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U.S. Department of Health and Human Services

Enforcement Report - Week of November 14, 2012

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Devices Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3300E/ER The Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures. Serial Numbers: 330001-330069, 330071, 330072, 330074, 330075. Class II Sechrist conducted a field upgrade on the hyperbaulic chambers equipped with Electronic Control Modules in order to correct a software bug that could potentially affect the performance of the chamber. Sechrist Industries Inc
Devices Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3600E/ER The Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures Serial Numbers: 360001-360049, 360051-360064, 360068. Class II Sechrist conducted a field upgrade on the hyperbaulic chambers equipped with Electronic Control Modules in order to correct a software bug that could potentially affect the performance of the chamber. Sechrist Industries Inc
Devices Quadra S Offset Broach Handle The offset broach handle is intended to attach to the broaches of different sizes as the surgeon broaches the femoral bone in preparation for the implantation of the femoral stem. Ref: 01.10.10.122 (Lot # 085119), Ref: 01.10.10.123 (Lot # 085120), Ref: 01.10.10.124 (Lot # 085244), Ref: 01.10.10.125 (Lot # 085243) Class II Medacta USA Inc has initiated a recall on the Quadra S Offset Broach Handle because of the potential of the rivet that locks the metallic wire to the lever may become loose during a surgery and make it impossible to lock/unlock the broaches. Medacta Usa Inc
Drugs Northstar Zolpidem Tartrate Tablets USP 10 mg. Manufactured for Northstar RX, LLC Memphis, TN 38141. Manufactured by Aurobindo Pharma Limited, Unit VII, Mahaboob Dagar, 509302, India Batch Number ZPSB11054-A Exp. 05/13 Class II Adulterated Presence of Foreign Tablets: This product is being recalled becaiuse 30 valacyclovir hydrochloride tablets USP 500 mg were discovered in a bottle labeled Zolpidem Tartrate tables USP 10 mg Aurobindo Pharma LTD
Devices R-30H , Diagnostic X-Ray Beam-Limiting Device. In combination with any of below X-ray tubes 0.6/1.2P364DK-85, 0.6/1.2P324DK-125, 0.6/1.2P324DK-85, 0.6/1.2P38DE-85 Device Model # R-30H. Subsequent Product Code: IZX Product Usage: The device is the beam-limiting device for X-ray Radiography. Device Model #R-30H Class II Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m) Beam quality --(1) Half-value layer (HVL), which was revised in 2006. Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006. Shimadzu Medical Systems
Devices R-20J , Diagnostic X-Ray Beam-Limiting Device. In combination with any of below X-Ray tubes: 06/1.2P364DK-85, 0.6/1.2P324DK-125, 06/1.2P324DK-85, 0.6/1.2P38DE-85. Product Usage: The device is the beam-limiting device for X-ray Radiography. Device Model #R-20J Class II Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m) Beam quality --(1) Half-value layer (HVL), which was revised in 2006. Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006. Shimadzu Medical Systems
Devices 0.7U163CS-36 In combination with below systems MUX-100H, MUX-100D, MobileArt Evolution Brand Name: MUX-100H. Classification Name: Mobile x-ray system. Device Model#MUX-100H. Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. S/N of X-ray tube: 63049 63048 63074 63081 63082 63077 63350 63349 63629 63647 63909 62729 64214 66033 66032 70070 70065 70364 66327 66331 70058 66325 70955 71241 70920 71848 72472 72462 73056 73058 73341 73675 74577 74563 74565 74557 74558 74846 74845 75455 75452 75457 75728 75737 75736 76059 76057 76060 76054 76062 76360 76366 76612 76636 76336 76916 76655 76647 76938 76940 2XY080646 2XY0081249 2XY0081245 2XY0081543 2XY0081858 2XY0081849 2XY0081855 2XY0081856 2XY0081865 2XY0081862 2XY0082746 2XY0082764 2XY0083055 2XY0083052 2XY0083064 2XY0083051 2XY0083053 2XY0083038 2XY0083063 2XY0083063 2XY0083065 2XY0083343 2XY0083340 2XY0083349 2XY0083354 2XY0083360 2XY0083355 2XY0083646 2XY0083359 2XY0083652 2XY0083670 2XY0083674 2XY0083655 2XY0083673 2XY0083675 2XY0083665 2XY0083645 2XY0083643 2XY0083629 2XY0074577 2XY0083638 2XY0083943 2XY0083671 2XY0083933 2XY0083930 2XY0083925 2XY0084532 2XY0084558 2XY0084546 2XY0084553 2XY0084538 2XY0084846 2XY0084565 2XY0084845 2XY0085124 2XY0085137 2XY0085127 2XY0084578 2XY0085140 2XY0085143 2XY0085141 2XY0086351 2XY0084860 2XY0084856 2XY0084851 2XY0084859 2XY0086344 2XY0084852 2XY0086365 2XY0086364 2XY0086373 2XY0086368 2XY0086665 2XY0086674 2XY0087077 2XY0087371 2XY0087044 2XY0087036 2XY0087041 Class II Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m) Beam quality --(1) Half-value layer (HVL), which was revised in 2006. Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006. Shimadzu Medical Systems
Devices 0.7/1.3U163CS-36 In combination with below systems MobileArt Evolution, MobileDaRt Evolution Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. S/N of X-ray tube: 64510 66036 66026 66027 71866 70641 72470 72740 72735 73360 73365 2XY0084531 73372 73679 73671 73966 74248 74258 74546 74548 74291 74556 74832 74834 74833 74829 74837 76058 76326 76069 76355 76364 76361 76356 76358 76363 76367 2XY0080666 80666 2XY0080650 2XY0080345 2XY0080649 2XY0080656 2XY0082453 2XY0082456 2XY0082461 2XY0082748 2XY0083039 2XY0075448 2XY0082750 2XY0083070 2XY0082778 2XY0083047 2XY0083058 2XY0083680 2XY0083627 2XY0083633 2XY0083951 2XY0084556 Class II Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m) Beam quality --(1) Half-value layer (HVL), which was revised in 2006. Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006. Shimadzu Medical Systems
Devices 0.7/1.2JG326D-265 Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. MobileArt Evolution (12.5 kW) S/N of X-ray tube: 2XY0090049 2XY0090052 2XY0090062 2XY0090388 2XY0092824 2XY0092822 2XY0094944 2XY0094940 2XY0095628 2XY0095975 2XY0095996 2XY0097550 2XY0097539 2XY0000035 2XY0090058 MobileArt Evolution (32 kW) S/N of X-ray tube: 2XY0092847 2XY0092851 2XY0092850 2XY0093893 2XY0093890 2XY0093561 2XY0096822 2XY0096828 2XY0097579 2XY0000834 2XY0001079 2XY0001215 2XY0001200 2XY0001311 2XY0001216 2XY0001312 2XY0001214 2XY0001377 2XY0001374 2XY0001383 2XY0001488 2XY0001653 2XY0001478 2XY0001657 2XY0001658 2XY0001674 2XY0001672 2XY0001644 2XY0002081 2XY0002281 2XY0002088 2XY0002083 2XY0002289 2XY0001827 CM74B3012026 2XY0003774 2XY0004043 Class II Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m) Beam quality --(1) Half-value layer (HVL), which was revised in 2006. Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006. Shimadzu Medical Systems
Devices 0.4/0.7JG326D-265AX/AT Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. S/N of X-ray tube: 2XY0084725 2XY0084724 2XY0084723 2XY0099698 2XY0084726 2XY0084736 2XY0084739 2XY0084869 2XY0084729 2XY0084868 2XY0085162 2XY0085175 2XY0086383 2XY0086395 2XY0086726 2XY0086725 2XY0086724 2XY0087086 2XY0087088 2XY0087090 2XY0087421 2XY0087423 2XY0087427 2XY0087765 2XY0090747 2XY0091075 2XY0093894 2XY0096298 2XY0096820 2XY0096821 2XY0096832 2XY0096292 2XY0098245 2XY0098240 2XY0001064 2XY0001195 2XY0001088 2XY0001208 2XY0001077 2XY0001086 2XY0001198 2XY0001321 2XY0001204 2XY0001336 2XY0001337 2XY0001352 2XY0001388 2XY0001315 2XY0001370 2XY0001380 2XY0001464 2XY0001482 2XY0001484 2XY0001485 2XY0002730 2XY0003042 2XY0003037 2XY0003759 CM74B3016024 CM74B3017067 CM74B301201A CM74B3012018 CM74B3012017 CM74B301201C CM74B3012020 CM74B3012034 CM74B3012032 CM74B3013002 CM74B3016073 CM74B3016109 CM74B3015010 Class II Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m) Beam quality --(1) Half-value layer (HVL), which was revised in 2006. Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006. Shimadzu Medical Systems
Devices Sysmex XE-2100 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #983-1341-1 The Sysmex XE-2100 is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XE-2100 performs hematology analyses according to the RF/DC detection method, HydroDynamic Focusing (DC Detection), flow cytometry method (using a semiconductor laser), and SLS-hemoglobin method. catalog #983-1341-1, all serial numbers Class II There is a variation of reticulocyte counts between XE Series (XE-2100, XE-5000) and XT-Series (XT-2000i, XT-4000i) hematology analyzers that may result in a retic counts that are an average of 21% lower on the XE-Series because of a low bias. Sysmex America, Inc.
Devices Sysmex XE-5000 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #063-7591-7 The Sysmex XE-5000 is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XE-5000 performs analyses using the following methods: RF/DC Detection Method, Sheath Row DC Detection Method, and Flow Cytometry Methods using a Semiconductor Laser. Particle characterization and identification is based on detection of forward scatter, fluorescence and adaptive cluster analysis. Using the same reagents as the XE-2100, the XE-5000 automatically classifies cells from blood and body fluids and carries out all processes automatically from aspiration of the sample to outputting the results. catalog #063-7591-7, all serial numbers Class II There is a variation of reticulocyte counts between XE Series (XE-2100, XE-5000) and XT-Series (XT-2000i, XT-4000i) hematology analyzers that may result in a retic counts that are an average of 21% lower on the XE-Series because of a low bias. Sysmex America, Inc.
Devices Sysmex XE-2100C Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #053-2311-4 The Sysmex XE-2100C is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. catalog ##053-2311-4, all serial numbers Class II There is a variation of reticulocyte counts between XE Series (XE-2100, XE-5000) and XT-Series (XT-2000i, XT-4000i) hematology analyzers that may result in a retic counts that are an average of 21% lower on the XE-Series because of a low bias. Sysmex America, Inc.
