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U.S. Department of Health and Human Services

Enforcement Report - Week of December 4, 2013

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Red Blood Cells Leukocytes Reduced 07GQ20577, 07GQ20578 Class III Blood products, collected using scales for which the quality control testing was performed incorrectly, were distributed. American National Red Cross (The)
Biologics Source Plasma 0460004858, 0460004635, 0460002270, YA190229, YA190136, YA189991, YA189818, YA189516, YA189428, YP221933, YP221853, YP221708, YP221571, YP221411, YP221316, YP221195, YT115612, YT115410, YT115364, YT115279, YT115179, YT115115, YT114852, YT114706, YT114680, YT114576, YT114541, YT114440, YT114429, YT114324, YT114289, YT115037, YT114985 Class II Blood products, which tested negative for viral markers, but were collected from a donor who previously tested positive for the antibody to hepatitis C virus (anti-HCV), were distributed. Octapharma Plasma Inc
Biologics Source Plasma 05EWIA3253, 05OWIA2323, 04AIAE2883, 04FMOB2983, 04FMOB3477, 04FMOB3745 Class II Blood products, which were not quarantined after receiving information regarding the suitability of the donors, were distributed. BioLife Plasma Services L.P.
Biologics Source Plasma 05MUSA0255 Class II Blood product, which was not quarantined after receiving information regarding the donor's history of incarceration, was distributed. BioLife Plasma Services L.P.
Biologics Blood and Blood Products for Reprocessing 106671388 Class III Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Blood Systems, Inc.
Biologics Source Plasma YA182148 Class III Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed. Octapharma Plasma Inc
Biologics Red Blood Cells Leukocytes Reduced Irradiated 06FC44187; 06FR90216 Class II Blood products, not prepared in accordance with product specifications, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced Irradiated 07FR32612 Class II Blood products, possibly contaminated with air, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 07FY73202; 07FY73208 Class II Blood products, possibly contaminated with air, were distributed. American National Red Cross (The)
Biologics Plasma Frozen 07FY73199 Class II Blood products, possibly contaminated with air, were distributed. American National Red Cross (The)
Biologics Source Plasma 0530530359; 0530516500; 0530513651; 0530513199; 0530511972;  ...
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Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. CSL Plasma
Biologics Platelets Pheresis Leukocytes Reduced 72H626599 Class II Blood product, which did not meet acceptable product specifications, was distributed. LifeSouth Community Blood Centers, Inc.
Biologics Source Plasma 366000791;366000843 Class II Blood products, collected from a donor who was previously deferred, were distributed. Talecris Plasma Resources, Inc.
Biologics Source Plasma 3590016002, 3590021668, 3590022785, 3590000240, 3590023613, 3590023941, 3590017527, 3590018181, 3590018916, 3590022690, 3590023013, 3590014854, 3590015970, 3590016712, 3590020289, 3590022447, 3590017463, 3590018993, 3590022352, 3590026746, 3590017453, 3590018487, 3590019512, 3590019636, 3590017201, 3590020313, 3590020142, 3590022234, 3590019687, 3590023098, 3590000219, 3590017352, 3590018201, 3590018422, 3590018735, 3590019766, 3590020403, 3590014433, 3590015114, 3590022965, 3590020592, 3590023754, 3590023892, 3590016729, 3590018222, 3590016290, 3590016785, 3590017487, 3590018260, 359025223,  ...
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Class III Blood products, collected from donors whose suitability was not adequately determined, were distributed. Talercris Plasma Resources, Inc.
Biologics Source Plasma 41501223685 41501222076 41501220759 41501237868 41501237067 41501233971 41501236259 41501238019 41501236814 41501238414 41501235459 41501233613 41501234392 41501235942 41501230746 41501231685 41501230834 41501232565 41501230172 41501219416 41501216899 41501219248 41501211852 41501212628 41501119693 41501213209 41501119896 41501119642 41501212290 41501119984 41501212070 41501117794 41501118105 41501117209 41501119360 41501116812 41501118914 41501117217 41501117399 41501116919 41501117276 41501118287 41501117962 41501119490 41501119300 41501119482 41501117145 41501119116 41501117508 41501117153  ...
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Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. CSL Plasma, Inc.
Devices Synthes Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Body, Part Number 04.631.500 Non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. All lots Class II This action is being initiated following a detailed investigation in response to reported complaints of post-operative locking cap loosening. Synthes has concluded that if the construct is mis-aligned during final tightening, the potential exists for locking caps to loosen post-operatively in certain situations. Synthes USA HQ, Inc.
Devices Synthes Titanium Minimally Invasive Reduction Screw System Locking Cap, Part Number 04.631.502 Non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. All lots Class II This action is being initiated following a detailed investigation in response to reported complaints of post-operative locking cap loosening. Synthes has concluded that if the construct is mis-aligned during final tightening, the potential exists for locking caps to loosen post-operatively in certain situations. Synthes USA HQ, Inc.
Biologics Red Blood Cells Leukocytes Reduced Irradiated 06GC87581, 06LX14390 Class II Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 06FE46787, 06GF94083, 06GG21093, 06GL18878, 06GQ85696, 06GV96048, 06LQ17871, 06FC75130, 06GC87474, 06GH46640, 06GL20950, 06LW15617, 06GX02769, 06GQ88411, 06FC75119, 06GF01602, 06FR20160, 06FR20163, 06GC88963, 06GE52114, 06GK63347, 06GK63399, 06GQ89307, 06GW71782, 06GW71965, Class II Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. American National Red Cross (The)
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 06GE48899, 06GS58424, 06GF02674, 06GC85007 Class II Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. American National Red Cross (The)
Veterinary WAT Partridge Grower, AVT133, Product No. 37465. Medicated Complete Partridge Grower. Active Drug Ingredient: Lasalocid 113 g/ton. Hubbard Feeds, Inc. General Offices, Mankato, MN 56002-8500 Batch number B00578501 Class I The one customer complained that after feeding the bird chicks for a few days he noticed they were not eating. Additionally, approximately 150 bird chicks died from the pen of 1,500 at the game farm. Ridley Block Operations, Inc.
Devices 20mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC2000 Product is intended for fluid transfer between a Partial Additive Bag (PAB(R)) container and a drug vial. Material BC2000, Lot numbers 0061275133, 0061275135, 0061275136, 0061279143, 0061279144, 0061279145, 0061279146, 0061289059, 0061289060, 0061289061, 0061289062, 0061289063, 0061289064, 0061289065, 0061289066, 0061289067 and 0061299664. Class II Possible solution leakage at the interface of the addEASE(TM) Binary Connector (Product Codes BC2000 and BC1300) and the PAB(R) bag. Based on extensive root cause investigation, it has been determined that the leakage is the result of a misaligned cannula (needle) on the addEASE(TM) Binary Connector, which pierces the PAB(R) bag stopper to access the solution. The misaligned cannula may result in an inadequate seal at the cannula and stopper interface and ultimately may cause solution leakage. B. Braun Medical, Inc.
Devices 13mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC1300 Product is intended for fluid transfer between a Partial Additive Bag (PAB(R)) container and a drug vial. Material BC1300, Lot number 61286479. Class II Possible solution leakage at the interface of the addEASE(TM) Binary Connector (Product Codes BC2000 and BC1300) and the PAB(R) bag. Based on extensive root cause investigation, it has been determined that the leakage is the result of a misaligned cannula (needle) on the addEASE(TM) Binary Connector, which pierces the PAB(R) bag stopper to access the solution. The misaligned cannula may result in an inadequate seal at the cannula and stopper interface and ultimately may cause solution leakage. B. Braun Medical, Inc.
Veterinary Wardley Betta Fish Food 1.2 oz Made in the USA by The Hartz Mountain Corporation, Secaucus, New Jersey 07094 and imported by Canada Inc., St. Thomas, Ontario N59 3W7, Canada UPC number 0-43324-01648 Lot Code PP06331 Class I The Hartz Mountain Corporation, located in Secaucus, N.J. is voluntarily recalling one specific lot of Wardley Betta Fish Food 1.2 oz. size due to concerns that one or more containers within the lot may have been potentially contaminated with Salmonella. Hartz Mountain Corp.
