hinge assembly on the Walk Away Plus instruments are becoming detached causing premature failure of the hinge assembly and a potential safety issue for the customers. Siemens Healthcare Diagnostics, Inc.
Devices GE Healthcare, Proteus XR/a. Proteus XR/a Intended Use: Is intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications. Mfg Lot or Serial # System ID 00000023354HL4 804289HDFER 00000017868HL1 801268ER 00000024445HL9 804747DHPER 00000018247HL7 972596PER3 00000021176HL3 804541ER 00000018523HL1 408977ER3 00000019915HL8 772468ER1 00000018898HL7 813571ERPRO 00000018576HL9 850747GCER 00000024536HL5 904391RAD1 00000019171HL8 561395RAD 00000020749HL8 773282TOMO8 00000034015HL8 847316PROER1 00000012567HL4 502868RAD2 00000017199HL1 972596OPRAD1 00000017648HL7 405271UPX1 00000032656HL1 407518PR1 00000041533HL1 580249SPRO2 00000022569HL8 614868PRO4 00000012718HL3 706257SFP 00000020559HL1 770748PER 00000033658HL6  ...
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Class II GE Healthcare has become aware of a potential safety issue due to a collimator installation error during a service maintenance activity involving the Proteus XR/a and Revolution XR/d X-ray imaging systems. . There was a reported incident of a collimator fall which caused a serious patient injury. GE Healthcare, LLC
Devices GE Healthcare, Revolution XR/d. Revolution XR/d Intended Use: The Revolution XR/d Digital Radiographic imaging system is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications. Mfg Lot or Serial # System ID 00000023354HL4 804289HDFER 00000017868HL1 801268ER 00000024445HL9 804747DHPER 00000018247HL7 972596PER3 00000021176HL3 804541ER 00000018523HL1 408977ER3 00000019915HL8 772468ER1 00000018898HL7 813571ERPRO 00000018576HL9 850747GCER 00000024536HL5 904391RAD1 00000019171HL8 561395RAD 00000020749HL8 773282TOMO8 00000034015HL8 847316PROER1 00000012567HL4 502868RAD2 00000017199HL1 972596OPRAD1 00000017648HL7 405271UPX1 00000032656HL1 407518PR1 00000041533HL1 580249SPRO2 00000022569HL8 614868PRO4 00000012718HL3 706257SFP 00000020559HL1 770748PER 00000033658HL6  ...
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Class II GE Healthcare has become aware of a potential safety issue due to a collimator installation error during a service maintenance activity involving the Proteus XR/a and Revolution XR/d X-ray imaging systems. . There was a reported incident of a collimator fall which caused a serious patient injury. GE Healthcare, LLC
Devices ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems. 10041461, 10440017 - S2000 system 10441730 - S3000 system 10441701 -S1000 system US Serial numbers: 206555 208590 208609 210104 210121 210187 210103 201296 201355 202477 206011 208663 210186 210172 210173 210178 210188 210257 200379 201754 202985 206249 206592 206715 206746 207626 207735 207737 207755 207940 207944 208654 208668 208718 208772  ...
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Class II There is a potential measurement error with the Auto-Stats (auto statistics) measurement tool on the ACUSON S Family ultrasound system. Siemens Medical Solutions USA, Inc.
Drugs Bystolic (nebivolol) tablets, 20 mg/tablet. 7 Tablet Professional Sample Bottle, Rx Only. Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, Missouri 63045. NDC 0456-1420-07. Lot # A308879, Expiry: 09/2015 Class II Failed Dissolution Specifications: Drug failed stage III dissolution testing. Forest Pharmaceuticals Inc
Devices Laceration Trays, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc., Arden, NC. Model number: 68350, Lot numbers: 187146, 187341, 187150 & 187148, Exp. Date: 12/01/2016; Model number: 58168, Lot number: 187212, Exp. Date: 11/1/2016; Model number: 68297B, Lot number: 187196, Exp. Date: 12/1/2016 and Model number: 72851B, Lot number: 187208, Exp. Date: 12/1/2018. Class II Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Medical Action Industries Inc
Devices Laceration/Suture Removal, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC. Model number: 72347, Lot number: 187172, Exp. Date: 9/1/2015. Class II Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Medical Action Industries Inc
Devices Suture Set, Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC. Model number: 58468B, Lot number: 187203, Exp. Date: 11/1/2016. Class II Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Medical Action Industries Inc
Devices Port-A-Cath Tray, Stage One: Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC. Model number: 58647B, Lot number: 187175, Exp. Date: 12/1/2015. Class II Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Medical Action Industries Inc
Devices Max Barrier Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC. Model number: 70828, Lot number: 187176, Exp. Date: 1/1/2016. Class II Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Medical Action Industries Inc
Devices Safety Laceration Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC. Model number: 59108B, Lot number: 187210, Exp. Date: 2/1/2017. Class II Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Medical Action Industries Inc
Devices McKesson Medi-Pak, Laceration Trays with Cotton O.R. Towels, Sterile, Single Use, Latex Free, 20 Each per Case, Rx only, Distributed by: McKesson Medical Surgical, Inc., Richmond, VA 23228 Model number: 25-2685, Lot number: 187211, Exp. Date: 12/1/2016. Class II Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Medical Action Industries Inc
Devices Laceration Kit: W/Needles, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC. Model number: 68718, Lot number: 187198, Exp. Date: 12/1/2016. Class II Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Medical Action Industries Inc
Drugs Brevibloc Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2,500 mg/250 mL (10 mg/mL), 250 mL Single Use IntraVia container, packaged in 10 x 250 mL Single Use IntraVia containers per carton, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1415, NDC 10019-055-61. Lot #: C926923, Exp 01/16 Class II Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating. Baxter Healthcare Corp.
