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U.S. Department of Health and Human Services

Enforcement Report - Week of January 30, 2013

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Red Blood Cells Leukocytes Reduced 020GH34105, 020GH30554, 020GH29543, 020GH32968, 020GH31503. Class II Blood products, collected from an ineligible donor, were distributed. American National Red Cross (The)
Biologics Blood and Blood Products for Reprocessing 020GH34105, 020GH31503, 020GH30554, 020GH26857, 020GH25072, 020GH22247, 020GH21136. Class II Blood products, collected from an ineligible donor, were distributed. American National Red Cross (The)
Biologics Plasma Frozen 020GH32968. Class II Blood products, collected from an ineligible donor, were distributed. American National Red Cross (The)
Biologics Platelets Pheresis Leukocytes Reduced 09LY02616(Part A) ;09LY02616(Part B) Class II Blood products, with unacceptable, undocumented or incomplete product QC and platelet counts were distributed. American National Red Cross (The)
Biologics Source Plasma 01200637010; 01200470088; 01200176954; 01200174238; 01200166481; 01200163985; 01200156646; 01200153947; 01200147109; 01200143335; 01200137410; 01200134527; 01200127087; 01200125153; 01200117030; 01200114577; 01200105400; 01200102197; 01200094140 Class II Blood products, collected from donor's who did not have a complete physical examination, were distributed. CSL Plasma Inc
Biologics Sipuleucel-T 3044411 Class III Provenge (sipuleucel-T), with an out-of-specification (OOS) assay result, was distributed. Dendreon Corporation
Drugs Major Oral Peroxide (Carbamide Peroxide 10%), 2 fl oz (60 mL), Distributed by: Major Pharmaceuticals 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-4062-03 Lot #s L11065, exp 12/2013; B12019, exp 2/2014; B12020, exp 2/2014; and D12035, exp 4/2014. Class III Stability data does not support expiration date: Stability data indicates the Carbamide Peroxide will degrade below acceptable levels within the 24-month expiration date printed on the packaging. Axcentria Pharmaceuticals LLC
Drugs Trastuzumab Kit containing 1 vial Trastuzumab (nominal content: 440 mg); 1 20 mL multiple dose vial Bacteriostatic Water for Injection, USP (1.1% benzyl alcohol), Manufactured by Hospira, Inc., for Genentech, Inc., South San Francisco, CA 94080-4990, NDC 50242-903-69; and 1 Reconstitution Instructions per kit; Investigation Use only, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080-4990. Lot #: 454138, Exp 07/14 (containing Trastuzumab Lot #: 886618, Exp 12/14; and Bacteriostatic Water for Injection, USP Lot #: 08-368-DK-01, Exp 07/14) Class I Presence of Particulate Matter: One lot of Bacteriostatic Water for Injection, USP diluent vials that were packed with Trastuzumab Kits for investigational use has the potential to contain glass particulates. Genentech Inc
Biologics Red Blood Cells Leukocytes Reduced Irradiated 24GV54136; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. American National Red Cross
Biologics Plasma Frozen within 24 hours (FP24) 24GV54136; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. American National Red Cross
Biologics Red Blood Cells Leukocytes Reduced W137512105781; Class II Blood product, which was collected from a donor who traveled to malarial endemic areas, was distributed. Lane Memorial Blood Bank
Biologics Red Blood Cells 1501084; Class II Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells 2782441; 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 2782441; 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 2939678; 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 W088412540032; Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. Blood Bank Of Hawaii
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W227012026550; Class II Blood product, which was not tested to verify the pH and White Blood Cell count, was distributed. Community Blood Center of Carolinas
Biologics Source Plasma 12HIDD6894; 12HIDD6268; 12HIDD4985; 12HIDD4469; 12HIDD3145; 12HIDD2431; 12HIDD1162; 12HIDD0429; 12HIDC9138; 12HIDC8510; Class II Blood products, collected from a donor who did not have a complete physical examination, were distributed. BioLife Plasma Services, L.P.