Veterinary Land O Lakes, Pheasant Starter A Medicated, Type C Medicated Feed. Item # 1125000-301 L633 Class I Land O Lakes Purina LLC is recalling two batches of Pheasants Starter A Medicated feed produced on 6/13/12 and 7/2/12 because there was a formulation error and Vitamin D was omitted. Land O Lakes Purina LLC
Veterinary EXPANDED RECALL: PURINA HONOR SHOW CHOW BROILER COMP AMP 0.0125% BMD50 MEDICATED, NET WEIGHT 50 LBS (22.67 KG), PURINA MILLS, LLC, PO BOX 66812, ST. LOUIS, MO 63166-6812, UPC 8 83576 01124 9, 0016637, 781B. Lot Codes: , 2MAY23MFI1, 2JUN11MFI3, 2JUN12MFI1, 2JUN14MFI3, 2JUN20MFI3, 2JUN28MFI3, 2JUL06MFI1, 2JUL16MFI3 Class I Land O Lakes Purina LLC is recalling two batches of Pheasants Starter A Medicated feed produced on 6/13/12 and 7/2/12 because there was a formulation error and Vitamin D was omitted. Recall expanded 7-26-12 to include other products due to the lack of added vitamin D. Land O Lakes Purina LLC
Veterinary EXPANDED RECALL: PURINA HONOR SHOW CHOW TURKEY GROW/FINISH BMD50 PELLET MEDICATED, NET WEIGHT 50 LBS (22.67 KG), PURINA MILLS, LLC, PO BOX 66812, ST. LOUIS, MO 63166-6812, UPC 8 83576 01182 9, 801R,0017095. Lot Codes: 2MAY23MFI1, 2MAY31MFI1, 2JUN12MFI3, 2JUN20MFI3, 2JUN27MFI1, 2JUL06MFI1, 2JUL11MF13, 2JUL18MFI1 Class I Land O Lakes Purina LLC is recalling two batches of Pheasants Starter A Medicated feed produced on 6/13/12 and 7/2/12 because there was a formulation error and Vitamin D was omitted. Recall expanded 7-26-12 to include other products due to the lack of added vitamin D. Land O Lakes Purina LLC
Veterinary EXPANDED RECALL: PURINA HONOR SHOW CHOW TURKEY STARTER AMP .0125% BMD50 MEDICATED, NET WEIGHT 50 LBS (22.67 KG), PURINA MILLS, LLC, PO BOX 66812, ST. LOUIS, MO 63166-6812, UPC 8 83576 01183 6, 801T, 0017096. Lot Codes: 2MAY31MFI1, 2JUN06MFI3, 2JUN11MF13, 2JUN19MFI3, 2JUN22MFI3, 2JUL03MFI1, 2JUL11MF13, 2JUL13MFI1 Class I Land O Lakes Purina LLC is recalling two batches of Pheasants Starter A Medicated feed produced on 6/13/12 and 7/2/12 because there was a formulation error and Vitamin D was omitted. Recall expanded 7-26-12 to include other products due to the lack of added vitamin D. Land O Lakes Purina LLC
Veterinary EXPANDED RECALL: DUMOR SHOW POULTRY AMP .0125% BMD 50 MEDICATED, TRACTOR SUPPLY COMPANY, 200 POWELL PLACE, BRENTWOOD, TN 37027-6812, NET WEIGHT 40 LB (18.14 KG), UPC 7 49394 01890 0, 60VA, 0045400. Lot Codes: 2JUN11MFI3, 2JUL11MFI3, 2JUL18MFI1 Class I Land O Lakes Purina LLC is recalling two batches of Pheasants Starter A Medicated feed produced on 6/13/12 and 7/2/12 because there was a formulation error and Vitamin D was omitted. Recall expanded 7-26-12 to include other products due to the lack of added vitamin D. Land O Lakes Purina LLC
Veterinary EXPANDED RECALL: DUMOR CHICK STARTER 24%, TRACTOR SUPPLY COMPANY, 200 POWELL PLACE, BRENTWOOD, TN 37027-6812, NET WEIGHT 50 LB (22.67 KG), UPC 7 49394 05739 8, 60X7 , 0046443. Lot Codes: 2MAY30MFI1, 2JUN13NST1A1, 2MAY31STJ1, 2JUN13MFI1, 2JUN14NST1A1, 2MAY31STJ3, 2JUN22MFI1, 2JUN19NST2A1, 2JUN05STJ2, 2JUL11MFI3, 2JUN20NST2A1, 2JUN20STJ1, 2JUL02NST2A1, 2JUN26STJ2, 2JUL16NST2A1, 2JUL03STJ2, 2JUL16STJ2 Class I Land O Lakes Purina LLC is recalling two batches of Pheasants Starter A Medicated feed produced on 6/13/12 and 7/2/12 because there was a formulation error and Vitamin D was omitted. Recall expanded 7-26-12 to include other products due to the lack of added vitamin D. Land O Lakes Purina LLC
Veterinary EXPANDED RECALL: DUMOR POULTRY GROWER/FINISHER 15%, TRACTOR SUPPLY COMPANY, 200 POWELL PLACE, BRENTWOOD, TN 37027-6812, NET WEIGHT 50 LB (22.67 KG), UPC 7 49394 05737 4, 60Y7, 0046444. Lot Codes: 2MAY23MFI1, 2JUN07NST1A1, 2MAY25STJ1, 2MAY29MFI1, 2JUN12NST1A1, 2MAY25STJ3, 2MAY31MFI1, 2JUN13NST2A1, 2JUN05STJ2, 2JUN01MFI1, 2JUN18NST1A1, 2JUN18STJ2, 2JUN05MFI1, 2JUN20NST1A1, 2JUN21STJ2, 2JUN08MFI1, 2JUN21NST2A1, 2JUL03STJ2, 2JUN13MFI1, 2JUN27NST1A1, 2JUN14MFI1, 2JUN28NST2A1, 2JUN18MFI3, 2JUL05NST2A1, 2JUN20MFI3, 2JUL06NST2A1, 2JUN22MFI1, 2JUL13NST2A1, 2JUN29MFI1, 2JUL18NST1A1, 2JUN29MFI3, 2JUL09MFI3, 2JUL09MFI1, 2JUL17MFI3, 2JUL20MFI3 Class I Land O Lakes Purina LLC is recalling two batches of Pheasants Starter A Medicated feed produced on 6/13/12 and 7/2/12 because there was a formulation error and Vitamin D was omitted. Recall expanded 7-26-12 to include other products due to the lack of added vitamin D. Land O Lakes Purina LLC
Veterinary EXPANDED RECALL: PURINA DIAMOND MILLING 15% LAYER FEED 1.5 FLAX, 0041731, 60BQ, BULK NET WEIGHT, PURINA MILLS, LLC, PO BOX 66812, ST. LOUIS, MO 63166-6812. 60BQ Class I Land O Lakes Purina LLC is recalling two batches of Pheasants Starter A Medicated feed produced on 6/13/12 and 7/2/12 because there was a formulation error and Vitamin D was omitted. Recall expanded 7-26-12 to include other products due to the lack of added vitamin D. Land O Lakes Purina LLC
Veterinary EXPANDED RECALL: PURINA CU PRIVETT BREEDER STARTER 60KK, 0044485, BULK NET WEIGHT AND PURINA CU PRIVETT BREEDER GROWER, 60KL, 0044484, BULK NET WEIGHT PURINA MILLS, LLC, PO BOX 66812, ST. LOUIS, MO 63166-6812 60KK, 60KL Class I Land O Lakes Purina LLC is recalling two batches of Pheasants Starter A Medicated feed produced on 6/13/12 and 7/2/12 because there was a formulation error and Vitamin D was omitted. Recall expanded 7-26-12 to include other products due to the lack of added vitamin D. Land O Lakes Purina LLC
Veterinary EXPANDED RECALL: PURINA TURKEYMAX FINISHER 3 VMY 10 MEDICATED, 806G, 0045481, BULK NET WEIGHT, PURINA MILLS, LLC, PO BOX 66812, ST. LOUIS, MO 63166-6812 806G Class I Land O Lakes Purina LLC is recalling two batches of Pheasants Starter A Medicated feed produced on 6/13/12 and 7/2/12 because there was a formulation error and Vitamin D was omitted. Recall expanded 7-26-12 to include other products due to the lack of added vitamin D. Land O Lakes Purina LLC
Veterinary EXPANDED RECALL: PURINA CS PHEASANT GROWER AMP 0.0175% MEDICATED, 804A, 0038560, BULK NET WEIGHT, PURINA MILLS, LLC, PO BOX 66812, ST. LOUIS, MO 63166-6812 804A Class I Land O Lakes Purina LLC is recalling two batches of Pheasants Starter A Medicated feed produced on 6/13/12 and 7/2/12 because there was a formulation error and Vitamin D was omitted. Recall expanded 7-26-12 to include other products due to the lack of added vitamin D. Land O Lakes Purina LLC
Veterinary EXPANDED RECALL: PURINA CU LATHROP AN LAY 16 FLAX, 61XU, 0058755, BULK NET WEIGHT, PURINA MILLS, LLC, PO BOX 66812, ST. LOUIS, MO 63166-6812. 61XU Class I Land O Lakes Purina LLC is recalling two batches of Pheasants Starter A Medicated feed produced on 6/13/12 and 7/2/12 because there was a formulation error and Vitamin D was omitted. Recall expanded 7-26-12 to include other products due to the lack of added vitamin D. Land O Lakes Purina LLC
Veterinary EXPANDED RECALL: PURINA LATHROP BROILER FINISHER, 783Z, 3000846-201, BULK NET WEIGHT, PURINA MILLS, LLC, PO BOX 66812, ST. LOUIS, MO 63166-6812 783Z Class I Land O Lakes Purina LLC is recalling two batches of Pheasants Starter A Medicated feed produced on 6/13/12 and 7/2/12 because there was a formulation error and Vitamin D was omitted. Recall expanded 7-26-12 to include other products due to the lack of added vitamin D. Land O Lakes Purina LLC
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W036811167601(Part A); W036811167601(Part B) Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Red Blood Cells W036810147118; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Platelets Pooled Leukocytes Reduced W036810810933; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Blood and Blood Products for Reprocessing W036810147118; Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Cryoprecipitated AHF W036810147118; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Red Blood Cells W036811144281; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Platelets Pooled Leukocytes Reduced W036811807521; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Fresh Frozen Plasma W036811144281; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Red Blood Cells Leukocytes Reduced W053512009319; W053512000355; W053512002729; W053511145005; Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Central Jersey Blood Center, Inc.
Biologics Red Blood Cells W036811002671; Class II Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed. Community Blood Centers of Florida, Inc.
Biologics Cryoprecipitated AHF, Pooled W037711502217; Class II Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed. Hoxworth Blood Center UC Medical Center
Biologics Plasma Frozen 03KH50314; Class III Blood product, collected from a donor in whom donor suitability was not adequately determined, was distributed. The American National Red Cross - Southern Region
Biologics Platelets Pheresis Leukocytes Reduced W069112124734(Part A); W069112124734(Part B) Class II Blood product, which did not meet the acceptable product specifications, were distributed. Mississippi Blood Services Inc.
Devices Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge This is an in vitro diagnostic test for the quantitative measurement of total homocysteine (HCYS) in human serum, heparinized plasma, and EDTA plasma on the Dimension Vista(R) System. Measurements of homocysteine aid in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. Lot numbers 12062MA, exp 12/01/2012; and 12066MA, exp 12/05/2012 Class III Cartridges are leaking. The leaking is observed when opening the wrapper that holds the reagent cartridge. Siemens Healthcare Diagnostics, Inc.
Biologics Platelets Pheresis Leukocytes Reduced W1151121920405; Class II Blood product, which did not meet acceptable product specifications, was distributed. LifeSouth Community Blood Centers Inc - Birmingham Region
Biologics Platelets Pheresis Leukocytes Reduced W115112242560G; Class II Blood product, which did not meet the acceptable product specifications, was distributed. LifeSouth Community Blood Centers, Inc.
Biologics Platelets Pheresis Leukocytes Reduced W1151121581200; Class II Blood product, which did not meet acceptable product specifications, was distributed. LifeSouth Community Blood Centers Inc - Birmingham Region
Biologics Red Blood Cells W038509323445; Class II Blood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed Walter L. Shepeard Community Blood Center, Inc.
Biologics Cryoprecipitated AHF W038509323445; Class II Blood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed Walter L. Shepeard Community Blood Center, Inc.
Biologics Red Blood Cells W036811000752; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Blood and Blood Products for Reprocessing W036811000752; Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Platelets Pooled Leukocytes Reduced W036809807127; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Cryoprecipitated AHF W036809230283; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Blood and Blood Products for Reprocessing W036809230283; Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells (Apheresis) W038112098387; Class II Blood product, labeled 'leukoreduced', but which had not undergone leukoreduction, was distributed. Florida's Blood Centers, Inc.
Biologics Red Blood Cells 2621030; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Platelets Pooled Leukocytes Reduced Irradiated 2926630; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Fresh Frozen Plasma 2621030; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Red Blood Cells Leukocytes Reduced W333612044123; W333612010664; W333611093208; Class II Blood products, which were collected from a donor who traveled to malarial endemic areas, were distributed. Mississippi Valley Reg Bld Ctr
Biologics Red Blood Cells Leukocytes Reduced W041010152697I; Class II Blood product, positive for the S-antigen but labeled as S-antigen negative, was distributed. Blood Systems Inc
Biologics Platelets Pheresis Leukocytes Reduced W038612824624; W038612824624; W038612824624; Class II Blood products, which did not meet acceptable product specifications, were distributed. Suncoast Communities Blood Bank, Inc.