Drugs J.R. Jack Rabbit All Natural Herbal Supplement, One tablet can last 24-72 hours, 4-count tablets per blister pack, Order at: www.jackrabbitfourpack.com, Jack Rabbit Inc., 4355 Dow Road, Melbourne, FL 32934 Lot #: 2510 Exp 04/01/15 Class I Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that J.R. Jack Rabbit Male Enhancement product was found to contain two undeclared active pharmaceutical ingredients: sildenafil and tadalafil. Jack Rabbit, Inc
Devices Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector. Multiple serial numbers Class II Certain System 83 Plus 2 and System 83 Plus 9 units running the Windows 7 operating system were not fully validated prior to distribution. Custom Ultrasonics, Inc.
Drugs Cetacaine Liquid Topical Anesthetic, Rx Only, a) 14 g bottle (NDC 10223-0202-2); Kit w/14 g (NDC 10223-0202-3); 30 g bottle (NDC 10223-0202-4) Manufactured by Cetylite Industries, Inc., 9051 River Road Pennsauken, NJ 08110 - Lot 470 exp. 04/13, 471 exp. 06/13, 472 exp. 10/13 Class II Subpotent Drug: Cetacaine Topical Anesthetic Liquid is being recalled because one of the three active ingredients, tetracaine, is below the specification limit at the 21 month stability test point. Cetylite Industries, Inc.
Devices (Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10 Image intensified fluoroscopic x-ray system Model numbers: 10094200, 10094910, 10281013, 10281163, 10502200 Class II A potential malfunction and hazard to patients exists when using the Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10, which may result in radiation continuing longer than required and overexposed images that are not of diagnostic quality. Siemens Medical Solutions USA, Inc
Drugs Loratadine, USP 10 mg, Antihistamine, packaged in blister packs. All manufactured by Novartis Consumer Health, Inc, Lincoln, NE / There are 7 different labels under which this product is packaged but the active ingredient is the same. 1) DOLLAR GENERAL LABEL: DG Health Allergy Relief, Loratadine, USP 10 mg, Antihistamine, packaged in 60 tablet blister packs (UPC code: 300436122) and 30 tablet blister packs (UPC code: 300676122304). Distributed by Dolgencorp, LLC, Goodlettsville, TN. 2) FAMILY DOLLAR LABEL: Family Wellness Allergy Relief, Loratadine, USP 10 mg, Antihistamine, packaged in 30 tablet blister packs (UPC code: 032251004292). Distributed by Family Dollar Services, Inc, Matthews, NC. 3) FAMILY DOLLAR LABEL Family Dollar Allergy Relief, Loratadine, USP 10 mg, Antihistamine, packaged in 30 tablet blister packs (UPC code: 400910131502). Manufactured by Novartis Consumer Health, Inc, Lincoln, NE and Distributed by Family Dollar Services, Inc, Charlotte, NC. 4) TARGET LABEL: Allergy Relief Medication, loratadine, 10 mg/antihistamine, packaged in 10 tablet (UPC 300670675103), 15 tablet (UPC 300670668150), 30 tablet (UPC 300670675301), 40 tablet (UPC 300670675400), and 60 tablet (UPC 300670675004) blister packs. It is also packaged in 120 tablet (UPC 300670675127) and 180 tablet (UPC 300676255736) bottles. Dist. by Target Corporation, Minneapolis, MN. 5) PRIVATE LABEL: Loratadine 10mg, Antihistamine, packaged in 10 tablet (UPC 300670674106) and 30 tablet (UPC 300670674304) blister packs. Manufactured and Distributed by: Novartis Consumer Health, Inc., Lincoln, NE. 6) WALMART LABEL, Equate, Allergy Relief, Loratadine Tablets, 10 mg, Antihistamine, packaged in 10 tablet (UPC 681131739276) and 30 tablet (UPC 681131739283) blister packs. Distributed by: Wal-Mart Stores, Inc., Bentonville, AR. 7) CVS LABEL: CVS Pharmacy, Allergy Relief, Loratadine 10mg/Antihistamine, packaged in 5 tablet (UPC 050428068595), 10 tablet (UPC 050428046784), 20 tablet (UPC 050428065747) (UPC 050428579350), and 30 tablet (UPC 050428046791) blister packs. Also packaged in 120 tablet (UPC 050428065822) and 365 tablet (UPC 050428160282) plastic bottles. Manufactured by: Novartis Consumer Health, Inc., Lincoln, NE, for: CVS Pharmacy, Inc., Woonsocket, RI. 1) DG Health Allergy Relief 60 tablet packages: Lot 10114571, exp 4/14 and  ...
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Class III Failed Tablet/Capsule Specifications: The products are being recalled due to chipped and broken tablets. Novartis Consumer Health
Biologics Source Plasma 3510256577 Class II Blood product, collected from a donor who received a tattoo within one year of donation, was distributed. Talecris Plasma Resources Inc
Devices Siemens RAD Fluoro Uro system (Luminos dRF and Uroskop Omnia with software version VD10A/G Image intensified Fluoroscopic X-ray system Model numbers 10094910 and 10094200 with software version VD10A/G. Class II When using systems operating with software versions VD10A/G during a RAD examination, a malfunction can result in radiation continuing longer than required resulting in an overexposed image that is not of diagnostic quality, prompting repetition of the examination. Siemens Medical Solutions USA, Inc
Drugs Acanya (Clindamycin Phosphate and Benzoyl Peroxide) Gel 1.2% and 2.5%. Rx Only, Net Wt 3.5 g, Sample - not for sale, CORIA Laboratories, a division of Valeant Pharmaceuticals LLC, Bridgewater, NJ 08807 --- NDC 13548-132-03 Lot AC27198F6 Class III Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being carried out due to an incorrect expiration date assigned to a lot of physicians samples. Valeant Pharmaceuticals North Am
Biologics Platelets Pheresis Leukocytes Reduced W20841380012200 Class II Blood product, which did not meet the acceptable product specifications for release, was distributed. American National Red Cross (The)
Devices Baxter, VIAL-MATE Adaptor, 2B8071, Rx Only, STERILE R, Baxter Healthcare Corporation, Deerfield, IL 30015 USA The VIAL-MATE is reconstitution device labeled for use with 20 mm drug vials and 50mL, 100mL, and 250mL Single Pack Mini Bags. Lot Number GR13G23028 Class II Incomplete foil seal on one lot of sterile product. Baxter Healthcare Corp.
Devices 2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone. Lot 3420620 Class II Specific lots of the SS 2.4mm and SS 2.7mm Locking Screw (self-tapping) due to a mislabeling issue. The SS 2.7mm Screw was labeled as SS 2.4 mm Screw. Synthes USA HQ, Inc.
Devices Slipped Capital Femoral Epiphysis System Product Usage: Intended for fracture fixation of large bones and large bone fragments and for slipped capital femoral epiphysis, pediatric femoral neck fractures, intercondylar femur fractures and sacroiliac joint disruptions. Parts 03.207.001 and 03.207.008 with lot numbers: Part # Lot # 03.207.001 PE00376 PE00439 PE01391 PE01329 PE01412 PE00504 03.207.008 PE00440 PE00377 PE00513 PE01475 PE01691 Class II There is a possibility for the Guide Wires of the Slipped Capital Femoral Epiphysis System to stick in the cannulation of the drill bit and the drill bits to break during surgery. Synthes USA HQ, Inc.
Devices Synthes 2.4 mm LC-DCP Plate 6 Holes/51mm Product Usage: Intended for fractures, osteotomies, and replantations of small bones including the foot, ankle, and hand. Part No. 249.926, lot No. 8093100 Class II A complaint was reported regarding a screw being found in a package labeled for 2.4 mm LC-DCP Plate. Synthes USA HQ, Inc.