Biologics Plasma Frozen within 24 hours (FP24) W045110186446; W045110138504; Class II Blood products, collected from a donor who was in close contact with an individual diagnosed with Hepatitis B, were distributed. Community Blood Center of the Ozarks
Biologics Red Blood Cells W045110138504; Class II Blood products, collected from a donor who was in close contact with an individual diagnosed with Hepatitis B, were distributed. Community Blood Center of the Ozarks
Biologics Red Blood Cells Leukocytes Reduced W045112343677; W045111224055; W045110188169; W045110186446; Class II Blood products, collected from a donor who was in close contact with an individual diagnosed with Hepatitis B, were distributed. Community Blood Center of the Ozarks
Biologics Blood and Blood Products for Reprocessing W045112343677; W045111224055; W045110188169; Class II Blood products, collected from a donor who was in close contact with an individual diagnosed with Hepatitis B, were distributed. Community Blood Center of the Ozarks
Biologics Red Blood Cells Leukocytes Reduced W043212004915; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Blood Assurance Inc
Biologics Blood and Blood Products for Reprocessing W043212004915; Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Blood Assurance Inc
Biologics Source Plasma 12HIDC6420; Class II Blood product, collected from a donor who did not have a complete physical examination, was distributed. BioLife Plasma Services, L.P.
Biologics Platelets Pheresis Leukocytes Reduced Irradiated 22FL28810PART1; 22FL28810PART2; 22FL28699PART2; Class II Blood products, collected using equipment that had not been validated, were distributed. American National Red Cross, Penn-Jersey Region
Biologics Platelets Pheresis Leukocytes Reduced 22FL28725PART1; 22FL28725PART2; 22FL28699PART1; 22FL28679PART1; Class II Blood products, collected using equipment that had not been validated, were distributed. American National Red Cross, Penn-Jersey Region
Biologics Red Blood Cells Leukocytes Reduced W043212025175; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Blood Assurance Inc
Biologics Blood and Blood Products for Reprocessing W043212025175; Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Blood Assurance Inc
Devices Roche COBAS INTEGRA 400 and 400 plus Analyzer The Roche COBAS INTEGRA 400/400 plus Analyzer is a fully automated system for clinical chemistry analysis intended for the in vitro quantitative/qualitative determination of analytes in body fluids. Part Numbers:28065047001 and 03245233001 Class III A software security issue with Oracles TNS-Listener component has been identified. TNS-Listener is supplied with the Roche COBAS INTEGRA 400/400 plus Analyzers. The Oracle TNS-Listener can be considered as an authentication and redirection component between the client and the database inside the Roche product. This means an attacker could register their own non-Roche database via remote access over the network to the Roche product and read and write database queries without authentication and therefore modify the content of a database. Roche Diagnostics Operations, Inc.
Biologics Plasma Frozen within 24 hours (FP24) 02K71938 Class III Blood products, which were labeled with an incorrect volume, was distributed. American National Red Cross SW Region - HT
Devices DePuy Spine VIPER POLY SCREW 5.5 8 X70MM Tl Product Code: 1867-15-870 Spinal Implant Component. All lots Class II Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER® large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head DePuy Spine, Inc.
Devices DePuy Spine VIPER POLY SCREW 5.5 8 X80MM Tl Product Code: 1867-15-880 Spinal Implant Component. All lots Class II Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER® large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head DePuy Spine, Inc.
Devices DePuy Spine VIPER POLY SCREW 5.5 8 X100MM Tl Product Code: 1867-15-899 Spinal Implant Component. All lots Class II Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER® large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head DePuy Spine, Inc.
Devices DePuy Spine VIPER POLY SCREW 5.5 9 X70MM Tl Product Code: 1867-15-970 Spinal Implant Component. All lots Class II Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER® large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head DePuy Spine, Inc.
Devices DePuy Spine VIPER POLY SCREW 5.5 9 X 80MM Tl Product Code: 1867-15-980 Spinal Implant Component. All lots Class II Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER® large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head DePuy Spine, Inc.
Devices DePuy Spine VIPER POLY SCREW 5.5 9 X100MM Tl Product Code: 1867-15-999 Spinal Implant Component. All lots Class II Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER® large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head DePuy Spine, Inc.
Devices DePuy Spine VIPER POLY SCREW 5.5 10 X 70MM Tl Product Code: 1867-15-170 Spinal Implant Component. All lots Class II Polyaxial screws 8x 8 and larger may disassociate when inserting in the Ilium., VIPER® large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head DePuy Spine, Inc.
Devices DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl Product Code: 1867-15-180 Spinal Implant Component. All lots Class II Polyaxial screws 8x 80and larger may disassociate when inserting in the Ilium., VIPER® large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head DePuy Spine, Inc.
Devices DePuy Spine VIPER POLY SCREW 5.5 10X100MM Tl Product Code: 1867-15-199 Spinal Implant Component. All lots Class II Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium. VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head DePuy Spine, Inc.