Biologics Red Blood Cells Leukocytes Reduced W333612081852; Class III Blood product, manufactured with an undetermined quantity of additive solution, was distributed. Mississippi Valley Reg Bld Ctr
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W051512070531 Class II Blood products, with a low pH, was distributed. Memorial Blood Centers
Biologics Blood and Blood Products for Reprocessing W051512022383; Class II Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed. Memorial Blood Centers
Biologics Red Blood Cells W051512022383; Class II Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed. Memorial Blood Centers
Biologics Platelets Pheresis Leukocytes Reduced W051511105499; Class II Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed. Memorial Blood Centers
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W051511105499; Class II Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed. Memorial Blood Centers
Biologics Source Plasma 12MKEB0609; 12MKEB0320; 12MKEA9877; 12MKEA9596; 12MKEA9031; 12MKEA8768; 12MKEA8361; 12MKEA8054; 12MKEA7641; 12MKEA7343; 12MKEA5778; 12MKEA5299; 12MKEA5112; 12MKEA4574; 12MKEA3828; 12MKEA3383; 12MKEA3237; 12MKEA2878; 12MKEA2739; 12MKEA2429; 12MKEA2241; 12MKEA1812; 12MKEA1638; 12MKEA1270; YP028051; 12MKEA0759; 12MKEA0530; 12MKEA0047; 11MKED9274; 11MKED8647; 11MKED8357; 11MKED7556; 11MKED7270; Class II Blood products, collected from a donor who was permanently deferred, were distributed. Interstate Blood Bank, Inc. of Wisconsin
Biologics Source Plasma 12MKEA6076; 12MKEA5884; Class II Blood products, collected from a donor who was permanently deferred, were distributed. Interstate Blood Bank, Inc. of Wisconsin
Biologics Red Blood Cells Leukocytes Reduced W035212163746N; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Carter BloodCare
Biologics Blood and Blood Products for Reprocessing W035212163746N; Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Carter BloodCare
Biologics Red Blood Cells Leukocytes Reduced W043212055994; Class III Blood product, collected using expired cryo blood collection bag was distributed. Blood Assurance Inc
Devices "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2740***" Ophthalmic surgery MAFD350, M381400, M407870, M439070, M439090, M466140, M495140, M495190, M510800, M554700, M554740, M585650, M656720, M656730, MABL380, MABQ000, MADM740 Class II Potential for bent tips. Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.
Devices "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2840***" Ophthalmic surgery M342500, M342510, M415840, M439130, M446040, M495130, M495160, M510810, M553460, M553470, M553480, M585640, M585740, M652760, M652770, M652780, MADP160, MADP170 Class II Potential for bent tips. Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.
Devices "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3040***" Ophthalmic surgery MABQ150, MAGS310, MAJC690 Class II Potential for bent tips. Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.
Devices "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3240***" Ophthalmic surgery MAKR840, MALZ570, MALZ580, MAMQ990, MAMR000, MANP250, MAPR320, MAQD910 Class II Potential for bent tips. Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.
Biologics Blood and Blood Products for Reprocessing W036510091494; Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed. LifeShare Blood Centers
Biologics Red Blood Cells (Apheresis) W086212003130; W086212003124; Class III Blood products, leukoreduced greater than five days after collection, were distributed. ITXM Clinical Services
Biologics Fresh Frozen Plasma W036808102669; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Blood and Blood Products for Reprocessing W036808102669; Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells Leukocytes Reduced W036812405799; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Platelets Pooled Leukocytes Reduced W036812834939; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Fresh Frozen Plasma W036812405799; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells W036811173182; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Fresh Frozen Plasma W036811173182; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Platelets Pooled Leukocytes Reduced W036811811523; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Red Blood Cells 2737405; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Cryoprecipitated AHF 2737405; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Blood and Blood Products for Reprocessing 2737405; Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Food Mango Medley, 16 oz (contains cantaloupe, honeydew, mango, grapes), distributed by Fresh Food Mfg, 2500 Love Road, Freedom, PA 15042, UPC 3003430338 (4 -16 oz clear plastic containers per case) UPC 3003430338, all product with expiration dates of 8/11/2012 through 8/31/2012 Class I Recalling firm was notified the Mangoes used in production of product were recalled by supplier (Splendid Foods) for possible Salmonella contamination. Giant Eagle
Devices AC Powered adjustable hospital bed, Prime Bed TL500, Distributed by: Primus Medical LLC, 8401 Southern Blvd, Boardman, OH 44512. Usage: Hospital Bed. Model #TL500; Serial Number: 001, 002, 003, 004, 005, 006, 007, 010, 013, 014, 015, 016, 017, 018, 021, 022, 023, 024, 025, 026, 027, 028, 029, 030, 031, 032, 033, 034, 035, 039, 040, 041, 042, 043, 044, 045, 046, 047, 048, 049, 050, 052, 053, 054, 055, 056,  ...
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Class II The "Retaining washers & Clevis Pins" provided with the AC -powered adjustable hospital beds may fail under certain circumstances. The pins at the top of the leg were disengaging from the channel. This may cause the bed frame to come off tracks or collapse. Primus Medical LLC
Devices Boule Con Diff US Tri Pack, 6 Vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. Product part 501-605, Lot #1005-549 Class III Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled the Boule Con Diff US Tri Pack (Product part 501-605, Lot #1005-549 and Product part 501-607, Lot #1005-549) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was imitated due to receipt of customers stating the MCV values and RDW% recovered for Boule Con-Diff Tri pack Lot 1005-549 were low and out of the assay range. Clinical Diagnostic Solutions
Devices Boule Con-Diff Hematology Control 9 vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. Product part 501-607, Lot #1005-549 Class III Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled the Boule Con Diff US Tri Pack (Product part 501-605, Lot #1005-549 and Product part 501-607, Lot #1005-549) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was imitated due to receipt of customers stating the MCV values and RDW% recovered for Boule Con-Diff Tri pack Lot 1005-549 were low and out of the assay range. Clinical Diagnostic Solutions
Devices Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. Product Part 501-605, Lot #1102-575 and Lot # 1102-576 Class III Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (Product Part 501-605, Lot #1102-575 and 1102-576; Product Part 501-607, Lot #1102-576; and Product Part 502-012, Lot #1102-574) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was initiated due to the receipt of a complaint stating the MCHC parameter of the Low Control of Boule Con-Diff US Tri Pack lot number 1102-575 recovered low and out of range. Clinical Diagnostic Solutions
Devices Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. Product Part 501-607, Lot #1102-576 Class III Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (Product Part 501-605, Lot #1102-575 and 1102-576; Product Part 501-607, Lot #1102-576; and Product Part 502-012, Lot #1102-574) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was initiated due to the receipt of a complaint stating the MCHC parameter of the Low Control of Boule Con-Diff US Tri Pack lot number 1102-575 recovered low and out of range. Clinical Diagnostic Solutions
Devices Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. Product Part 502-012, Lot #1102-574 Class III Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (Product Part 501-605, Lot #1102-575 and 1102-576; Product Part 501-607, Lot #1102-576; and Product Part 502-012, Lot #1102-574) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was initiated due to the receipt of a complaint stating the MCHC parameter of the Low Control of Boule Con-Diff US Tri Pack lot number 1102-575 recovered low and out of range. Clinical Diagnostic Solutions
Devices Alloclassic SL Shaft Item 2839, 2840, 2841, 2842, 2843, 2844, 2845, 2846, 2847, 2848, 2949, 2851, 2852, 2883, 2884, 2885, 2886, and 2887 Lots: 2359249, 2359251, 2359251, 2368739, 2413914, 2413914, 2426010, 2526138, 2335608, 2381324, 2387449, 2388541, 2401237, 2401237, 2492774, 2523553, 2355767, 2355767, 2361511, 2361511, 2371517, 2376476, 2440672, 2453100, 2479736, 2498363, 2529208, 2303302, 2347856,  ...
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Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 2010 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Biolox® delta Ceramic Femoral Head Rx only, sterile REF Numbers: 00-8775-028-01, 00-8775-028-02, 00-8775-028-03, 00-8775-032-01, 00-8775-032-02, 00-8775-032-03, 00-8775-032-04, 00-8775-036-01, 00-8775-036-02, 00-8775-036-03, 00-8775-036-04, 00-8775-040-01, 00-8775-040-02, 00-8775-040-03, and 00-8775-040-04. Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Biolox® Option Ceramic Femoral Head System Rx, sterile REF Numbers: 00-8777-028-02, 00-8777-036-01, 00-8777-036-02, and 00-8777-040-01. Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Wagner SL Revision Stem, uncemented Sterile REF Numbers: 01.00101.914, 01.00101.915, 01.00101.916, 01.00101.917, 01.00101.918, 01.00102.217, 01.00102.219, 01.00102.221, 01.00102.619, 01.00102.620, 01.00102.621, 01.00102.622, 01.00103.015, 01.00103.017, 01.00103.021, 01.00103.025, 30.00.89.160, and 30.00.89.190. Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Alloclassic® SL-Offset Stem sterile, Rx REF Numbers: 01.00121.020, 01.00121.030, 01.00121.040, 01.00121.050, 01.00121.060, 01.00121.070, and 01.00121.090. Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Metasul® LDH® Head Rx Sterile REF Numbers: 01.00181.380, 01.00181.400, 01.00181.420, 01.00181.440, 01.00181.460, 01.00181.480, 01.00181.500, 01.00181.520, 01.00181.540, 01.00181.560, 01.00181.580, 01.00181.600, Lots:2336407, 2384226, 2417501, 2379463, 2414200, 2435636, 2437758, 2437758, 2439049, 2318066, 2318066, 2318066, 2337823, 2341591, 2341591, 2350267, 2350642, 2356116, 2379464, 2393154, 2393154, 2407029, 2417505, 2417505, 2334410, 2337816, 2337817, 2342259, 2350644, 2356119, 2356129, 2357620, 2357620, 2367367, 2414126, 2417566,  ...
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Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Metasul® Durom® Femoral component Sterile, Rx REF Numbers: 01.00211.140, 01.00211.144, 01.00211.152, 01.00211.154. 01.00211.156, 01.00211.158, and 01.00211.160. Lot: 2367454, 2367454, 2367454, 2367454, 2367455, 2367455, 2374382, 2374382, 2374382, 2374382, 2381632, 2381632, 2381634, 2381634, 2409055, 2414048, 2397713, 2397713, 2417888, 2380622, 2380622, 2388389, 2388389, 2388389, 2453506, 2422704, 2375235, 2375235, 2375235, 2394700, and 2508571 Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices MS-30® Stem REF Numbers: 01.00351.005, 01.00351.006, lots 2330077, 2397912 Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices MS-30® Distal centralizer, cemented, sterile, Rx REF Numbers: 01.00351.005, 01.00351.006, 01.00351.014, 01.00351.214, 01.00351.216, 01.00351.416, 01.00351.620, 01.00356.008, 01.00356.010.Lot 2330077, 2397912, 2319413, 2280640, 2386348, 2399448, 2389980, 2389980, 2389980, 2389980, 2426020, and 2430035. Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices MS-30® Proximal positioner REF Number: 01.00351.265, lot 237973 Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Fitmore" Hip Stem REF Numbers: 01.00551.102, 01.00551.103, 01.00551.104, 01.00551.106, 01.00551.108, 01.00551.109, 01.00551.110, 01.00551.111, 01.00551.112, 01.00551.201, 01.00551.202, 01.00551.203, 01.00551.204, 01.00551.205, 01.00551.206, 01.00551.207, 01.00551.208, 01.00551.209, 01.00551.210, 01.00551.211, 01.00551.301, 01.00551.302, 01.00551.303, 01.00551.307, 01.00551.308, 01.00551.309, 01.00551.312, 01.00551.313, 00551.402, 00551.405, 00551.407, 00551.408, 00551.409, and 00551.411. Lot: 2492112, 2405383, 2461916, 2486221, 2486734, 2414003, 2379860, 2384352, 2382041, 2406708, 2486291, 2458770, 2479902,  ...