Devices Vertebroplasty Needle Kit 10g Diamond Tip Intended to be used to inject PMMA cement into vertebral bodies during Vertebroplasty procedure. Part No. 03.702.218S, Lot No. AJM838X Class II Complaints were received of inconsistencies in the expiration dates shown on the packaging of the Vertebroplasty Needle Kit 10g Diamond Tip device. Synthes USA HQ, Inc.
Devices Synthes Matrix Threaded Persuader Deformity is a comprehensive thoracolumbar pedical screw system designed to provide flexibility biomechanical performance and a solution to complex posterior pathological challenges. Item Lot Number Number 03.632.008 4833901 03.632.008 6284014 03.632.008 6284015 03.632.008 6377412 03.632.008 6390270 03.632.008 6390308 03.632.008 6390309 03.632.008 6445711 03.632.008 6455761 03.632.008 6455786 03.632.008 6530998 03.632.008 6548747 03.632.008 6558995 03.632.008 6559002 03.632.008 6583188 03.632.008 6583189 03.632.008 6603334 03.632.008 6603335 03.632.008 6624550 03.632.008 6676663 03.632.008 6703414 03.632.008 6706733 03.632.008 6718634 03.632.008 6718635 03.632.008 4833901 03.632.008 6445711 03.632.008 6455761 03.632.008 6455786 03.632.008 6530998 03.632.008 6548747 03.632.008 6603334 03.632.008 6603335 03.632.008 6676663 03.632.008 6703414 03.632.008 6706733 03.632.008 6718634 03.632.008 6718635 Class II Synthes became aware that during a procedure using the Matrix Threaded Persuader, the Reduction Insert malfunctioned causing pieces to break off. Once there is a breakage to the Reduction Insert it will not allow the instrument to function as required. Synthes USA HQ, Inc.
Devices Synthes Matrix 5.5.mm Left and Right Coronal Bender Product Usage: The Matrix 5.5.mm Left and Right Coronal Bender are used together to bend the 5.5 Matrix Rods in the coronal plane, and is intended for stabilization of the thoracic, lumbar, sacral, and/or iliac spine through screw and/or hook and rod fixation. Parts 03.632.040 and 03.632.041 with various lot nos. Item Lot Number Number 03.632.040 T935338 03.632.040 T939100 03.632.040 T945062 03.632.040 T953982 03.632.040 T956310 03.632.040 T959990 03.632.040 T959995 Item Lot Number Number 03.632.041 T935343 03.632.041 T939105 03.632.041 T939755 03.632.041 T945067 03.632.041 T952750 03.632.041 T956315 03.632.041 T960000 03.632.041 T960005 Class II A complaint was received of the tips of the Matrix 5.5.mm Left and Right Coronal Bender breaking while bending a spinal rod component of the Matrix System. Synthes USA HQ, Inc.
Devices Synthes 4.5 mm LCP Curved Condylar Plate Intended for buttressing multifragmentary distal femur fractures. Part No. 02.001.324, lot no. 6900823 Class II The Synthes 4.5 mm LCP Curved Condylar Plate was recalled because a Straight Condylar Plate is etched with a Curved Condylar Plate part number. Synthes USA HQ, Inc.
Devices Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral fractures Part # Lot # 04.001.620S 7115414 04.001.620S 7115417 04.001.620S 7115509 04.001.620S 7115510 04.001.622S 7115533 04.001.636S 7117902 04.001.636S 7117916 04.001.638S 7117924 04.001.640S 7119089 04.001.640S 7119107 04.001.642S 7117995 04.001.642S 7119125 04.001.644S 7117998 04.001.218S 7327816 04.001.444S 7379241 04.001.620s 7265517 Class II The packaging incorrectly depicts the Synthes Titanium Cannulated Humeral Nail as a 3 distal hole nail instead of a 2 distal locking hole nail. Synthes USA HQ, Inc.
Devices Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional is intended for fracture fixation (open and closed), pseudoarthrosis or non-unions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities and correction of segmental bony or soft tissue defects in adult and pediatric patients. all lots of model number 03.311.001: Part # Synthes lot # 03.311.001 1934765 03.311.001 1934766 03.311.001 1993844 03.311.001 3036688 03.311.001 3398576 03.311.001 3776484 03.311.001 5100597 03.311.001 5106354 03.311.001 5160872 03.311.001 5160875 03.311.001 5174253 03.311.001 5174253 03.311.001 5174254 03.311.001 5181000 03.311.001 5181001 03.311.001 5196282 03.311.001 5196283 03.311.001 5197081 03.311.001 5241942 03.311.001 5241943 03.311.001 5336723 03.311.001 5363637 03.311.001 5396016 03.311.001 5411479 03.311.001 5555521 Class II All lots of the Synthes Tensioning Device were recalled due to the potential for the reaction fork to come loose from the main body of the device and not allow the wire to release, nor the device to apply tension. Synthes USA HQ, Inc.
Devices Large Buttress Compression Nut For Blade Guide Sleeve TFN The Synthes Large Buttress Compression Nut For Blade Guide Sleeve TFN is intended to treat stable and unstable pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations there of. Part # Lot # SD357.371 5734551 6083065 6538811 6631975 6703191 6703190 6841538 Class II The Large Buttress Compression Nut For Blade Guide Sleeve TFN was recalled because of complaints that the compression nut did not thread completely onto the blade guide sleeve and became stuck. Synthes USA HQ, Inc.
Biologics Plasma Cryoprecipitated Reduced W120613077024 Class II Blood products, collected from a donor who was previously deferred, were distributed. Michigan Blood
Biologics Red Blood Cells Leukocytes Reduced W120613077024 Class II Blood products, collected from a donor who was previously deferred, were distributed. Michigan Blood
Biologics Cryoprecipitated AHF, Pooled W120613170169 Class II Blood products, collected from a donor who was previously deferred, were distributed. Michigan Blood
Biologics Platelets W140913337952 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. South Texas Blood & Tissue Center
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W051513079114 Class II Platelet, with insufficient plasma volume to support the platelet yield, was distributed. Innovative Blood Resources
Biologics Red Blood Cells Leukocytes Reduced W072013002391 Class II Blood products, collected from a donor who received a MMR vaccine, were distributed. Kaiser Foundation Hospital
Biologics Red Blood Cells Leukocytes Reduced W227713350465; Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Mid-South Regional Blood Center
Biologics Blood and Blood Products for Reprocessing W227713350465; Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Mid-South Regional Blood Center
Biologics Red Blood Cells Leukocytes Reduced W037712062073; W037712077244; Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Hoxworth Blood Center
Biologics Red Blood Cells Leukocytes Reduced W021513001895; Class II Blood product which was collected from a donor who was a resident of a malarial endemic area, was distributed. Dept Of The Navy, Naval Medical Center
Biologics Red Blood Cells Leukocytes Reduced W037712069574; W037712029845; Class II Blood products, which were collected from a donor who was a resident of a malarial endemic area, were distributed. Hoxworth Blood Center
Devices 3M ESPE, Unitek Stainless Steel Permanent Molar Crowns Stainless Steel Crowns, are designed to fill the need for long term provisional coverage on adult molars and bicuspids as well as pediatric posterior and anterior teeth. Product Code 902150 (Kit) · Lot Codes N484233 and N463186 Product Code 900224 (Refill) · Lot Codes N466509 and N473723 Class III 3M is recalling specific lots of 3M ESPE Unitek Primary Stainless Steel Crowns - Series UR4 contain LL3 crowns which are incorrectly labeled as UR4 crowns. 3M Company - Health Care Business
Drugs Alprazolam Orally Disintegrating Tablets, USP 2 mg, 100 count bottles, Rx Only, MFG. BY ACTAVIS ELIZABETH LLC., Elizabeth, NJ, NDC 0228-4025-11 Lot # 59380831, Exp. May 2014 Class II Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below specification in some tablets Actavis Elizabeth LLC
Devices Single Analyte Urine DAU Control (5 m L Norbuprenorphine, Level II control For In Vitro Diagnostic Use Only. store at 2 - 8 degrees C. Contents: Contains 13 mg/Ml of Norbuprenorphine in human urine with sodium azide as a preservative. Manufacturer: Lin-Zhi International, Inc. 670 Almanor Ave. Sunnyvale, CA 94085 The Norbuprenorphine Drug of Abuse (DUB) Positive control is used as assayed quality control material to monitor the precision of the Lin-Zhi International, Inc. Buprenorphine Enzyme immunoassay on the Synchron clinical analyzer. It in intended for the qualitative and semi-quantitative determination of norbuprenorphine in human urine. Catalog #A68825, Lot #1307086; Exp. 3/28/2014/ Class III Product catalog # A68825 Norbuprenorphine 13 ng/mL Level 2 Controls gives a decreased concentration reading due to the degradation of the NBUP analyte in solution. Lin-Zhi International Inc
Devices Synthes Material Mix (Adjustable Cervical Distractor-Right, Matrix Distractor Rack, T-PAL Spacer Remover, Implant Inserter) Synthes Material Mix: Adjustable Cervical Distractor-Right is used to distract spine segment. Matrix Distractor Rack is used to distract the interbody disc space. T-PAL Spacer Remover is used to remove T-PAL spacer. Implant Inserter is used to insert the ProDisc implant. part no. 396.396 (lot nos. T989765 and T989780), part no. 03.632.087 (lotT987270), part no. 03.812.005 (lot nos. T987734, T988931, and T987623), and part no. 03.820.129 (lot no. T988206). Class II One material batch used for production of the affected parts of the Synthes Material Mix were mixed in with an incorrect material with a lower than specified hardness and corrosion resistance. Synthes USA HQ, Inc.