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W115112332625J; Class II Blood product, which was labeled as leukoreduced, but was not tested to verify the White Blood Cell count, was distributed. LifeSouth Community Blood Centers, Inc.
Biologics Red Blood Cells Leukocytes Reduced W087911314009; W087912302059; W087912305315; W087912605513; Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Community Blood Bank of Lancaster County Medical Society
Biologics Blood and Blood Products for Reprocessing W087911314009; W087912302059; W087912305315; W087912605513; Class III Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Community Blood Bank of Lancaster County Medical Society
Biologics Red Blood Cells Leukocytes Reduced W121612164441; Class II Blood product, collected from a donor for whom a hemoglobin screening test was not performed, was distributed. The Blood Connection, Inc.
Biologics Red Blood Cells Leukocytes Reduced Irradiated W053512014914; Class II Blood product, mislabeled as to antigen phenotype, was distributed. Central Jersey Blood Center, Inc.
Veterinary Magnolia Bird Farm Hookbill Supreme, 2 lbs. clear plastic; 5 lbs.; 10 lbs. in brown Kraft bag; 25; 50 lbs. in white paper bag;***PACKAGED BY MAGNOLIA BIRD FARM 8990 CERRITOS AVE. ANAHEIM, CA. 92804***12200 MAGNOLIA AVE. RIVERSIDE, CA. 92503. No identifying codes are used by the firm for these products Class I Magnolia Bird Farm is recalling Bird Feed Mix that contains In-Shell Peanuts from Sunland Inc. because it may be contaminated with Salmonella. Magnolia Bird Farm Inc
Veterinary Magnolia Bird Farm Conure Mix, 2 lbs. clear plastic; 5 lbs.; 10 lbs. in brown Kraft bag; 25 lbs; 50 lbs. in white paper bag;***PACKAGED BY MAGNOLIA BIRD FARM 8990 CERRITOS AVE. ANAHEIM, CA. 92804***12200 MAGNOLIA AVE. RIVERSIDE, CA. 92503 No identifying codes are used by the firm for these products Class I Magnolia Bird Farm is recalling Bird Feed Mix that contains In-Shell Peanuts from Sunland Inc. because it may be contaminated with Salmonella. Magnolia Bird Farm Inc
Veterinary Magnolia Bird Farm Parrot Mix, 3 lbs. clear plastic; 5 lbs; 10 lbs. in brown Kraft bag; 25 lbs; 50 lbs. in white paper bag.;***PACKAGED BY MAGNOLIA BIRD FARM 8990 CERRITOS AVE. ANAHEIM, CA. 92804***12200 MAGNOLIA AVE. RIVERSIDE, CA. 92503 No identifying codes are used by the firm for these products Class I Magnolia Bird Farm is recalling Bird Feed Mix that contains In-Shell Peanuts from Sunland Inc. because it may be contaminated with Salmonella. Magnolia Bird Farm Inc
Veterinary Magnolia Bird Farm Hulled Peanuts, 2 lbs. clear plastic. in ***PACKAGED BY MAGNOLIA BIRD FARM 8990 CERRITOS AVE. ANAHEIM, CA. 92804***12200 MAGNOLIA AVE. RIVERSIDE, CA. 92503. Peanuts packaged in clear plastic bags, brown Kraft bags, or white paper bags have no identifying codes. Peanuts in the original Sunland yellow mesh bag will have either best by dates from October 12, 2012 through October 12, 2013 on the packaging, or a Crop Year marking on the package of 2011 or 2012, up to and including October 12, 2012. Class I Magnolia Bird Farm is recalling Hulled Peanuts from Sunland Inc. because it may be contaminated with Salmonella. Magnolia Bird Farm Inc
Veterinary Magnolia Bird Farm Large Hookbill, 2 lbs. clear plastic; 5 lbs.; 10 lbs. in brown Kraft bag; 25 lbs; 50 lbs. in white paper bag;***PACKAGED BY MAGNOLIA BIRD FARM 8990 CERRITOS AVE. ANAHEIM, CA. 92804***12200 MAGNOLIA AVE. RIVERSIDE, CA. 92503 No identifying codes are used by the firm for these products. Class I Magnolia Bird Farm is recalling Bird Feed Mix that contains In-Shell Peanuts from Sunland Inc. because it may be contaminated with Salmonella. Magnolia Bird Farm Inc
Biologics Red Blood Cells Leukocytes Reduced W038612359432; Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. Suncoast Communities Blood Bank, Inc.