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Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Wagner cone Prosthesis, uncemented, sterile, Rx REF Numbers: 01.00561.214, 01.00561.215, 01.00561.222, 01.00561.313, 01.00561.314, 01.00561.316, 01.00561.317, 01.00561.318, 01.00561.319, and 01.00561.321 Lot:2323157, 2411401, 2505266, 2352457, 2352457, 2323311, 2381296, 2446509, 2336139, 2451855, 2397244, 2451874, 2459988, 2517770, 2528611, 2455390, 2336084, 2413210 Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices CoCr Head, sterile, Rx REF Numbers: 01.01012.384, 01.01012.385, 01.01012.386, 01.01012.387, and 01.01012.388 Lot2369409, 2435773, 2448280, 2480485, 2480485, 2397348, , 2402739, 2412633, , 2420719, 2481695, 2520521, 2333576, 2354292, 2369416, 2398778, 2412631, 2447614, 2462604, 2484118, 2498778, 2501857, 2524940, 2524941, 2527698, 2531506, 2531507, 2330195, 2341655, 2448278, 2482086, 2512070, 2518101, 2490816, and 2498784 Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Anatomical Shoulder" Humeral stem REF Numbers: 01.04201.072, 01.04201.092, 01.04201.102, 01.04201.122, 01.04201.142, 01.04211.072, 01.04211.092, 01.04211.122, and 01.04211.142 Lot 2333904, 2403849, 2416919, 2443150, 2327341, 2452413, 2320506, 2323574, 2364979, 2373235, 2406171, 2416913, 2438286, 2485091, 2331445, 2357957, 2436420, 2440113, 2470299, 2492996, 2320516, 2334543, 2387483, 2411827, 2421859, 2441600, 2511328, . Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Anatomical Shoulder" Fracture Humeral stem REF Numbers: 01.04207.072, 01.04207.082, 01.04207.092, 01.04207.112, 01.04207.132, 01.04207.142, 01.04217.072, and 01.04217.132. Lot 2360479, 2373842, 2331163, 2401526, 2458833, 2360473, 2451660, 2387138, 2521377, 2342166, 2455419, 2342646, 2436406, 2362563, 2413744, 2423092, 2423094, 2472576, 2433869, Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Anatomical Shoulder" Humeral Head REF Numbers: 01.04212.400, 01.04212.420, 01.04212.440, 01.04212.460, 01.04212.480, 01.04212.500, 01.04213.480, and 01.04213.520. LotsLots: 2335921, 2388114, 2475819, 2475819, , 2444895, 2485536, 2397602, 2437195, 2485540, 2397014, 2408970, 2483098, 2370444, 2437201, 2458785, 2458785, 2323268, 2434637, 2334433, 2473843, 2530732, 2336444 Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices zimmer Anatomical Shoulder Glenoid S, cemented, sterile; REF 01.04214.340 PE Keeled Glenoid S, cemented, sterile; REF 01.04214.345, Glenoid M, cemented, sterile; REF 01.04214.370, Glenoid L, cemented, sterile; REF 01.04214.400 PE Keeled Glenoid L, cemented, sterile; REF 01.04214.405 REF Numbers: 01.04214.340, 01.04214.345, 01.04214.370, 01.04214.400, and 01.04214.405. Lot 2416527, 2430357, 2447460, 2450204, 2348311, 2348311, 2364768, 2364768, 2364768, 2403597, 2418592, 2418592, 2452946, 2453947, 2503319, 2503319, 2517200, 2329832, 2349655, 2388161, 2453280, 2453280, and 2533474. Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Anatomical Shoulder" Revision Humeral stem,7,9,12,14 and Anatomical Shoulder Fracture Humeral stem REF Numbers: 01.04215.072, 01.04215.092, 01.04215.122, 01.04215.142. , 01.04217.072, 01.04217.132 Lot 2398402, 2485014, 2347028, 2347028, 2380422, 2348099, 2341901, 2435527, 2398475 Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Zimmer Inverse/Reverse Screw system, REF Numbers: . 01.04223.018, 01.04223.024, 027, 030, 033, 036, 042 Lot 2398030, 2430525, 2384923, 2390913, 2396961, 2399397, 2416652, 2424581, 2430509, 2449770, 2497224, 2383780, 2430522, 2430523, 2430523, 2477654, 2484611, 2383751, 2396967, 2399398, 2416653, 2416653, 2422337, 2429084, 2447019, 2463617, 2521820, 2349258, 2383781, 2388857, 2420337, 2428101, 2447022, 2521822, 2383794, 2385133, 2387452, 2390941 , Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Anatomical Shoulder" Inverse Humeral Cup REF Numbers: 01.04223.100, 01.04223.106, 01.04223.111, 01.04223.121, 01.04223.190, and 01.04223.196.Lot 2310656, 2429295, 2468509, 2310648, 2410046, 2486362, 2474203, 2317777 Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Anatomical Shoulder" Inverse/Reverse Glenoid Sterile, Rx REF Numbers: 01.04223.200 and 01.04223.236 2313338, 2314443, 2318819, 2331464, 2342906, 2343151, 2346399, 2368714, 2387755, 2425692, 2468583, 2468587, 2471765, 2503386, 2516402 Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Anatomical Shoulder" Inverse/Reverse Humeral PE-Insert Sterile, Rx REF Numbers: 01.04223.360, 01.04223.366, 01.04223.400, 01.04223.403, and 01.04223.406 Lot:2330423, 2337486, 2503675, 2335914, 2324383, 2395586, 2405596, 2465511, 2309008, 2309008, 2309008, 2446964, Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Anatomical Shoulder" Ball taper for humeral stem REF Numbers: 01.04227.102, Lot:2350372, 2381792, 2398201, 2452078, 2460783 Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Anatomical Shoulder" Fracture Humeral Head REF Numbers: 01.04227.400, 01.04227.405, 01.04227.480, and 01.04227.485 Lot 2352153, 2358721, 2366101, 2525804, 2494527, 2523912, 2385885, 2441471 Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices CLS Stem REF Numbers: 29.00.09.137, 29.00.09.162, 29.00.39.070, and 29.00.39.125 Lot 2397894, 2393484, 2480480, 2439729, Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Original M.E. Mueller" Low Profile Cup Sterile, Rx REF Numbers: 63.32.46, 63.32.60 and 63.32.62.Lot 2378026, 2468907, 2370934 Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Dynesys® Set screw M6 REF Numbers: 01.03710.006 and 01.03711.006 Lot 2381797, 2429082 Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Dynesys® Universal spacer 6-45 REF Number: 01.03710.645, Lot 2323776, 2340853, 2347195, 2347196, 2349405, 2352968, 2361598, 2363757, 2368549, 2371803, 2374584, 2374695, 2390243, 2390244, 2392322, 2394946, 2395677, 2410170, 2410171, 2413068, 2414198, 2417869, 2419315, 2419317, 2424170, 2430156, 2439598, 2449297, 2452033, 2454477, 2455648, 2455649, 2469131, 2469132, Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Dynesys® L.I.S. Stabilizing cord Rx, Sterile REF Numbers: 01.03711.100 and 01.03711.200 Lot2290106, 2322753, 2322757, 2325303, 2328500, 2350135, 2363929, 2363972, 2366663, 2377045, 2391793, 2409738, 2422397, 2444114, 2448948, 2453742 Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Dynesys® Revision + set screw REF Numbers: 01.03716.035, 01.03716.040, 01.03716.045, 01.03716.050, 01.03716.435, 01.03716.440, 01.03716.445, 01.03716.450, 01.03716.455 and 01.03717.250 Lot: 2368864, 2344115, 2367073, 2396142, 2334238, 2444021, 2377110, 2305486, 2377111, 2323497, 2389720, 2403550, 2433036, 2444022, 2298967, 2305536, 2348795, 2358159, 2368866, 2368867, 2389721, 2394352, 2449099, 2368870, 2441343, 2367060, 2367062, 2373095, 2373097 Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Dynesys® HA Pedicle + set screw REF Numbers: 01.03756.040, 01.03756.050, 01.03756.440, 01.03756.445, 01.03756.450, 01.03756.455, 01.03757.235, 01.03757.240, 01.03757.245, 01.03757.250, 01.03757.255, 01.03758.040, 01.03758.050 and 01.03758.055 Lot: 2399360, 2502246, 2519160, 2323382, 2399361, 2459377, 2500751, 2383797, 2425044, 2449147, 2373116, 2411907, 2323399, 2344133, 2344133, 2426558, 2359295, 2426560, 2456268, 2502250, 2323446, 2488882, 2444047, 2323449, 2433071, 2323450, . Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthru, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices DTO" Implant REF Numbers: 01.03791.050, 01.03791.060, and 01.03791.080 Lot: 2417930, 2417948, 2417950, 2417956, 2429074, 2432771, 2462074, 2512965, Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Dynesys® Top-Loading System Cannulated Pedicle + Set Screw REF Numbers: 01.03915.245, 01.03916.055, 01.03916.435, 01.03916.440, 01.03916.445, 01.03916.450, 01.03916.455, 01.03917.235, 01.03917.245, 01.03917.250, 01.03917.255, 01.03918.040, 01.03918.045, 01.03918.055, 01.03955.235, 01.03955.245, 01.03955.255, 01.03956.035, 01.03956.435, 01.03956.440, 01.03956.450, 01.03957.240, 01.03957.250, 01.03957.255, 01.03958.045 and 01.03958.050. Lot:2443724, 2443727, 2443738, 2443740, 2443750, 2443751, 2443770, 2449369, 2449373, 2449374, 2449375, 2449416, 2459041, 2459046, 2459051, 2459087, 2459106, 2471700, 2475668, 2475670, 2475672,  ...
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Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices NCB® cancellous screw REF Number: 02.02152. 085 Lot 2477869 Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices NCB® screw Ø 4.0 self-tapping REF Numbers: 02.02155.026 and 02.02155.030 Lots2450611, 2475382 Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices NCB®-PT lateral proximal 3 hole tibial plate REF Numbers: 02.02261.305, 02.02261.307, 02.02261.309, and 02.02261.313. Lot:2442904, 2341498, , 2402100, 2407066, 2414036, 2422428, 2426611, 2434987, 2442908, 2387467, 2387467, 2402996, 2407064, 2422433, 2450659, 2450659, 2450644, Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices NCB®-PH Plate REF Numbers: 02.02262.105 and 02.02262.107. Lot 2450659, 2450644 Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Sirus® intramedullary nail for tibia, cannulated Ø REF Numbers: 02.02631.030, 02.02631.031, 02.02631.033, 02.02631.034, 02.02631.036, 02.02631.038, 02.02631.130, 02.02631.131, 02.02631.133, 02.02631.134, 02.02631.142, 02.02631.233, 02.02631.925, 02.02631.928, 02.02631.930, 02.02631.931, 02.02631.933, 02.02631.934, 02.02631.936, and 02.02631.940. Lot: 2394172, 2400103, 2400105, 2403109, 2403116, 2403125, 2403127, 2403136, 2403138, 2406268, 2406270, 2406272, 2406276, 2406278, 2406280, 2408059, 2408125, 2408131, 2408135, 2409963, 2409973, 2412348, 2414763, 2414765, 2414767, 2414773, 2414775,  ...
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Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Kopf Adapter S Sterile, Rx REF Numbers: 01.00185.145, 146, 147, 148 2329720, 2345868, 2351558, 2351558, 2357964, 2357985, 2363710, 2365318, 2390727, 2401986, 2404475, 2420196, 2424824, 2424824, 2428509, 2449961, 2469199, 2476706, 2476706, 2476708, 2476708, 2486173, 2324764, 2335268, 2339607, 2342207, 2342207, 2342209, 2342211, 2354632, 2357988, 2365331, 2368841, 2385720, 2388044, 2396086, 2399440, 2404481, 2408183, 2414476, 2414480, 2420203, 2420203, 2424841, 2428528,  ...
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Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices MS-30 Shaft, Sterile, Rx 30.00.49-100, 140, 160; Lots 2396807, 2390863, 2321477 Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Food "Tacos de Jueyes" (Crab Tacos) - Food Service none Class II Undeclared allergens: wheat, soy, crustacean shellfish (crab), and yellow #5 Fabrica Confecciones Soto, Inc.
Food "Alcapurria Jueyes" (Crab-filled fritters) - Food Service none Class II Undeclared allergens: wheat, soy, crustacean shellfish (crab), and yellow #5 Fabrica Confecciones Soto, Inc.