Biologics Red Blood Cells Leukocytes Reduced 3510406 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Central California Blood Center
Biologics Blood and Blood Products for Reprocessing 3510406 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Central California Blood Center
Biologics Red Blood Cells Leukocytes Reduced W115913202325; W115913202324 Class III Blood products, collected using a machine for which daily quality control testing was not performed, were distributed. Central California Blood Center
Devices Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use. Product Code 17-001-56; Lot No. 27JY Class II Specific item numbers form Lots 27-J and 29-J of Sugita T2 Aneurysm Clips. Mini Temporary Type, are discolored. Mizuho America, Inc.
Devices Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary Mini Type No 58 Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use. Product Code 17-001-58; Lot No. 29JY Class II Specific item numbers form Lots 27-J and 29-J of Sugita T2 Aneurysm Clips. Mini Temporary Type, are discolored. Mizuho America, Inc.
Food Nutritional Frontiers Cyb Zyme- A Dietary Supplement for Complete Digestive Support 90 count Lot Number: 20165800 Class II Dietary supplements are recalled because they may contain trace amounts of the antibiotic chloramphenicol. The dietary supplements on recall contain enzymes that are on recall by Specialty Enzymes Biotechnology, a raw material supplier, because it contains chloramphenicol. FoodScience Corporation
Food Life Worth Living Nutriceuticals LWL Enzyme Life A Dietary Supplement for Complete Digestive Support, Distributed by Life Worth Living Nutriceuticals, 6488 Currin Drive, Orlando, Florida 32835 90 count Lot Number: 20525000 Class II Dietary supplements are recalled because they may contain trace amounts of the antibiotic chloramphenicol. The dietary supplements on recall contain enzymes that are on recall by Specialty Enzymes Biotechnology, a raw material supplier, because it contains chloramphenicol. FoodScience Corporation
Food Florayme A Dietary Supplement for Complete Digestive Support, 90 count capsules Distributed by Wendy Huang, MD, MPH, DABMA 9 Professional Circle, Suite 212, Colts Neck, NJ 07722 Lot Number: 20428800 Class II Dietary supplements are recalled because they may contain trace amounts of the antibiotic chloramphenicol. The dietary supplements on recall contain enzymes that are on recall by Specialty Enzymes Biotechnology, a raw material supplier, because it contains chloramphenicol. FoodScience Corporation
Food Cenk Disczyme A Dietary Supplement for Complete Digestive Support, 180 count capsule Distributed by Cenk Integrated Health & Spine Services, 107 Gamma Drive Ste 100, Pittsburgh, PA 15328 Lot Number: 20525100 Class II Dietary supplements are recalled because they may contain trace amounts of the antibiotic chloramphenicol. The dietary supplements on recall contain enzymes that are on recall by Specialty Enzymes Biotechnology, a raw material supplier, because it contains chloramphenicol. FoodScience Corporation
Devices Tri-Nex Healing Abutment, 0.50 mm x 5 mm height, Catalog No. HA-L-50-5. The NSI Implant System is intended to be implanted in the upper and lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Lot # 2676021303 Class II Southern Implants is recalling the Tri-Nex healing abutment because the package was incorrectly labeled and packaged as the Tri-Nex healing abutment, 05.0 mm x 5 mm height (HA-L-50-5). The package contains the Tri-Nex healing abutment 05.0 mm x 6.0 mm Flare x 5 mm Height (HA-L-50W-5). Southern Implants, Inc
Devices Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder for Synfix (TM)-LR is a non-powered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery all lots of part no. 03.802.039 Class II Complaints were received which described the SynFix LR implant holder breaking at the interface between the implant and the holder. Synthes USA HQ, Inc.
Devices Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to be used in ligament reattachment or fixation, specifically readaptation of torn or avulsed ligaments. part 219.951 with multiple lot#: 2335941 2339634 2397429 2405812 2440475 2442736 2496414 5661855 5663841 Class II During a retrospective assessment, Spiked Washers 13.5/6.5 were discovered to be mislabeled as Spiked Washers 13.5/5.5. Synthes USA HQ, Inc.
Devices Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar is used as part of the Synthes Tibial Nail System EX to stabilize fractures of the proximal and distal tibia and the tibia shaft, open and closed tibia shaft fractures, certain pre- and post- isthmic fractures, and tibial malunions and non-unions. part no. 03010.438S, lot 706802 Class II Complaints were received reporting that a product packaged as a 14.5 mm Outer Protection Sleeve for Suprapatellar contained a 12.0 mm Outer Protection Sleeve for Suprapatellar. Synthes USA HQ, Inc.
Devices ACCU-CHEK Aviva Combo Blood Glucose Meter (as a part of the ACCU-CHEK Aviva Combo System)\ The ACCU-CHEK Combo System is indicated for the treatment of insulin-requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood from the finger. AccuChek Aviva Combo meter 05075645005 packaged in Accu-Chek Combo Kit mg US/English version, 05458544001 and Accu-Chek Combo Kit mg US/Spanish version, 05504686001. Class II There is a software synchronization issue with the ACCU-CHEK Combo system. In rare cases, when the Manual Pump option is chosen on the ACCU-CHEK Aviva Combo meter, there is a possibility of receiving an incorrect bolus advice recommendation that may cause a temporary under delivery of insulin. Roche Diagnostics Operations, Inc.