Biologics Red Blood Cells Leukocytes Reduced W036512098530; Class III Blood product, collected from a donor for whom there was no documentation on the donor record of an arm inspection, was distributed. LifeShare Blood Centers
Biologics Platelets Pheresis Leukocytes Reduced Irradiated 038GP54798; Class II Blood products, collected using a machine for which the monthly quality control testing for platelet products failed, were distributed. American Red Cross Blood Svs. Indiana-Ohio Region
Biologics Platelets Pheresis Leukocytes Reduced 038GP54750; 038GP54750; 038GP54756; 038GP54756; 038GP54772; 038GP54772; 038GP54775; 038GP54775; 038GP54779; 038GP54779; 038GP54779; 038GP54824; 038GP54824; 038GP54824; Class II Blood products, collected using a machine for which the monthly quality control testing for platelet products failed, were distributed. American Red Cross Blood Svs. Indiana-Ohio Region
Biologics Plasma Frozen 033GP62198; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. American Red Cross Blood Services
Biologics Red Blood Cells Leukocytes Reduced 033GP62198; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. American Red Cross Blood Services
Biologics Platelets Pooled Leukocytes Reduced 033GP62198; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. American Red Cross Blood Services
Biologics Source Plasma TQ196210; Class II Blood product, collected from a donor with a history of incarceration, was distributed. Knoxville Plasma Corporation
Biologics Red Blood Cells Leukocytes Reduced W089812102768; Class II Blood product, collected from a donor whose health history screening was inadequately performed, was distributed. Inova Health Care Services, Inova Blood Donor Services
Biologics Cornea 20110177; 20110178 Class II Human Corneas, recovered with a donor with risk factors for relevant communicable disease agents and diseases, were distributed. Banco de Ojos del Leonismo Puertorriqueno
Drugs Lisinopril Tablets, USP 40 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1270-01); b) 1000-count tablets per bottle (NDC 0143-1270-10); Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724; and c) 1000-count tablets per bottle (NDC 24658-245-10); Rx only, Manufactured for: Blu Pharmaceuticals, Franklin, KY 42134; Manufactured By: West-ward Pharmaceutical Corp., Eatontown, N.J. 07724. Lot #: a) and b) 69545A, 69546A, 69546B, Exp 10/15; 69547A, Exp 11/15; 69995A, 69999A, 69999B, 70000A, 70001A, 70002A, 70002B, 70003A, 70004A, Exp 02/16; c) 69548A, 69549A, Exp 11/15; 69877A, Exp 02/16 Class II Presence of Foreign Substance: Uncharacteristic black spots identified as a food grade lubicant with trace amounts of foreign particulates and stainless steel inclusions have been found in the tablets. West-ward Pharmaceutical Corp.
Drugs Propylthiouracil Tablets, USP, 50 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1480-01) and b) 1000-count tablets per bottle (NDC 0143-1480-10), Rx only, Manufactured by: West-ward Pharmaceuticals Corp. Eatontown, NJ 07724. Lot #: 68478A, 69059A, 69059B, Exp 01/16 Class II Presence of Foreign Substance: Uncharacteristic spots identified as steel corrosion, degraded tablet material and hydrocarbon oil with trace amounts of iron were found in tablets. West-ward Pharmaceutical Corp.