Devices STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasma, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy. K082248 D089976 Ref 58104 units Class II Following a single customer complaint that incorrect INR values were occasionally printed for PT tests, even though the primary units (seconds) were correct, the firm investigated and confirmed the potential for printing incorrect secondary units when using an external printer and the customer printout mode on the STA Satellite®. Diagnostica Stago, Inc.
Devices Hoffman LRF Telescopic Strut Short Stryker Stryker Trauma AG CH-2545 Seizach Distributed in the USA by Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The use of external devices provides the surgeon with a means of bone fixation for the management of fracture and reconstructive surgery. These devices are intended only to assist healing and are not intended to replace normal bone structures. External fixation devices are intended to hold fractured bone surfaces in apposition to facilitate normal healing. While proven successful, the devices are manufactured from metal, plastic, and composite materials. No such fracture fixation device, subject to fatigue, can be expected to withstand activity levels in the same way as would a normal health bone. The external fixation system, therefore, will not be as strong, reliable or durable as a normal human bone. K113327 Catalog No: Telescopic Strut Extra Short Hoffman LRF Length: 4933-0-100 :100-125mm (Black) 4933-0-120 Telescopic Strut Short Hoffman LRF Length: 119-161 mm (Yellow) 4933-0-140 Telescopic Strut Medium Hoffman LRF Length 138-201 mm (Blue) 4933-0-180 Telescopic Strut Long Hoffman LRF Length: 177-277 mm (Red); Lot Code: 4933-0-100 Telescopic Strut Extra Short Hoffman LRF Length 100-125mm (Black) X28937; Z04197; Z09163;  ...
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Class II Three complaints have been filed where the Hoffman LRF Telescopic Struts have broken during load bearing application by patients having a body weight greater than 250 LBS. Stryker Howmedica Osteonics Corp.
Food Fresh Express, Hearts of Romaine, 18 oz, Fresh Express Incorporated, packed in clear flexible plastic package. Product Code: S270A24, UPC 71279-26201, Best Use By Date: Oct 11. Class I Sample of Fresh Express Hearts of Romaine tested positive for Salmonella. Fresh Express Incorporated
Food Fruit Mango Peeled & Halved, Ready-To-Eat Product, 2, 2.5-lb trays per case Item Number 881262 Class I Coast Citrus Distributors, Inc. and its divisions Coast Tropical and Olympic Fruit & Vegetables are conducting a voluntary product recall of Kent's brand & Keitt's brand mangoes packed at Agricola Daniella due to salmonella associated with mangoes from this producer. FreshPoint Central Florida
Food Mixes, Salsa Mango Papaya, Ready-To-Eat Product, 2, 5-lb trays per case Item Number 480124 Class I Coast Citrus Distributors, Inc. and its divisions Coast Tropical and Olympic Fruit & Vegetables are conducting a voluntary product recall of Kent's brand & Keitt's brand mangoes packed at Agricola Daniella due to salmonella associated with mangoes from this producer. FreshPoint Central Florida
Food Fruit Mango Peeled & Diced 1/4, Ready-To-Eat Product, 2, 5-LB Trays per case Item Number 512544 & 812544 Class I Coast Citrus Distributors, Inc. and its divisions Coast Tropical and Olympic Fruit & Vegetables are conducting a voluntary product recall of Kent's brand & Keitt's brand mangoes packed at Agricola Daniella due to salmonella associated with mangoes from this producer. FreshPoint Central Florida
Food Fruit Mango Peeled & Diced 1/2, Ready To Eat Product, 2, 5-LB Trays per case Item Number 480095, 481351, and 880095 Class I Coast Citrus Distributors, Inc. and its divisions Coast Tropical and Olympic Fruit & Vegetables are conducting a voluntary product recall of Kent's brand & Keitt's brand mangoes packed at Agricola Daniella due to salmonella associated with mangoes from this producer. FreshPoint Central Florida
Food Fruit Mango Whole Peeled, Ready-To-Eat Product, 2, 5-LB Trays per case Item Number 481286 Class I Coast Citrus Distributors, Inc. and its divisions Coast Tropical and Olympic Fruit & Vegetables are conducting a voluntary product recall of Kent's brand & Keitt's brand mangoes packed at Agricola Daniella due to salmonella associated with mangoes from this producer. FreshPoint Central Florida
Food Mixes, Salsa Mango Bucket, Ready To Eat Product, 1 Gal; & Salsa Mango packaged in 5-lb Trays with 2 trays per case. Item Number 513400, 880126 & 480126 Class I Coast Citrus Distributors, Inc. and its divisions Coast Tropical and Olympic Fruit & Vegetables are conducting a voluntary product recall of Kent's brand & Keitt's brand mangoes packed at Agricola Daniella due to salmonella associated with mangoes from this producer. FreshPoint Central Florida
Food Fruit Mango Peeled and Sliced, Ready To Eat Product, 2, 5-lb Trays per case Item Number 482100 & 481274 Class I Coast Citrus Distributors, Inc. and its divisions Coast Tropical and Olympic Fruit & Vegetables are conducting a voluntary product recall of Kent's brand & Keitt's brand mangoes packed at Agricola Daniella due to salmonella associated with mangoes from this producer. FreshPoint Central Florida
Food Mixes Salsa/Mango Pineapple, Ready To Eat Product, 2, 5-lb Trays per case Item Number 481870 Class I Coast Citrus Distributors, Inc. and its divisions Coast Tropical and Olympic Fruit & Vegetables are conducting a voluntary product recall of Kent's brand & Keitt's brand mangoes packed at Agricola Daniella due to salmonella associated with mangoes from this producer. FreshPoint Central Florida
Devices The brand name of the device is AlgiNot, a dental impression material. Product Part Numbers AlgiNot Intra Kit 34683 AlgiNot Volume Refills 34682 Lot Number 1-1017 AlgiNot is a Class II Medical Device. The device listing number this product is 0136496 and the establishment registration number for Kerr Corporation is 1815757. Intended as an alternative to traditional alginate materials. ÿProduct Part Numbers Lot Number AlgiNot Intra Kit 34683 1-1017 AlgiNot Volume Refills 34682 1-1017 Class II The firm recalled the product because it may cure harder than expected within the shelf life, which could result in a material that may be more difficult to remove. Use of this product on patients with loose teeth may result in possible tooth fracture or tooth extraction. Kerr Corporation
Devices Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1 (List Number 06F12-09; Lot Number 071039) Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 2 (List Number 06F12-10; Lot Number 081039) Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 3 (List Number 06F12-11; Lot Number 091039) Usage: Assayed human plasma which may be used to verify the integrity of newly received i-STAT CK-MB cartridges. Cliniqa Liquid QC Cardiac Marker Control for i-STAT Level 1 (List #06F12-09; Lot Number 071039) Cliniqa Liquid QC Cardiac Marker Control for i-STAT Level 2 (List #06F12-10; Lot Number 081039) Cliniqa Liquid QC Cardiac Marker Control for i-STAT Level 3 (List #06F12-11; Lot Number 091039) Class III Abbott Point of Care (APOC) has determined that for the Cliniqa Liquid QC Cardiac Marker Control for i-STAT Level 1 (List #06F12-09; Lot Number 071039); i-STAT Level 2 (List #06F12-10; Lot Number 081039); and i-STAT Level 3 (List #06F12-11; Lot Number 091039) results may be generated below the lower value assignment range for some vials. Abbott Point Of Care Inc.
Food Kellogg's Frosted Mini Wheats , Bite Size, Lightly Sweetened Whole Grain Wheat Cereal, 96 ct case single serve,each Nt. Wt. 1 oz (28g); 18 oz carton; 24 oz carton; 30 oz., 70 ct case single serve, 70 oz carton Canadian product: Kellogg's Mini-Wheats Original Frosted Cereal 440 G, 510 G,850 G, 1300 G, 1600 G carton USA ONLY products with the letters KB, AP, preceding or following the Better If Used Before Date Apr 01 2013 - Sep 21 2013. Frosted Case UPC: 3800004996, 3800031828, 3800031833, 3800059646, 3800073443, 3800077602, 3800021992, 3800051692 Package Frosted UPC: 3800004996, 3800031829, 3800031834, 3800031829, 3800073444, 3800046954, 3800021992, 3800031921 Canadian Case Codes: 6410020534, 6410052655, 6410056918,  ...
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Class II This voluntary recall is initiated due to the possible presence of fragments of flexible metal mesh from a faulty manufacturing part that were found in certain Mini-Wheats® cereal produced in a single Kellogg plant between April 1 and September 21, 2012. Kellogg Company
Food Kellogg's Mini Wheats, Unfrosted, Bite Size, Lightly Sweetened Whole Grain Wheat Cereal, 18 oz carton; 70 ct case single serve; Canadian: Kellogg's Mini-Wheats Original cereal 12 ct, 850 G USA ONLY products with the letters KB, FK, preceding or following the Better If Used Before Date Apr 01 2013 - Sep 21 2013. FrostedCase UPC:3800004996, 3800031828, 3800031833, 3800021992, 3800005337, 3800070418, 3800022055, , 3800038118, , 3800007337, 3800007338. Unfrosted Case UPC 3800058689, 3800021982. Package Frosted UPC: 3800004996, 3800031829, 3800031834, 3800021992, 3800005332,  ...
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Class II This voluntary recall is initiated due to the possible presence of fragments of flexible metal mesh from a faulty manufacturing part that were found in certain Mini-Wheats® cereal produced in a single Kellogg plant between April 1 and September 21, 2012. Kellogg Company
Food Kellogg's Variety and Assortment Packs containing Frosted/ Unfrosted Mini Wheats, Bite Size, Lightly Sweetened Whole Grain Wheat Cereal, 10 ct; 30 ct, 72 ct , 96 ct. USA ONLY products with the letters FK, HG preceding or following the Better If Used Before Date Apr 01 2013 - Sep 21 2013. Case UPC: 3800005337, 3800070418, 3800022055, 3800038118, 3800007337, 3800007338. Carton UPC3800005332, 3800070973, 3800022056, 3800038118, 3800007337, 3800007338 Class II This voluntary recall is initiated due to the possible presence of fragments of flexible metal mesh from a faulty manufacturing part that were found in certain Mini-Wheats® cereal produced in a single Kellogg plant between April 1 and September 21, 2012. Kellogg Company
Food Canadian Product: Kellogg's Mini Wheats, Brown Sugar Flavour Cereal, 6 ct., 10 ct, 12 ct, 16ct; 400G, 510G, 850 G, 1300 G Date code 2013 AL 01-2013 Jl 29 Case UPC6410020738, 6410044892, 6410052652, 6410059008, 6410059011 Class II This voluntary recall is initiated due to the possible presence of fragments of flexible metal mesh from a faulty manufacturing part that were found in certain Mini-Wheats® cereal produced in a single Kellogg plant between April 1 and September 21, 2012. Kellogg Company
Food Jamba Juice brand Peanut Butter Moo'd Smoothie; All sizes (small, medium, large); A Blend Of: Nonfat Vanilla Yogurt (Contains Milk), Chocolate Moo'd Base (Contains Milk), Soymilk (Contains Soy), Ice, Bananas, Peanut Butter (Contains Peanuts); The product is processed and packaged by Jamba Juice Co. No codes (Stop sale date: September 24, 2012) Class I The products were manufactured using peanut butter recalled by Sunland Inc. because it may be contaminated with Salmonella. Jamba Juice
Food Jamba Juice brand Chunky Strawberry Topper; All sizes (small, medium, large); A Blend Of: Strawberries, Bananas, Nonfat Plain Yogurt (Contains Milk), Soymilk (Contains Soy), Organic Pumpkin Flax Seed Granola (Contains Soy & Wheat), Peanut Butter (Contains Peanuts); Product is processed and packaged by Jamba Juice Co. No codes (Stop sale date: September 24, 2012) Class I The products were manufactured using peanut butter recalled by Sunland Inc. because it may be contaminated with Salmonella. Jamba Juice
Devices ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35). The ABL80 FLEX CO-OX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL80 FLEX CO-OX system is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point of care setting Serial Numbers: all ABL80 FLEX CO-OX analyzers with sofware versions 1.30, 1.31, 1.32, 1.33, and 1.34. Class II The recall was initiated because SenDx Medical Inc. became aware of a software issue in the ABL80 FLEX CO-OX analyzer related to the reporting of the hemoglobin fractional parameters. Sendx Medical Inc
Devices Sunquest Laboratory, version 7.0 not available not available Class II Sunquest is recalling Sunquest Laboratory version 7.0 because when saving an Accession to a non-current Episode/Event, a User-Defined field can be incorrectly replaced by the current Episode/Event User-Defined data. Sunquest Information Systems, Inc.