Food Mozzarella String Cheese made with 2% milk for 1/4 less fat, sold under Kraft brand or Polly-O brand and packaged with either 12 or 24 pieces of mozzarella cheese individually wrapped in plastic and sold in a plastic bag with a net weight respectively of 10 oz. (283g) or 20 oz. (1 lb. 4 oz.) 566g. All product with the "Best When Used By" dates between 25 OCT 2013 - 11 FEB 2014. Class II Some varieties of Kraft and Polly-O String Cheese and String Cheese Twist products may spoil before their "Best When Used By" code dates, leading to product discoloration. The affected products all have code dates from October 25, 2013 through February 11, 2014. Kraft Foods Group
Food Low-Moisture Part-Skim Mozzarella String Cheese, sold under Kraft brand or Polly-O brand and packaged with either 12, 16, 24, or 48 pieces of mozzarella cheese individually wrapped in plastic and sold in a plastic bag with a net weight respectively of 12 oz. (340g), 16 oz. (1 lb.) (453 g), 24 oz. (1 lb. 8 oz.) (680g), or 48 oz. (3 lb.) (1.36 kg.). All product with the "Best When Used By" dates between 25 OCT 2013 - 11 FEB 2014. Class II Some varieties of Kraft and Polly-O String Cheese and String Cheese Twist products may spoil before their "Best When Used By" code dates, leading to product discoloration. The affected products all have code dates from October 25, 2013 through February 11, 2014. Kraft Foods Group
Food Low-Moisture Part-Skim Mozzarella String Cheese With Tomato and Basil, sold under Kraft brand or Polly-O brand and packaged with 12 pieces of mozzarella cheese with tomato and basil individually wrapped in plastic and sold in a plastic bag with a net weight of 10 oz. (283g). All product with the "Best When Used By" dates between 25 OCT 2013 - 11 FEB 2014. Class II Some varieties of Kraft and Polly-O String Cheese and String Cheese Twist products may spoil before their "Best When Used By" code dates, leading to product discoloration. The affected products all have code dates from October 25, 2013 through February 11, 2014. Kraft Foods Group
Food Low-Moisture Part-Skim Mozzarella String Cheese With Tomato and Italian Style Seasonings, sold under Kraft brand or Polly-O brand and packaged with 12 pieces of mozzarella cheese with tomato and Italian style seasoning individually wrapped in plastic and sold in a plastic bag with a net weight of 9 oz. (255g). All product with the "Best When Used By" dates between 25 OCT 2013 - 11 FEB 2014. Class II Some varieties of Kraft and Polly-O String Cheese and String Cheese Twist products may spoil before their "Best When Used By" code dates, leading to product discoloration. The affected products all have code dates from October 25, 2013 through February 11, 2014. Kraft Foods Group
Food Low-Moisture Part-Skim Mozzarella String Cheese With Jalapeno Peppers, sold under Kraft brand or Polly-O brand and packaged with 12 pieces of mozzarella cheese with jalapeno peppers individually wrapped in plastic and sold in a plastic bag with a net weight of 10 oz. (283g). All product with the "Best When Used By" dates between 25 OCT 2013 - 11 FEB 2014. Class II Some varieties of Kraft and Polly-O String Cheese and String Cheese Twist products may spoil before their "Best When Used By" code dates, leading to product discoloration. The affected products all have code dates from October 25, 2013 through February 11, 2014. Kraft Foods Group
Food Low-Moisture Part-Skim Mozzarella String Cheese With Cracked Pepper, sold under Kraft brand or Polly-O brand and packaged with 12 pieces of mozzarella cheese with cracked pepper individually wrapped in plastic and sold in a plastic bag with a net weight of 10 oz. (283g). All product with the "Best When Used By" dates between 25 OCT 2013 - 11 FEB 2014. Class II Some varieties of Kraft and Polly-O String Cheese and String Cheese Twist products may spoil before their "Best When Used By" code dates, leading to product discoloration. The affected products all have code dates from October 25, 2013 through February 11, 2014. Kraft Foods Group
Food Low-Moisture Part-Skim Mozzarella String Cheese With Barbecue Seasoning, sold under Kraft brand or Polly-O brand and packaged with 12 pieces of mozzarella cheese with barbecue seasoning individually wrapped in plastic and sold in a plastic bag with a net weight of 9 oz. (255g). All product with the "Best When Used By" dates between 25 OCT 2013 - 11 FEB 2014. Class II Some varieties of Kraft and Polly-O String Cheese and String Cheese Twist products may spoil before their "Best When Used By" code dates, leading to product discoloration. The affected products all have code dates from October 25, 2013 through February 11, 2014. Kraft Foods Group
Food Low-Moisture Part-Skim Mozzarella String Cheese With Jalapeno Peppers, sold under Kraft brand and packaged with 24 pieces of mozzarella cheese with jalapeno peppers individually wrapped in plastic and sold in a cardstock display box bag with a net weight of 24 oz. (1 lb. 8 oz.) (283g). All product with the "Best When Used By" dates between 25 OCT 2013 - 11 FEB 2014. Class II Some varieties of Kraft and Polly-O String Cheese and String Cheese Twist products may spoil before their "Best When Used By" code dates, leading to product discoloration. The affected products all have code dates from October 25, 2013 through February 11, 2014. Kraft Foods Group
Devices Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Spine, Parsippany, NJ 07054 The Polaris Spinal Systems is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedical screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterior or anterolateral fixation system. Pedicle screw fixation is limited to skeletal mature patients for use with autograft and/or allograft. The device is indicated for all the following indications:degenerative disc disease (defined as discogeneic back pain with degeneration of the disk confirmed by history and radiographic studies), spondylolisthesis, and or lordosis) tumor, stenosis, pseudoarthrosis, or failed previous fusion Device listing # D090878 Catalog # LV00407 Lot #184090 Class II Biomet received a complaint on 5/20/2013 reporting that the tip of the instrument sheared off during a removal case. Ebi, Llc
Devices Product Brand Name(s): Alere Cholestech LDX® Lipid Profile"GLU Test Cassette, Model 10-991. Product Generic Name: Alere Cholestech LDX® Lipid Profile"GLU Test Cassette. Description of the product: Lipid. Glucose panel Test cassettes. Product packaging: 10 individually pouched cassettes in a labeled kit box. Intended for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, triglycerides, and/or glucose in whole blood, serum, and plasma. Model Number: 10-991. Lot #320167. Expiration date, or Expected shelf life: 8/31/14. Expected shelf life: up to 12 months. Class III Alere initiated a recall of Cholestech LDX Lipid Profile-GLU test cassettes, Catalog Number 10-991, Lot # 320167, becuase an incorrect lot number was printed on the outer 10 pack kit box label. The incorrect Lot # number printed was 321067. Alere San Diego, Inc.
Devices 3.7mm and 5.0mm Dynamic Locking Screw (DLS) Product Usage: 3.7mm and 5.0mm Dynamic Locking Screw (DLS) in combination with Synthes Locking Compression Plates (LCP) are intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions. All lots of parts 09.213.022S - 09.213.070S, and 09.223.032S- 09.223.090S. Class II All lots of 3.7mm and 5.0mm Dynamic Locking Screw (DLS) were recalled due to complaints of breakages at the distal tip of the pin identified after successful healing and during planned removal of the device. Synthes USA HQ, Inc.