Devices Name: Pasteur Pipets, used by the embryologist in the IVF Laboratory. Model numbers: PP-5.75-90 PP-9-90 PP-5.75-90PL PP-9-90PL CODE: Model #s: PP-5.75-90, PP-9-90, PP-5.75-90PL, PP-9-90PL. Lots with labeled expiry date of May 2, 2015, or later. Class II Identification of packaging breach of the nylon pouch sterile barrier for the 3-pack configuration ORIGIO, Inc
Veterinary Frozen mice in ziplock bags There is no code information. The package shows the type of mice and the quantity. Class II The firm imitated a voluntary recall of frozen mice intended for use as reptile feed because of possible human exposure to Lymphocytic Choriomeningitis Virus from handling the mice. Steve Pritchett Farms LLC
Drugs Mometasone 0.6 mg /60 mL Irrigation solution, 4000 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045 Lot # / Beyond Use Date: 04282014@11 / BUD 05/28/14; 04212014@4 / BUD 05/21/2014 Class II Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent. Brookfield Prescription Center Inc. dba MD Custom Rx
Drugs Diphenhydramine (Alcohol Base) 25 mg / 0.5 mL Solution, 30 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045 Lot # / Beyond Use Date: 05012014@36 / 05/15/14 Class II Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent. Brookfield Prescription Center Inc. dba MD Custom Rx
Drugs HCG (Human Chorionic Gonadotropin) 125 units/ 0.1 mL drop, 5 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045 Lot # / Beyond Use Date: 05192014@15 / BUD 07/18/14; 04142014@39 / BUD 6-13-14; 04182014@4 / BUD 6-17-14; 04162014@12 / BUD 06/15/14; 05092014@34 / BUD 07/08/14; 04162014@35 / BUD 06/15/14; 05232014@33 / BUD 07/22/14; 05022014@36 / BUD 7/1/14;  ...
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Class II Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent. Brookfield Prescription Center Inc. dba MD Custom Rx
Drugs HCG 125U/Tab Tablet Tritu, 50 tablets per bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045 Lot # / Beyond Use Date: 05022014@5 / BUD 07/01/14; 04032014@7  ...
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Class II Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent. Brookfield Prescription Center Inc. dba MD Custom Rx
Drugs HCG (Human Chorionic Gonadotropin) 200 units/ 0.1 mL drops, packaged in 5 mL and 10 mL bottles, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045 Lot # / Beyond Use Date: 04232014@49 / BUD 06-22-14; 04232014@2 / BUD 06/22/14; 04252014@27 / BUD 06/24/14; 04162014@33 / BUD06/15/14; 05132014@2 / BUD 07/12/14; 05092014@39 BUD 7-8-14 Class II Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent. Brookfield Prescription Center Inc. dba MD Custom Rx
Drugs HCG (Human Chorionic Gonadotropin) + Methylcobalamin (Methyl B12), 1500 units + 1000 mcg/mL drop, 8 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045 Lot # / Beyond Use Date: 04302014@21 / BUD 06/29/14 Class II Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent. Brookfield Prescription Center Inc. dba MD Custom Rx
Drugs Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, Rx only, Packaged in 30 Count and 90 Count Bottles. Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India. 30-Count Bottle NDC: 41616-758-83, 90-Count Bottle: NDC 41616-758-81. 30 Count Bottle: Lot #: JKL5054A, Expiry: 08/2014; Lot #: JKM2305A, Expiry: 03/2015. 90 Count Bottle: Lot #: JKL5054B, Expiry: 08/2014; Lot #: JKM2305B, Expiry: 03/2015. Class II Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications. Caraco Pharmaceutical Laboratories, Ltd.
Devices Baxter, MiniCap with Povidone-Iodine solution, 5C4466P. For dialysis. Lot Numbers: GD894535, GD894550 Class II the white printed paper layer on the pouch packaging may not be fully adhered to the pouch foil layer. The upper paper layer may serve as a protective barrier and help support overall packaging. Baxter Healthcare Corp.
Devices BrightView XCT: product code 882482, BrightView X- upgraded with the XCT Flat Panel Detector (FPD): product code 882454. Gamma camera for Single Photon Emission Computed Tomography (SPECT). Medical Device for imaging. BrightView XCT: product code 882482 BrightView X- upgraded with the XCT Flat Panel Detector (FPD): product code 882454 All Codes:, , 6000305,6000306,6000307,6000308,6000309,6000310,6000311,6000312,6000313,6000314, Class II Flat Panel Display (FPD) failed to remain securely locked in the deployed position. Philips Medical Systems (Cleveland) Inc
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