Devices Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later. v3.0.0_07222004 and later Class II The recall was initiated because Sunquest Information System has confirmed reports of an Outbound Phlebotomy Point of Care (POC) interface is combining patient orders inappropriately. Sunquest Information Systems, Inc.
Devices S5 Single Roller Pump 150, Item Number: 10-80-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less. Serial Numbers: 10E06219,10E06220, 10E06231-10E06234, 10E06239-10E06241, 10E06255-10E06273, 10E06286-10E06289, 10E06291-10E06355, 10E06359-10E06364, 10E06366, 10E06368-10E06383, 10E06385, 10E06387-10E06391,10E06395-10E06401, 10E06403-10E06447, 10E6502. Class II Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message displayed on the system panel. This could lead to unintended pump stoppage which may result in permanent impairment or life-threatening injury. An out of specification electrical component was determined to be the cause of some of these events. Sorin Group USA, Inc.
Devices S5 Double Roller Pump 85, Item Number: 10-85-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less. Serial Numbers: 10E51854,10E51856-10E51858, 10E51860, 10E51861, 10E51864, 10E51867, 10E51870, 10E51871, 10E51873, 10E51880-10E51897, 10E51899-10E51913. Class II Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message displayed on the system panel. This could lead to unintended pump stoppage which may result in permanent impairment or life-threatening injury. An out of specification electrical component was determined to be the cause of some of these events. Sorin Group USA, Inc.
Devices S5 Mast Roller Pump 85, Item Number: 10-88-60 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less. Serial Numbers: 50E50766--50E50769, 50E50772-50E50774, 50E50783-50E50784. Class II Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message displayed on the system panel. This could lead to unintended pump stoppage which may result in permanent impairment or life-threatening injury. An out of specification electrical component was determined to be the cause of some of these events. Sorin Group USA, Inc.
Devices S5 Mast Roller Pump 150, Item Number: 10-88-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less. Serial Numbers: 50E00680--50E00681, 50E00688, 50E00696-50E00706, 50E00708-50E00718. Class II Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message displayed on the system panel. This could lead to unintended pump stoppage which may result in permanent impairment or life-threatening injury. An out of specification electrical component was determined to be the cause of some of these events. Sorin Group USA, Inc.
Devices Sorin C5 Perfusion System, Item number 58-00-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less. Serial Numbers: 58E00135; 58E00136 Class II Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message displayed on the system panel. This could lead to unintended pump stoppage which may result in permanent impairment or life-threatening injury. An out of specification electrical component was determined to be the cause of some of these events. Sorin Group USA, Inc.
Devices Trochar Scalpel Instrument (Surgical Punch) OrthoPediatrics intramedullary rods (nails) are generally rod-shaped devices, with screw holes at either end for fixation to bone. This device is intended to be inserted into the medullary canal of the femur for fixation of fractures by aligning and stabilizing the bone fragments. Additional stabilization may be realized by installing transverse screws through holes in the rod. These devices are made of medical grade stainless steel. The OrthoPediatrics PediNail" system is used for pediatric and small stature adult patients as indicated to stabilize fractures of the femoral shaft; subtrochanteric fractures; ipsilateral neck/shaft fractures; prophylactic nailing of impending pathologic fractures; nonunions and malunions; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity. Part number: 01-1500-9014 and Lot #'s 1466707 and 1466710 Class II A complaint received from sales representative that a replenishment instrument was too short. Upon investigation, it has been determined that the device was not manufactured to design specifications and will not function as intended. OrthoPediatrics Corp
Food Clemmy's Brand Peanut Butter Chocolate Chip Ice Cream, Pint Size, 16 OZ (437mL), UPC 8 94509 00231 9. Labeling reads in part: "CLEMMY'S RICH AND CREAMY PEANUT BUTTER CHOCOLATE CHIP*** 100% SUGAR FREE LACTOSE FREE GLUTEN FREE, 16 OZ (473mL)***DIST BY: Clemmy's Ice Cream P.O.Box 1746, Rancho Mirage, CA 92270**". 8pints per case. UPC 8 94509 00231 9. Code Date Range 11038-12215. Firm's explanation of Best By date: The first production date of 11038 corresponds to 02/07/2011 and the most recent production date of 12215 corresponds to 08/02/2012. The product carries a 2-year best by print requirement, in the MM/YY format, so expiration date  ...
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Class I Clemmy's Ice Cream of Rancho Mirage, CA is initiating a voluntary recall of Peanut Butter Chocolate Chip 16 ounce containers of ice cream that contains peanut butter associated with the Sunland, Inc., recall. The peanut butter used in this product has the potential to be contaminated with Salmonella. Clemmy's LLC
Food Belfonte Home Run Sundae Ice Cream, A Baseball Nut Blend of Chocolate Peanuts, Chocolate Coated Pretzels, and a Thick Fudge Swirl in Peanut Butter/Chocolate Ice Cream, 56 oz. (1.66L) Belonite Ice Cream Company, Kansas City, MO UPC 83057-91023 Best Used By Date: 04/08/2011; 05/07/2011; 06/03/2011; 06/08/2012; 03/13/2014; 04/26/2014; 06/21/2014; 07/27/2014 Class I Products may contain peanut butter base with potentially contaminated with Salmonella. Belfonte Ice Cream & Dairy Foods Co
Food Belfonte Mama's Choice Premium Ice Cream, Reverse Peanut Butter Pie, Peanut Butter Coated Fudge Filled Cups, Peanut Butter Flakes and Swirled Chocolate Cookie Pie Crust Ribbon in Peanut Butter Ice Cream, 56 oz. (1.66L) Belonite Ice Cream Company, Kansas City, MO UPC 83057-17033 Best Used By Date: 07/15/2011; 10/02/2011; 12/02/2011; 02/09/2012; 04/06/2012; 06/02/2012 Class I Products may contain peanut butter base with potentially contaminated with Salmonella. Belfonte Ice Cream & Dairy Foods Co
Devices Vector TAS Modular Driver, a manual driver for Vector TAS dental screws. Part Numbers 601-0007 and 601-0010, all lots Class II The Instructions For Use (IFUs) for Vector TAS Modular Driver for some foreign language sections incorrectly lists the sterilization temperature as 130°C. The correct sterilization temperature should be listed as 132°C and/or 270°F. Ormco/Sybronendo
Food Chocolate Peanut Butter Non-Dairy Frozen Dessert is sold under brand Luna & Larry's Organic Coconut Bliss. It is packaged in One Pint (473ml) StanPac paperboard container, 8 cups per case. The UPC code 8 96767 00121 9. The product is labeled in parts: "***CHOCOLATE PEANUT BUTTER NON-DAIRY FROZEN DESSERT***Luna & Larry's ORGANIC COCONUT BLISS***1 PINT 473mL***". The product is stamped with 41-61 and a date range of Nov 11 2012 through Oct 24 2013 printed on the bottom of the container Class I Luna & Larry's Coconut Bliss Chocolate Peanut Butter Non-Dairy Frozen Dessert is recalled because it has the potential to be contaminated with Salmonella. The peanut butter used in the product is supplied and recalled by Sunland, Inc. Bliss Unlimited
Devices Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), Inc., Fitchburg, WI. Pinnacle3 Radiation Therapy Planning System is a computer software package intended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes. Pinnacle3 Radiation Therapy Planning System assists the clinician in formulating a treatment plan that maximizes the dose to the treatment volume while minimizing the dose to the surrounding normal tissues. The system is capable of operating in both the forward planning and inverse planning modes. The device is indicated for use in patients deemed to be acceptable candidates for radiation treatment in the judgment of the clinician responsible for patient care. Plans generated using this system are used in the determination of the course of a patient's radiation treatment. They are to be evaluated, modified and implemented by qualified medical personnel. Serial # 317, 318, 319, 320,321,342, 343, 344,345, 346, 347 Class II Philips Medical Systems Cleveland), Inc. is recalling Pinnacle3 Virtual Client Connection software version 3.1 due to an improper release and subsequent distribution. Philips Medical Systems (Cleveland), Inc.
Food Organic NuttZo Omega-3 SEVEN Nut & Seed Butter, Net Wt. 16 oz (1lb) 454 g, UPC 894697002030. Best By Dates 10/7/12-12/31/12 Class I JagRma LLC is recalling NuttZo Original Nut and Seed Butter because it may be contaminated with Salmonella. The affected products contain a peanut butter ingredient supplied by Sunland, Inc who is recalling due to Salmonella. Danielle Livolsi Jagrma
Food PureFit Peanut Butter Bars, size 2 oz (56.7g) and box of 15 bars in 1 box/carton. UPC 812787001008, 812787002005 01MAR13 and 12JUL13 Class I PureFit is recalling PureFit Peanut Butter Crunch Bars because of possible Salmonella. The peanut butter in the crunch bars was supplied by Sunland Inc., and it is on recall because it may be contaminated with Salmonella. PureFit Inc
Food Starbucks Protein Bistro Box, Net Wt 6.8 OZ (193g), Contains Cage-free egg, white Cheddar Cheese, multigrain muesli bread with honey peanut butter spread and fruit. Enjoy by Dates: 8/10/212-10/06/12 Best By Dates of Peanut Butter: 7/14/13; 7/26/13; 7/27/13; 7/28/13; 7/29/13; 8/9/13; 8/10/13; 8/13/13; 8/14/13; 8/15/13; 8/26/13; 8/27/13; 8/28/13; 8/29/13; 8/30/13 Class I Starbucks Protein Bistro Boxes contain Honey Peanut Butter Squeeze Packs which are involved in Justin's Nut Butter expanded recall. Flying Food Group, Inc.
Food Hannaford Red Velvet Cake Truffle, 6 count UPC #20335800000 All sell by dates Class I Product labels fails to declare allergens: egg, milk, peanuts, wheat, soy and tree nuts Hannaford Bros.
Food Hannaford Triple Chocolate Cake Truffle, 6 count UPC # 20335700000 All sell by dates Class I Product labels fails to declare allergens: egg, milk, peanuts, wheat, soy and tree nuts Hannaford Bros.