Food ParaZYME, 90 capsules per bottle, is dietary supplement and sold under Renew Life brand. The UPC Code 6 31257 30990 7. The product is labeled in parts: "***PARAZYME***renew LIFE***The Digestive Care Company***90 Vegetable Capsules***Distributed by: ReNew Life Formulas***Palm Harbor, FL 34683***www.renewlife.com***1-800-830-1800***". ParaZYME Lot: 57515, 57766, 58607, and 59505. Class II Dietary supplement product was made from ingredients that are contaminated with Chloramphenicol. Pacific Nutritionals
Food -Superior Digestion, 60 capsules per bottle, is dietary supplement and sold under Purelife Naturals brand. The UPC Code 6 31257 17509 0. -Superior Digestion, Dietary Supplement, Bulk Case, NO UPC. The retail 60 count bottle is labeled in parts: "***Superior Digestion***purelife NATURALS***60 PURE-CAPS***Distributed by PureLife Naturals***Clearwater, FL 33765***www.purelife-naturals.com***1-800-220-7986***". -Superior Digestion 60 counts bottle Lot numbers: 57518, 58183, 58185, and 58969. -Superior Digestion Bulk Lot number: 58066. Class II Dietary supplement products were made from ingredients that are contaminated with Chloramphenicol. Pacific Nutritionals
Food -DigestMORE, 90 capsules per bottle, Food Supplement is sold under Renew Life brand. The UPC Code 6 31257 35000 8. -DigestMORE Ultra, 60 capsules per bottle, Food Supplement is sold under Renew Life brand. The UPC Code 6 31257 35001 5. The DigestMORE product is labeled in parts: "***DigestMORE***RENEW LIFE***The Digestive Care Company***90 Capsules***Food Supplement***RENEW LIFE UK***Unit 3, 12 Commercial Road, Reading, Berkshire***RG2 0QJ***www.renewlife.co.uk***. The DigestMORE Ultra product is labeled in parts: "***DigestMORE Ultra***RENEW LIFE***The Digestive Care Company***60 Capsules***Food Supplement***RENEW LIFE UK***Unit 3, 12 Commercial Road, Reading, Berkshire***RG2 0QJ***www.renewlife.co.uk***. -DigestMORE (90 capsules) lot number: 59344. -DigestMORE Ultra (60 capsules) lot number: 59343. Class II Food supplement products were made from ingredients that are contaminated with Chloramphenicol. Pacific Nutritionals
Food Mixed Seed Brittle ("Pepitoria Mixed"), in cellophane packages, Net Wt. 2oz (57g), UPC 6 61444 00017 1. Las Trojes lot codes: 03092014, 03162014. El SuperLeon Ponchin Snack lot code: 03162014. Happy Snacks Lot codes: 03092014. Class II Las Trojes is recalling Las Trojes brittle snack foods because they may contain undeclared soy lecithin. Las Trojes
Food Sesame Seed Brittle ("Pepitoria De Ajonjoli"), in cellophane packages, Net Wt. 2 oz (57g), UPC 6 61444 00006 5. Las Trojes Lot Codes: 03092014, 03162014. El SuperLeon Ponchin Lot Codes: 03162014. Happy Snacks (Seyma Products) lot codes: 03092014. Class II Las Trojes is recalling Las Trojes brittle snack foods because they may contain undeclared soy lecithin. Las Trojes
Food Coconut Brittle ("Pepitoria De Coco"), in cellophane packages, Net Wt. 2 oz (57g), UPC 6 61444 00013 3. Las Trojes Lot Codes: 03092014, 03162014. El SuperLeon Ponchin Lot Codes: 03162014. Happy Snacks (Seyma Products) lot codes: 03092014. Class II Las Trojes is recalling Las Trojes brittle snack foods because they may contain undeclared soy lecithin. Las Trojes
Food Pumpkin Seed Brittle ("Pepitoria"), in cellophane packages, Net Wt. 2 oz (57g), UPC 6 61444 0000 5 8. Las Trojes Lot Codes: 03092014, 03162014. El SuperLeon Ponchin Lot Codes: 03162014. Happy Snacks (Seyma Products) lot codes: 03092014. Class II Las Trojes is recalling Las Trojes brittle snack foods because they may contain undeclared soy lecithin. Las Trojes
Food Peanut Brittle ("Pepitoria De Cacahuate"), in cellophane packages, Net Wt. 2 oz (57g), UPC 6 61444 00012 6. Las Trojes Lot Codes: 03092014, 03162014. El SuperLeon Ponchin Lot Codes: 03162014. Happy Snacks (Seyma Products) lot codes: 03092014. Class II Las Trojes is recalling Las Trojes brittle snack foods because they may contain undeclared soy lecithin. Las Trojes
Devices Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER is used for buttressing multi fragmentary diatal femur fractures including: supra-condylar, intra-articular and extra articular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, nonunions and malunions. part 04.124.406S, lot 3771678. Class II A plate was inadvertently released to a sales consultant that was restricted for sale. Synthes USA HQ, Inc.
Devices MAS Urinalysis Control Level 1, Multi-analyte control (Assayed and Unassayed), Catalog/Part Numbers: 024222; Product is manufactured and distributed by Microgenics Corporation, a subsidiary of Thermo Fisher Scientific, Clinical Diagnostic Division, Fremont, CA MAS Urinalysis is intended for use in the clinical laboratory as a control for qualitative and semi-quantitative procedures used in routine urinalysis testing. Assay values are provided for specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and equipment. The product is suitable for use as a control material for physiochemical, chemical, and microscopic methods of routine urinalysis. Urinalysis may be used in conjunction with commercially available standardized systems for urine microscopic analysis. Lot Number: UA1514011 Class III Via one (1) consumer complaint and in-house testing has confirmed that the product does not meet the 30 day open vial stability specifications for Lot: UA1514011. Thermofisher Scientive
Devices Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Product Usage: The V Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use for the V Series include the monitoring of the following human physiological parameters: 1) ECG waveform derived from 3, 5, 6 and 12 lead measurements 2) Heart Rate 3) Pulse Oximtery 4) ST Segment 5) Arrhythmia Detection 6) Non Invasive Blood Pressure (IBP) 7) Cardiac Output (CO) 8) Respiratory Gases 9) Respiration Rate 10) Temperature The V series monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices. V Series Montor p/n 0998-00-1801-01 and the associated V Dock , p/n 0998-UC-180-01 Class II Mindray has identified an issue with V Series Monitor where the V Dock power pins connecting the V Series Monitor to the V Dock may lose spring tension, potentially causing the screen to temporarily go blank, lose communication with the central station monitor (when one is in use) or shut down. No patient related events have been reported to Mindray concerning the issue. Mindray DS USA, Inc. dba Mindray North America
Devices REF 200068 Security (TM) Enclosed Carpal Tunnel System Blade ( Single) ABS /Stainless Steel Sterile Device, Single Use Only. Designed to release the transverse carpal ligament. Catalog Number: 200068 Medical Device Listing Number: B008657 Lot Number Identification: 088610, 090600, 143810, 257060, 289900, 365910, 460490, 558300, 626660, 697320,767260,795090,857730,864640,979680 Class II Security Blades were manufactured oversized and potentially won't advance or may be difficult to advance through the mating Security Clip. Biomet, Inc.
Food Plum Organics Broccoli & Apple Organic Baby Food, 4 oz. pouch; Flexible pouch with Re-sealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM Item number 866 Selling Unit UPC: 846675000538; Case UPC:846675000866; Item number 80016; Selling Unit UPC: 846675000538 Case UPC 846675003935 Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. Class II Manufacturing defect leading to post-process contamination. Plum Inc
Food Plum Organics Peach, Apricot & Banana Organic Baby Food, 4 oz. pouch. Flexible pouch with resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM Item number 873 Selling Unit UPC: 890180001214; Case UPC: 846675000873 Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. Class II Manufacturing defect leading to post-process contamination. Plum Inc
Food Plum Organics Sweet Potato, Mango & Millet Organic Baby Food; 3.5 oz. Pouch; Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM Item number 1214: Selling Unit UPC: 846675001047; Case UPC: 846675001214; Item 80020: Selling Unit UPC: 846675001047; Case UPC:846675001214 Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. Class II Manufacturing defect leading to post-process contamination. Plum Inc
Food Plum Organics Apple Raisin & Quinona Organic Baby Food; 3.5 oz. Pouch; Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM Item number1221: Selling Unit UPC: 846675001054; Case UPC: 846675001221; Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. Class II Manufacturing defect leading to post-process contamination. Plum Inc
Food Plum Organics Zucchini, Banana & Amaranth Organic Baby Food; 3.5 oz. Pouch; Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM Item number 1238: Selling Unit UPC: 846675001061; Case UPC: 846675001238 Item number 80021; Selling Unit UPC: 846675001061; Case UPC: 846675003966 Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. Class II Manufacturing defect leading to post-process contamination. Plum Inc
Food Plum Organics Plum, Berry & Barley Organic Baby Food; 3.5 oz. Pouch; Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM Item number 1245: Selling Unit UPC: 846675001078 ; Case UPC: 846675001245 Item number: 80019; Selling Unit UPC: 846675001078 ; Case UPC: 846675003980 Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. Class II Manufacturing defect leading to post-process contamination. Plum Inc
Food Plum Organics Tots Purple Roots and Fruits Yogurt Mish Mash; 3.17 oz. Pouch; Also 12.69 oz. box. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM Item number 1269 - pouch Selling Unit UPC: 846675000996 ; Case UPC: 846675001269; Item number: 1528 - box; Selling unit UPC: 846675001467; Case UPC: 846675001528. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. Class II Manufacturing defect leading to post-process contamination. Plum Inc
Food Plum Organics Tots Berry, Banana, Beet Yogurt Mish Mash; 3.17 oz. Pouch; also in 12.69 oz. box. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM Item number 1276: pouch Selling Unit UPC: 846675001009 ; Case UPC:846675001276 ; Item number: 1511 - box Selling Units UPC:846675001450 ; Case UPC: 846675001511 Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. Class II Manufacturing defect leading to post-process contamination. Plum Inc
Food Plum Organics Cherry & Sweet Corn Organic Baby Food, 4 oz. pouch. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM Item number 1382: Selling Unit UPC: 846675001344 ; Case UPC:846675001382 ; Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. Class II Manufacturing defect leading to post-process contamination. Plum Inc
Food Plum Organics Green Bean, Pear & Greek Yogurt Organic Baby Food, 4 oz. pouch. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM Item number 1399: Selling Unit UPC:846675001337; Case UPC:846675001399 ; Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. Class II Manufacturing defect leading to post-process contamination. Plum Inc
Food Plum Organics Raspberry, Spinach & Greek Yogurt Organic Baby Food, 4 oz. pouch. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM Item number 1405: Selling Unit UPC:846675001320; Case UPC846675001405; Item number: 80024; Selling Unit UPC:846675001320 Case UPC: 846675004000 UK Export only Item number RSG18U Sellling unit UPC: 5060116891591 Case UPC: 5060116897746 Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. Class II Manufacturing defect leading to post-process contamination. Plum Inc
Food Plum Organics Tots Blueberry Oats & Quinoa Morning Mish Mash - 12.79 oz. box. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM Item number 1498: Selling Unit UPC:846675001436; Case UPC:846675001498. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. Class II Manufacturing defect leading to post-process contamination. Plum Inc
Food Plum Organics Spinach, Peas & Pear Organic Baby Food, 4 oz. pouch.. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM Item number 1566: Selling Unit UPC:890180001191; Case UPC:890180001566. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. Class II Manufacturing defect leading to post-process contamination. Plum Inc
Food Plum Organics Sweet Potato, Corn & Apple Organic Baby Food- 4 oz. Pouch Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM Item number 11573: Selling Unit UPC; 890180001245 Case UPC: 890180001573 Item number 80013; Selling Unit UPC; 890180001245 Case UPC;846675003492 Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. Class II Manufacturing defect leading to post-process contamination. Plum Inc
Food Plum Organics Blueberry, Pear and Purple Carrot Organic Baby Food, 4 oz. pouch.. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM Item number 1580: Selling Unit UPC:890180001979 Case UPC: 890180001580 Item number 80015: Selling Unit UPC:890180001979 Case UPC: 846675003928 Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. Class II Manufacturing defect leading to post-process contamination. Plum Inc
Food Plum Organics Pumpkin & Banana Organic Baby Food, 3.5 oz. pouch.. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM Item number 1597: Selling Unit UPC:890180001238; Case UPC: 890180001597; Item number: 80017: Selling Unit UPC: 890180001238 Case UPC: 846675003959 Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. Class II Manufacturing defect leading to post-process contamination. Plum Inc
Food Plum Organics Pear and Mango Organic Baby Food, 4.0 oz. pouch.. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM Item number 1610: Selling Unit UPC:890180001207; Case UPC: 890180001610. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. Class II Manufacturing defect leading to post-process contamination. Plum Inc
Food Plum Organics Apple & Carrot Organic Baby Food, 4.0 oz. pouch.. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM Item number 1634: Selling Unit UPC:890180001221; Case UPC:890180001634. Item 80018; Selling Unit UPC:890180001221; Case UPC: 890180003997 Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. Class II Manufacturing defect leading to post-process contamination. Plum Inc
Food Plum Kids Beetbox Berry Fruit and Veggie Mashups, 12.69 oz. box. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM Item number 1849: Selling Unit UPC; 846675001658 Case UPC:846675001849. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. Class II Manufacturing defect leading to post-process contamination. Plum Inc
Food Plum Kids Blueberry Blitz Fruit & Veggie Mashups, 12.69 oz. box. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM Item number 1856: Selling Unit UPC; 846675001665 Case UPC:846675001856. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. Class II Manufacturing defect leading to post-process contamination. Plum Inc
Food Plum Kids Tropical Fruit Mashups, 12.69 oz. box. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM Item number 1894: Selling Unit UPC; 846675001818 Case UPC:846675001894. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. Class II Manufacturing defect leading to post-process contamination. Plum Inc
Food Plum Kids Mixed Berry Mashups, 10 ct. Club Pack. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM Item number 2839: Selling Unit UPC; 846675002839 Case UPC: NA. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. Class II Manufacturing defect leading to post-process contamination. Plum Inc
Food Plum Organics Blueberry, Parsnip & Buckwheat Organic Baby Food- 3.5 oz. Pouch . Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM Item number 80006: Selling Unit UPC; 846675003782 Case UPC:00846675003867 . Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. Class II Manufacturing defect leading to post-process contamination. Plum Inc
Food Plum Organics Pumpkin, Dates, Oats & Chia Organic Baby Food- 3.5 oz. Pouch Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM Item number 80007: Selling Unit UPC; 846675003775 Case UPC:00846675003850 Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. Class II Manufacturing defect leading to post-process contamination. Plum Inc
Food Plum Organics Kale, Apple & Greek Yogurt Organics Baby Food- 3.5 oz. Pouch Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM Item number 80008: Selling Unit UPC; 846675003768 Case UPC:00846675003843 Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. Class II Manufacturing defect leading to post-process contamination. Plum Inc
Food Plum Organics Mango, Carrot & Greek Yogurt Organics Baby Food- 3.5 oz. Pouch Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM Item number 80009; Selling Unit UPC; 846675003751 Case UPC:00846675003836 UK Export only: Item number MCG18U: Selling Unit UPC5060116891607: Case UPC:5060116897753 Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. Class II Manufacturing defect leading to post-process contamination. Plum Inc
Food Parsnip, Blueberry & Buckwheat Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM UK Export only Item number PBW11U; Selling Unit UPC; 5060116891676 Case UPC:5060116897821 Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. Class II Manufacturing defect leading to post-process contamination. Plum Inc
Food Plum, Strawberry Barley Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM UK Export only Item number PBB11U; Selling Unit UPC; 5060116891638 Case UPC:5060116897784 Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. Class II Manufacturing defect leading to post-process contamination. Plum Inc
Food Courgette Banana & Amaranth Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM UK Export only Item number CBA11U; Selling Unit UPC; 5060116891638 Case UPC:5060116897784 Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. Class II Manufacturing defect leading to post-process contamination. Plum Inc
Food Kale, Apple & Greekstyle Yogurt Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM UK Export only Item number KAG11U; Selling Unit UPC; 5060116891621 Case UPC:5060116897777 Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. Class II Manufacturing defect leading to post-process contamination. Plum Inc
Drugs Acyclovir Tablets USP 800 mg ,(NDC 60505-5307-1), Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for Apotex Corp.,Weston, Florida 33326. Lot # KF2199 Exp 07/15 Class II Presence of Particulate Matter: Product from lot KF2199, may contain tablets with pieces of nitrile rubber glove embedded within the tablets. Apotex Inc.