Food Su-Nun Crushed Roasted Thai Red Pepper, 10.58 oz. 12 jars/case. Packaged in clear plastic jars, red plastic screw on lid, with a red and yellow label. The principal display label has a red background with a yellow oval that reads in part:"SU-NUN***BRAND***HOT***CRUSHED ROASTED THAI RED PEPPER". Label on the back reads in part:"MANUFACTURED BY KHUN NAN CURRY PASTE FACTORY 149/375 Moo 13, Soi Pacific, Settakit Road, omm-Noi, Kratumband, Samutsakhon, 74130, Thailand***". No expiration date listed. No lot codes. Only UPC code: 659613000770. Distribution dates July 2012 to October 2012. No expiration date listed. Class I The recall was initiated in response to positive Salmonella resuts during FDA routine import sampling of the product. S & P Company Limited
Food Penn State Creamery/Berkey Creamery Ice Cream -- Black Raspberry flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic) Best by dates falling on or between February 10, 2013 and August 11, 2013. Class II Erring on the side of caution and safety for the consuming public, the University Creamery at Penn State is voluntarily recalling all ice cream and frozen yogurt made between May 16, 2012 and August 11, 2012 because of isolated incidents involving reports of small plastic foreign objects in the product. Pennsylvania State University Berkey Creamery
Food Penn State Creamery/Berkey Creamery Ice Cream -- Scholar's Chip flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic) Best by dates falling on or between February 10, 2013 and August 11, 2013. Class II Erring on the side of caution and safety for the consuming public, the University Creamery at Penn State is voluntarily recalling all ice cream and frozen yogurt made between May 16, 2012 and August 11, 2012 because of isolated incidents involving reports of small plastic foreign objects in the product. Pennsylvania State University Berkey Creamery
Food Penn State Creamery/Berkey Creamery Ice Cream -- Strawberry-No Sugar Added flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic) Best by dates falling on or between February 10, 2013 and August 11, 2013. Class II Erring on the side of caution and safety for the consuming public, the University Creamery at Penn State is voluntarily recalling all ice cream and frozen yogurt made between May 16, 2012 and August 11, 2012 because of isolated incidents involving reports of small plastic foreign objects in the product. Pennsylvania State University Berkey Creamery
Food Penn State Creamery/Berkey Creamery Ice Cream -- Keeny Beany Chocolate flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic) Best by dates falling on or between February 10, 2013 and August 11, 2013. Class II Erring on the side of caution and safety for the consuming public, the University Creamery at Penn State is voluntarily recalling all ice cream and frozen yogurt made between May 16, 2012 and August 11, 2012 because of isolated incidents involving reports of small plastic foreign objects in the product. Pennsylvania State University Berkey Creamery
Food Penn State Creamery/Berkey Creamery Ice Cream -- German Chocolate Cake flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic) Best by dates falling on or between February 10, 2013 and August 11, 2013. Class II Erring on the side of caution and safety for the consuming public, the University Creamery at Penn State is voluntarily recalling all ice cream and frozen yogurt made between May 16, 2012 and August 11, 2012 because of isolated incidents involving reports of small plastic foreign objects in the product. Pennsylvania State University Berkey Creamery
Food Penn State Creamery/Berkey Creamery Ice Cream -- Cookies-N-Cream flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic) Best by dates falling on or between February 10, 2013 and August 11, 2013. Class II Erring on the side of caution and safety for the consuming public, the University Creamery at Penn State is voluntarily recalling all ice cream and frozen yogurt made between May 16, 2012 and August 11, 2012 because of isolated incidents involving reports of small plastic foreign objects in the product. Pennsylvania State University Berkey Creamery
Food Penn State Creamery/Berkey Creamery Ice Cream -- Chocolate Chip Cookie Dough flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic) Best by dates falling on or between February 10, 2013 and August 11, 2013. Class II Erring on the side of caution and safety for the consuming public, the University Creamery at Penn State is voluntarily recalling all ice cream and frozen yogurt made between May 16, 2012 and August 11, 2012 because of isolated incidents involving reports of small plastic foreign objects in the product. Pennsylvania State University Berkey Creamery
Food Penn State Creamery/Berkey Creamery Ice Cream -- Chocolate Chocolate Nut flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic) Best by dates falling on or between February 10, 2013 and August 11, 2013. Class II Erring on the side of caution and safety for the consuming public, the University Creamery at Penn State is voluntarily recalling all ice cream and frozen yogurt made between May 16, 2012 and August 11, 2012 because of isolated incidents involving reports of small plastic foreign objects in the product. Pennsylvania State University Berkey Creamery
Food Penn State Creamery/Berkey Creamery Ice Cream -- Strawberry flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic) Best by dates falling on or between February 10, 2013 and August 11, 2013. Class II Erring on the side of caution and safety for the consuming public, the University Creamery at Penn State is voluntarily recalling all ice cream and frozen yogurt made between May 16, 2012 and August 11, 2012 because of isolated incidents involving reports of small plastic foreign objects in the product. Pennsylvania State University Berkey Creamery
Food Penn State Creamery/Berkey Creamery Ice Cream -- Strawberry Cheesecake flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic) Best by dates falling on or between February 10, 2013 and August 11, 2013. Class II Erring on the side of caution and safety for the consuming public, the University Creamery at Penn State is voluntarily recalling all ice cream and frozen yogurt made between May 16, 2012 and August 11, 2012 because of isolated incidents involving reports of small plastic foreign objects in the product. Pennsylvania State University Berkey Creamery
Food Penn State Creamery/Berkey Creamery Frozen Yogurt - Vanilla flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic) Best by dates falling on or between February 10, 2013 and August 11, 2013. Class II Erring on the side of caution and safety for the consuming public, the University Creamery at Penn State is voluntarily recalling all ice cream and frozen yogurt made between May 16, 2012 and August 11, 2012 because of isolated incidents involving reports of small plastic foreign objects in the product. Pennsylvania State University Berkey Creamery
Food Penn State Creamery/Berkey Creamery Frozen Yogurt - Strawberry flavor; 3 gallon (paper), 1/2 gallon (paper), and pints (plastic) Best by dates falling on or between February 10, 2013 and August 11, 2013. Class II Erring on the side of caution and safety for the consuming public, the University Creamery at Penn State is voluntarily recalling all ice cream and frozen yogurt made between May 16, 2012 and August 11, 2012 because of isolated incidents involving reports of small plastic foreign objects in the product. Pennsylvania State University Berkey Creamery
Food Green & Black's Organic Peanut & Sea Salt Milk Chocolate Bar NET WT. 3.5 oz (100g). UPC 708656 100562. UPC - 708656 100562; Code Dates: Oct 26, 2012; Oct 27, 2012; Oct 30, 2012; Nov 1, 2012. Class I Mondelez Global LLC (Mondelez Global) is voluntarily recalling the U.S. Green & Black's Organic Peanut & Sea Salt Milk Chocolate Bar (3.5 oz.) in response to the recently expanded recall of certain peanut products by Sunland Inc., Portales, NM (Sunland). This product contains peanuts supplied by Sunland. According to Sunland, the peanuts may be contaminated with Salmonella. Mondelez Global Llc
Food Ridgebar Peanut Butter Crunch, 40 grams UPC : 855468003052, Best by dates: 022413, 042813 Class I Creative Energy Foods manufactured nutrition bars with peanuts from Sunland, Inc which are under recall for the potential to be contaminated with salmonella. Creative Energy Foods, Inc. LLC
Food Peanut Butter Cup Ice Cream: 1) Velvet Supreme Peanut Butter Cup 1/2 gallon MFD BY VELVET ICE CREAM CO., INC UTICA, OHIO 43080 1-800-589-5000; UPC #70682-10119; 2) Velvet Peanut Butter Cup, 3 gal, UPC #70682-10539 1 and 2 - Code Number #10181, MFD Date: 6/30/2010 Class I The product was manufactured using peanut butter ingredient recalled by Sunland Inc. due to potential Salmonella contamination. Velvet Ice Cream Company
Food Velvet Buckeye Classic MFD BY VELVET ICE CREAM CO., INC UTICA, OHIO 43080 1-800-589-5000 56 oz (UPC #70682-10038), 3 gallon (UPC #70682-10519) and pints (UPC #70682-10423) UPC #70682-10038 Code Number # 10193 MFD Date: 7/12/2010--56oz UPC #70682-10519 Code Number #10193 MFD Date: 7/12/2010- 3 gallon UPC #70682-10519 Code Number #12207 MFD Date: 7/25/2010--3 gallon UPC #70682-10519 Code Number #12227 MFD Date: 8/14/2010-- 3 gallon UPC #70682-10423 Code Number #12251 MFD Date: 9/07/2010--pints Class I The product was manufactured using peanut butter ingredient recalled by Sunland Inc. due to potential Salmonella contamination. Velvet Ice Cream Company
Food Turkey Hill Mint Chocolate Chip All Natural Ice Cream, 48 oz, UPC 0-20735-11203-8 UPC 0-20735-11203-8 with Sell By Code: 09/28/2013 42-092 L3/56 Affected Production Time: 05:58 AM to 06:30 AM Class II The product contains undeclared coconut. Turkey Hill Dairy, Inc.
Food Nutrition bar. Crunch® thinkThin Brand, Mixed Nuts, 40 grams. Packaged in plastic, labeled as:"Distributed by thinkproducts***Ventura, CA 93003***". 10 bars/carton, 12 cartons/case. 120 bars per case UPC Code: 7 53656 70840 9 Best by Dates: 101812, 110912, 120112, 022813, 040413, 041913, 050913, 051513, 052313, 060113, 060813, 061313. 062713, 070913 AND expired lots prior to Best By 101012 Class I The firm inititated the recall of Crunch® thinkThin nutrition bars which may contain blanched roasted peanuts supplied by Sunland , Inc and have the potential to be contaminated with Salmonella. Think Thin, LLC
Food Nutrition bar. Crunch® thinkThin Brand, White Chocolate Dipped Mixed Nuts, 40 grams. Packaged in plastic, labeled as:"Distributed by thinkproducts***Ventura, CA 93003***". 10 bars/carton, 12 cartons/case. 120 bars per case UPC Code: 7 53656 70861 4 Best by Dates: 030113 ,032513, 042013, 052213, 060113, 061513, 062213 AND expired lots prior to Best By 101012 Class I The firm inititated the recall of Crunch® thinkThin nutrition bars which may contain blanched roasted peanuts supplied by Sunland , Inc and have the potential to be contaminated with Salmonella. Think Thin, LLC
Food Nutrition bar. Crunch® thinkThin Brand, Chocolate Dipped Mixed Nuts, 40 grams. Packaged in plastic, labeled as:"Distributed by thinkproducts***Ventura, CA 93003***". 10 bars/carton, 12 cartons/case. 120 bars per case UPC Code: 7 53656 70843 0 Best by Dates: 101812, 102612, 110812, 110912, 120312, 030713, 030813, 031613, 032513, 041213, 041313, 042113, 042513, 042813, 051213, 052313, 052413, 060713, 061413, 062613, 062813, 071813 AND expired lots prior to Best By 101012 Class I The firm inititated the recall of Crunch® thinkThin nutrition bars which may contain blanched roasted peanuts supplied by Sunland , Inc and have the potential to be contaminated with Salmonella. Think Thin, LLC
Food Nutrition bar. Crunch® thinkThin Brand, Caramel Chocolate Dipped Mixed Nuts, 40 grams. Packaged in plastic, labeled as:"Distributed by thinkproducts***Ventura, CA 93003***". 10 bars/carton, 12 cartons/case. 120 bars per case UPC Code: 7 53656 70879 9 Best by Dates: 112812, 030813, 040513, 042113, 051013, 060113, 061513, 071313 AND expired lots prior to Best By 101012 Class I The firm inititated the recall of Crunch® thinkThin nutrition bars which may contain blanched roasted peanuts supplied by Sunland , Inc and have the potential to be contaminated with Salmonella. Think Thin, LLC
Food Nutrition bar. Crunch® thinkThin Brand, Cherry & Mixed Nuts, 40 grams. Packaged in plastic, labeled as:"Distributed by thinkproducts***Ventura, CA 93003***". 10 bars/carton, 12 cartons/case. 120 bars per case UPC Code: 7 53656 70915 4 Best by Dates: 022313, 032513, 041913, 042513, 061113 AND expired lots prior to Best By 101012 Class I The firm inititated the recall of Crunch® thinkThin nutrition bars which may contain blanched roasted peanuts supplied by Sunland , Inc and have the potential to be contaminated with Salmonella. Think Thin, LLC