Drugs PACLITAXEL INJECTION, USP (semisynthetic); 300 mg/50 mL; (6 mg/mL); Multiple Dose Vial;(NDC 63323-763-50); Rx Only; Manufactured for APP Pharmaceuticals, LLC; Schaumburg, IL 60173; Made in India Lot # 871ZA00201, Exp 11/13 Lot # 871ZA00301, Exp 11/13 Lot # 871ZA00302, Exp 11/13 Lot # 871ZA00401, Exp 11/13 Lot # 871ZA00402, Exp 11/13 Lot # 872ZA00101, Exp 12/13 Lot # 872ZA00201, Exp 12/13 Lot # 872ZA00301, Exp 12/13 Lot # 872ZA00401, Exp 12/13 Lot # 872ZA00501, Exp 12/13 Class III Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" and "Specific Adverse Events" sections. Fresenius Kabi USA, LLC
Devices STERRAD 100NX, Product Code: 10104 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. Please refer to consignee list Class II Advanced Sterilization Products (ASP) is recalling the STERRAD NX and STERRAD 100NX sterilization systems because ASP has determined that the bronchoscopes may contain a polyurethane material in the suction channel location that is not listed in the current claims for interior channels (lumens) for processing in STERRAD systems. Advanced Sterilization Products
Devices STERRAD NX, Product Code: 10033 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. Please refer to consignee list Class II Advanced Sterilization Products (ASP) is recalling the STERRAD NX and STERRAD 100NX sterilization systems because ASP has determined that the bronchoscopes may contain a polyurethane material in the suction channel location that is not listed in the current claims for interior channels (lumens) for processing in STERRAD systems. Advanced Sterilization Products
Food Ortho Molecular Products DigestzymeV. Dietary Supplement. Gastrointestinal health. 90 (product code 128090 and 128090U) and 180 capsules (product code 128180 and 128180U). Lot numbers beginning with: 73639, 73771, 73961, 74127, 74232, 74307, 74464, 74575, 74753, 74895, 75046, 75172 Class II Ortho Molecular Products' vegetable enzyme vendor issued a recall of the raw material due to potential chloramphenicol contamination. Ortho Molecular Products Inc
Food TriEnza bulk powder distributed in a 5 kilogram polyethylene bag. Lot # 83381000 Class II The firm is recalling a dietary supplement containing a raw material which may contain >0.3 ppb of chloramphenicol. Houston Nutraceuticals, Inc
Devices LANX Timberline MPF Lateral Modular Plate Fixation System Straight Split Tip Driver - Short ("Driver"). Model Number 8630-0107. The Timberline MPF device is an intervertebral body fusion device consisting of a PEEK intervertebral spacer, titanium plate, and screws. The PEEK spacer has a generally rounded shape with various heights and footprints and has a hollowed out central area to accommodate autogenous bone graft. The upper and lower surfaces have a series of transverse grooves formed to improve stability and fixation once the device is inserted. The titanium plate has holes for receiving bone screws and a central hole for receiving a cover plate to prevent screw back-out. The Timberline MPF system is available in a variety of sizes and configurations to approximate anatomical variation in different vertebral levels and/or patient anatomy. The Timberline MPF system is provided nonsterile. The Driver is used with the Timberline MPF system to drive titanium screws through the plate and into the vertebrae thus locking plate to the vertebrae. Lot No: TU00090, TU00157 and TU00242 Class II Lanx, Inc. is recalling various lots of Timberline MPF Straight Split Tip Driver - Short ("Driver") because the width of the most distal end from the Driver handle (the tip of the hex portion of the Driver) is oversized. Lanx, Inc.
Food Gluten Free 60 vcaps, sku#609492310194. 12 units per shipping carton/case. Lot Numbers: 120950, 130211, 130411, and 130763. Class II Metabolic Response Modifier (MRM) is recalling Gluten Free 60 vcaps because it may contain trace amounts of the antibiotic, chloramphenicol. Mrm
Food Digestive Enzymes, Digestion, 4Life, Dietary Supplement, 90 Capsules, A Product of 4Life Manufactured by BioMedical Research Laboratories, LLC, Sandy, UT, Item #23017. Lot No: 12020023, 12060043, 12080147, 12090208, 13060177, and 13080062. Class II 4Life Research, LLC is voluntarily recalling various lots of Digestive Enzymes product due to the presence of trace amounts of the antibiotic, chloramphenicol. 4Life Research, LLC
Devices SIGMA® LCS® HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED SIZE 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty. Item #950502010 Class II DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient. DePuy Orthopaedics, Inc.
Devices SIGMA® LCS® HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty Item #950502011 Class II DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient. DePuy Orthopaedics, Inc.
Devices SIGMA® LCS® HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty. Item #950502012 Class II DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient. DePuy Orthopaedics, Inc.
Devices SIGMA® LCS® HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty. Item #950502013 Class II DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient. DePuy Orthopaedics, Inc.
Devices SIGMA® LCS® HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty. Item #950502014 Class II DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient. DePuy Orthopaedics, Inc.
Devices SIGMA® LCS® HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty. Item #950502015 Class II DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient. DePuy Orthopaedics, Inc.
Devices SIGMA® LCS® HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty. Item #950502016 Class II DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient. DePuy Orthopaedics, Inc.
Devices SIGMA® LCS® HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty. Item #950502017 Class II DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient. DePuy Orthopaedics, Inc.
Devices SIGMA® LCS® HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty. Item #950502018 Class II DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient. DePuy Orthopaedics, Inc.
Devices SIGMA® LCS® HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty. Item #950502019 Class II DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient. DePuy Orthopaedics, Inc.
Devices SIGMA® LCS® HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty. Item #950502020 Class II DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient. DePuy Orthopaedics, Inc.
Devices SIGMA® LCS® HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty. Item #950502021 Class II DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient. DePuy Orthopaedics, Inc.
Devices CSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022; CSF-Unitized Shunt, Contoured Regular, Medium Pressure, Catalog No. 46024; CSF-Unitized Shunt, Contoured Regular, High Pressure, Catalog No. 46026. CSF-Unitized Shunt Kits are designed as integrated CSF-Flow Control Shunts for use in shunting cerebrospinal fluid from the lateral ventricle of the brain into the peritoneal cavity. Lot Numbers: Catalog No. 46022: D27162; D30984; D3461 0; D35834; D37761; D39054; D39539. Catalog No. 46024: D13944; D14093; D14217; D14216; D33526; D39540. Catalog No. 46026: D35572; D39583. Class II Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the Strata II Shunt Assembly Kit because they were found to have label discrepancies. Medtronic Neurosurgery
Devices Medtronic Delta Shunt Assembly Kit with Bioglide Small, Performance Level 1.0, Catalog No. 276201. Delta Shunt Assemblies are designed for use in shunting CSF from the lateral ventricle of the brain into the peritoneal cavity. Lot Numbers: D01859; D11969; D15985; D25462; D37523; D42401. Class II Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the Strata II Shunt Assembly Kit because they were found to have label discrepancies. Medtronic Neurosurgery
Devices Medtronic Strata II Shunt Assembly Kit, Small, Catalog No. 27848. Strata II Shunt Assemblies are designed to provide continued cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart of the peritoneal cavity. Lot Numbers: D22311; D37565. Class II Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the Strata II Shunt Assembly Kit because they were found to have label discrepancies. Medtronic Neurosurgery
Food PCC, Rebecca's Natural Food, Sprouts Famous Market, Ritzman Pharmacy, Earth Fare, Hartig Drug, Viroqua Food, Ramona Fitness Center, Independent Choice (Health Trail Natural Foods-The Crunchy Grocer), Jimbo's, Outpost Natural Foods BRANDS- Woman's Once Daily Tablets - A dietary Supplement,Product Code Multivitamin/Mineral with Green Foods, Herbs, Enzymes & Probiotics Dietary Supplement. 90 Vegetarian Tablets. Manufactured for PCC Natural Markets Seattle, WA 98105 Lot No.: 416035 Class II Nexgen Pharma Inc. is recalling one lot of Woman's Once Daily vitamin because it was contaminated with the antibiotic, Chloramphenicol. Nexgen Pharma, Inc.
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