Food Nutrition bar. Crunch® thinkThin Brand, Blueberry & Mixed Nuts, 40 grams. Packaged in plastic, labeled as:"Distributed by thinkproducts***Ventura, CA 93003***". 10 bars/carton, 12 cartons/case. 120 bars per case UPC Code: 7 53656 70906 2 Best by Dates: 111812, 022313, 022413, 032813, 040413, 042113, 051813, 051913, 060813, 062713, 062813, 071913 AND expired lots prior to Best By 101012 Class I The firm inititated the recall of Crunch® thinkThin nutrition bars which may contain blanched roasted peanuts supplied by Sunland , Inc and have the potential to be contaminated with Salmonella. Think Thin, LLC
Food Nutrition bar. Crunch® thinkThin Brand, Cranberry Apple & Mixed Nuts, 40 grams. Packaged in plastic, labeled as:"Distributed by thinkproducts***Ventura, CA 93003***". 10 bars/carton, 12 cartons/case. 120 bars per case UPC Code: 7 53656 70909 3 Best by Dates: 030813, 041113, 052913, 062213 AND expired lots prior to Best By 101012 Class I The firm inititated the recall of Crunch® thinkThin nutrition bars which may contain blanched roasted peanuts supplied by Sunland , Inc and have the potential to be contaminated with Salmonella. Think Thin, LLC
Food Dole American Blend; Iceberg, Romaine, Red Cabbage, Carrots and Radishes. Net Wt. 12 oz. (340g) UPC 0 71430 00933 8 Distributed by Dole Fresh Vegetables, Monterey, CA 93940 Code: A275208A or B275208B; Enjoy by Date: 10-17-12. Class I Tennessee Department of Agriculture collected a random sample of Dole American Blen and had a positive result for Listeria Monocytogenes. Dole Fresh Vegetables Inc
Food Earthbound Farms Organic Baby Spinach Grab & Go Salad; with sesame, soy vinaigrette and peanuts. USDA Organic 3.5 oz. Clamshell package. UPC 0 32601 08875 0 Natural Selection Foods San Juan Bautista, CA. Best if Used by Dates: 10/17-12 through 10/28/12. Class I Peanuts packaged with EarthBound Baby Spinach Grab & Go Salad were provided by Sunland through a third party and are under recall due to potential Salmonella contamination. Natural Selection Foods LLC dba Earthbound Farm
Food Peanuts in Shell, R&S, 8oz, Item#304, 12pk/case, UPC 070334003046. Peanuts in Shell, R&S, 8oz, Item#304P, 12pk/case, UPC 170334003046. Peanuts in Shell, R&S, 8oz, Item#307, 36pk/case, UPC 070334003046. Peanuts in Shell, R&S, 16oz, Item#317, 24pk/case, UPC 070334003176. Peanuts in Shell, R&S Clip Strips, Item#327, 8oz, 4/12 pk/case, UPC 070334003046. Peanuts in Shell, R&S, 4.5oz, Item#334, 12pk/case, UPC 070334003305. Peanuts in Shell, R&S, Display Ready, 8oz, Item#360, 12pk/case, UPC 070334003046. Peanuts in Shell, R&S, 3lbs, Item#383, 8pk/case, UPC 070334003831. Peanuts in Shell, R&S, 3lbs, Item#530, 60pk/case, UPC 170334005309. Peanuts in Shell, R&S, 3lbs, Item#530V, 60pk/case, UPC 070334005309. Peanuts in Shell, R&S, 3lbs, Item#530VP, 60pk/case, UPC 070334005309. Peanuts in Shell, R&S, 7.5lbs, Item#1950, 24pk/case, UPC 052679019500. Best By Date 11/23/2012 to 04/10/2013 Class I Trifecta Foods, LLC in Pacoima, CA is voluntarily recalling products containing In-Shell Roasted Salted and Unsalted Peanuts supplied to Trifecta Foods by Sunland, Inc. because they may be contaminated with Salmonella. Energy Club Inc
Food Peanuts in Shell, R Unsalted, 8oz, Item#305, 12pk/case, UPC 070334003053. Peanuts in Shell, R Unsalted, 8oz, Item#308, 36pk/case, UPC 070334003053. Peanuts in Shell, R Unsalted, 16oz, Item#318, 24pk/case, UPC 070334003189. Peanuts in Shell, R Unsalted-Display Ready, 8oz, Item#361, 12pk/case, UPC 070334003053. Peanuts in Shell, R Unsalted, 3lbs, Item#384, 8pk/case, UPC 070334003848. Peanuts in Shell, R Unsalted-Caddies, 3oz, Item#535, 8/12pk/case, UPC 070334005354. Best by Date 11/23/12 to 4/10/13. Class I Trifecta Foods, LLC in Pacoima, CA is voluntarily recalling products containing In-Shell Roasted Salted and Unsalted Peanuts supplied to Trifecta Foods by Sunland, Inc. because they may be contaminated with Salmonella. Energy Club Inc
Drugs AcneFree 24 Hour Clearing System containing 1-count 4 fl oz (118 mL) Oil-Free Purifying Cleanser (benzoyl peroxide 2.5% w/v) AFCS-0101-00, 1-count 4 fl oz (118 mL) Renewing Toner AFCS-0201-01, and 1-count 2 fl oz (59 mL) Repair Lotion (benzoyl peroxide 3.7% w/v) AFCS-0301-00 per carton, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 12008 6. All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12008 6 Class III Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label. Valeant Pharmaceuticals
Drugs AcneFree 24 Hour Severe Acne Clearing System containing 1-count 4 fl oz (118 mL) bottle Antibacterial Cleansing Wash (benzoyl peroxide 2.5% w/v) AFSV-0101-00, 1-count 4 fl oz (118 mL) bottle Corrective Toner AFSV-0201-01, 1-count 2 fl oz (59 mL) bottle Maximum Strength Repair Lotion (benzoyl peroxide 10% w/v) AFCS-0303-00, and 1-count 1 oz (28 g) bottle AFSV-0305-03, Retinol Renewal Complex per carton, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 12900 3. All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12900 3 Class III Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label. Valeant Pharmaceuticals
Drugs AcneFree Oil-Free Acne Cleanser (benzoyl peroxide 2.5% w/v), 8 fl. oz. (237 mL) bottle, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, AFCS-0101-00, UPC 7 88521 12020 8. All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12020 8 Class III Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label. Valeant Pharmaceuticals
Drugs AcneFree Original Strength Terminator (benzoyl peroxide 5% w/v), 1 oz. (28 g) tube, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, AFCS-0402, UPC 7 88521 12030 7. All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12030 7 Class III Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label. Valeant Pharmaceuticals
Drugs AcneFree Acne Astringent Toner Pads (salicylic acid 2% w/v); 60-count pads per jar, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13551 6. All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 13551 6 Class III Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicyclic acid active ingredient. Valeant Pharmaceuticals
Drugs AcneFree 3-in-1 Acne Night Repair Foam (retinol + salicylic acid 1.5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13548 6. All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 13548 6 Class III Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicylic acid ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label. Valeant Pharmaceuticals
Drugs AcneFree Severe Maximum Strength Acne Pore Cleanser (benzoyl peroxide 5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13350 9. All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 13550 9 Class III Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label. Valeant Pharmaceuticals
Drugs AcneFree Acne Pore Cleanser (benzoyl peroxide 2.5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13546 2. All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 13546 2 Class III Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label. Valeant Pharmaceuticals
Food Fiesta Mix 25 pound bags, with UPC 032491208597. The product is labeled in part: "***Fiesta Mix A Blend of the Sweet Crunchy and Salty Ingredient: Peanuts, honey, chili bits, corn, goldfish, nacho flavoring, vegetable oil, salt. *** 25 pounds (11.34 kg) net weight *** The Nut Factory 19425 East Broadway Avenue Greenacress, WA 99016***". Dates of distribution: 1/1/12 thorugh and including 10/17/12 Fiesta Mix label Date Manuactured: In format of date, first three letters of the month and year (2012). Class I Fiesta Mix product is recalled due to undeclared soy, milk, wheat, and FD& C Yellow #6 on finished product label. The Nut Factory Inc.
Devices The touchscreen display (model 94267) designed for use with the XPREZZON bedside monitor (model 91393) is width-452 mm (17.2 inches) and height- 368 mm (14.5 inches). The depth without the pedestal --- 67.7 mm (2.67 inches). The display is an integrated LCD 19-Inch. The Spacelabs Healthcare Xprezzon Bedside Monitor passively displays data generated by Spacelabs parameter modules. Serial Number for U.S. Cosignees: PRO-12240004, PRO-12240015, PRO-12240017, PRO-12240018, PRO-12240022, PRO-12240026, PRO-12240028, PRO-12240030, PRO-12240031, PRO-12240032, PRO-12240033, PRO-12240034, PRO-12240036, PRO-12240037, PRO-12240038, PRO-12240040, PRO-12240041, PRO-12240058, PRO-12240059, PRO-12240062, PRO-12240063, PRO-12240077, PRO-12240084, PRO-12240090, pro-12260008, PRO-12260016, pro-12260018, PRO-12260023, pro-12260024, PRO-12260032, pro-12260033, pro-12260035, PRO-12260036, PRO-12260037, pro-12260038, pro-12260041, pro-12260044, pro-12260055, pro-12260059, PRO-12260060, PRO-12260062, pro-12260064, pro-12260065, pro-12260068, pro-12260070,  ...
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Class II Potential failure of Spacelabs Healthcare Touchscreen Display, Model 94267 where the alarm lights failed to illuminate upon installation. Spacelabs Healthcare, Llc
Food Starbucks brand Protein Bistro Box. cage free egg, white cheddar cheese, multigrain muesli bread, apple slices, red grapes and peanut butter packet. Net weight: 6.8 oz. Starbucks Bistro box UPC 762111881502; Justin's honey Peanut Butter blend UPC 894455000391. Honolulu Baking Co. Honolulu, HI 96813 Enjoy By Dates of 9-2-10 - 3-28-12 and 9-1-12 - 10-1-12. for Bistro Boxes. Best Buy Dates for peanut packets: 4/11/11 _ 12/7/12; 7/27/13 and 7/29/13. Class I Firm used recalled 0.5 oz., single serve squeeze packs of Honey Peanut Butter in their Starbucks Brand Protein Bistro Packs which have been implicated in the Sunland Inc recall. Honolulu Baking Company, Ltd.
Food Peanut brittle, 2 lbs packaged in plastic bags (bulk product) all date codes between 09/30/2012 - 10/04/2012 Class I Products were manufactured using peanuts recalled by Sunland Southern Belle, Inc.
Food Bacon Brittle, 2 lbs packaged in plastic bags (bulk product) all date codes between 09/30/2012 - 10/04/2012 Class I Products were manufactured using peanuts recalled by Sunland Southern Belle, Inc.
Devices AMS AdVance" Male Sling System 720088-01 AMS AdVance" Male Sling System (US) 720088-02 AMS AdVance" Male Sling System (Intl) 72404224 AMS Male TO Sling System (Intl). The AMS AdVance Male Sling System is intended for the placement of a suburethral sling for the treatment of male stress urinary incontinence (SUI). Part # Lot/Serial Range 720088-01 722022001 to 796127002 720088-02 722024001 to 790266012 72404224 742528001 to 795689010 Class II American Medical Systems® (AMS) is issuing a voluntary recall on a number of lots of the AdVance® Male Sling System (AdVance). AMS has recently received a small number of complaints regarding the resorbable suture in the AdVance sling not lasting for the entire 15 month shelf life of the product. An internal investigation has been conducted and confirmed that some sutures degraded prior to the expiration of the labeled shelf life. At this time AMS cannot confirm that there is no potential for premature degradation of the bioabsorbable tensioning sutures on the product included in this recall. American Medical Systems, Inc.
Food The Nut Shop (brand) Roasted Peanuts, 3.0 oz MIN Wt. The product is not coded. All product on the shelf as of October 18, 2012 Class I Product manufactured using peanuts which were recalled by Sunland. Williams and Company Inc dba The Nut Shop
Devices ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is a sterile, single use, surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. Product Code 95221 - All lot numbers beginning with: AH9284*** to AH9356***, AH0007*** to AH0356***, AH1008 *** to AH1364***, AH2006*** to AH2146*** Class II Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled. Kimberly-Clark Corporation
Devices MicroCool Breathable Gown with Towels, X-Larg, X-Long, Sterile The product is a sterile, single use, surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. Product Code 92042 - All lot numbers beginning with: AH9282*** to AH9309***, AH0013*** to AH0329***, AH1020 *** to AH1293***, AH2019*** to AH2175*** Class II Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled. Kimberly-Clark Corporation
Devices TI Standard Polyaxial Screw Assembly 6.5MM x 55MM. Part # 62065-55. Subsequent Product Codes: MNH, MNI. The Zodiac Polyaxial Pedicle Screw System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies in the thoraco-lumbo-sacral portion of the spine. It intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac Polyaxial Pedicle Screw System are dependent in part on the configuration of the assembled device and the method of attachment to the spine. Lot # 634745 Class II The recall was initiated because Alphatec Spine confirmed that the TI Standard Polyaxial Screw Assembly was laser marked with the incorrect length of 45 MM. Alphatec Spine, Inc.
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