Devices LifeStyles Pleasure Collection 30 Premium Lubricated Condoms UPC 0-70907-02625-0. A sheath which covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). Ultra Sensitive k9983320 D050329 Flavors and Colors k00408 D046651 Skyn k070800 D046655 Thryll K941258 D046651 Thyn K941258 d046651 Ultra Thin K941258 046651 lot #120921021c Class II One lot of LifeStyles Pleasure Collection Lubricated Condoms is misbranded. Ansell Healthcare Products LLC
Food Wegmans Organic Spinach & Spring Mix --- Product is packaged in clam shell in two sizes: 5oz and 11oz. All lot codes sold between October 14, 2012 and November 1, 2012. Class I Wegmans has recalled 5 oz. and 11 oz. packages of Organic Spinach and Spring Mix Blend because the product may be contaminated with E. coli O157:H7. Wegmans Food Markets
Devices ARCHITECT 25-OH Vitamin D Reagent Kit, 03L52-25 (ROW) and 03L52-27 (U.S.) (1 x 100 tests), 03L52-35 (ROW) and 03L52-37 (U.S.) (5 x 100 tests); Abbott Laboratories, Abbott Park, IL 60064 USA, Abbott, Max-Planck-Ring 2, 65205 Wiesbaden, Germany, product of Spain; Product Usage:The ARCHITECT 25-OH Vitamin D assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 25-hydroxyvitamin D (25-OH vitamin D) in human serum and plasma. The ARCHITECT 25-OH Vitamin D assay is to be used as an aid in the assessment of vitamin D sufficiency. ARCHITECT 25-OH Vitamin D Reagent Kit list 3L52, lot numbers 02412C000, exp. 12/26/2012; 02512C000, exp. 12/26/2012; 02012G000, exp. 7/16/2013; 01612G000, exp. 7/17/13; 00912G000, exp. 7/10/13; 02512I000, exp. 10/8/2013; 02612I000, exp. 10/8/2013; 03512I000, exp. 10/10/2013; 03712I000, exp. 10/10/13; when used with ARCHITECT Reaction Vessel (RV) list 7C15-01, box lot numbers (bag lot numbers): 19320P100 (6F9891501); 19344P100 (4N5891091); 19404P100 (1J1948151); 19322P100 (LM3891731); 19373P100 (6F9891521); 19407P100 (4N5948361); 19324P100 (NK8891921); 19374P100 (JG7891631); 19408P100 (5P4948471); 19340P100 (1J1890911); 19375P100 (LM3891741); 19497P100 (2L2948281); 19341P100 (2L2891001); 19379P100 (NK8891931); 20026P100 (LM3947841) Class II The Architect 25-OH Vitamin D assay has the potential to generate falsely elevated or falsely depressed results when used with certain lots of Architect Reaction Vessels. Abbott Laboratories
Devices BD MAX (tm) (6 channel) Instruments, Catalog number 441916, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, Maryland 21152 USA*** The BD MAX" System, used in conjunction with appropriate extraction kits and reagents, is capable of automated extraction and purification of nucleic acids from multiple specimen types. The BD MAX System is also capable of automated amplification and detection of target nucleic acid sequences for use in clinical, industrial and research settings. The MAX reader assembly is the optics component of the instrument that translates PCR amplification into curves. The curves are evaluated by an algorithm when used with BD assays to interpret results. For open system reagent (OSR) users, the curve is evaluated manually to interpret the results based on their own validated criteria. The heater is part of an assembly that controls both the thermal cycling during the PCR reaction and the opening of the wax valves in the cartridge consumable. Serial Numbers: MX0001 to MX0065 CM0001 to CM0105 NOTE: Serial numbers are assigned sequentially. The above ranges will include all sequential numbers in between the beginning and end points. Class II Clinical diagnostic instrument may exhibit minor defects, which could lead to erroneous test results. Becton Dickinson & Co.
Food Cold Smoke Salmon in vacuum plastic bags, labeled in part: ***BLACK BEAR***of the BLACK FOREST*** Naturally Smoked***Smoked Salmon***Extra Fancy***1 lb.*** UPC # 810230000493 Lots = 249 thru 291 Process 2305 Class I Potential to be contaminated with Listeria Monocytogenes Marine Harvest USA, LLC
Food Cold Smoke Salmon in vacuum plastic bags. Food Service Cold Smoked Salmon Trim 1 lb. UPC # n/a Lots = 235 thru 345 Process = 7831 Class I Potential to be contaminated with Listeria Monocytogenes Marine Harvest USA, LLC
Food Cold Smoke Salmon in vacuum plastic bags, labeled in part: ***HAND-PACKED***DARN GOOD***Atlantic Smoked Salmon***KOSHER***einsteinbros.com*** UPC # 099892315200 Lots = 249 thru 291 Process = 7806 Class I Potential to be contaminated with Listeria Monocytogenes Marine Harvest USA, LLC
Food Cold Smoke Salmon in vacuum plastic bags. Food Service Whole Smoked Side. Labeled in part: ***Unsliced Cold Smoked*** Salmon Fillet Skin On*** UPC # n/a Lots = 249 thru 291 Process = 7826 & 7823 Class I Potential to be contaminated with Listeria Monocytogenes Marine Harvest USA, LLC
Food Cold Smoke Salmon in vacuum plastic bags, labeled in part: ***Silver***Source***Smoked***Salmon***Salmon Salar*** Reorders numbers= 230237 (2 Sliced Skin Off Fillets) 230251 (4-5 Sliced Skin Off Fillets) and 230254 (10 Sliced Skin Off Fillets) Process = 7843 Lots = 249 thru 291 Class I Potential to be contaminated with Listeria Monocytogenes Marine Harvest USA, LLC
Food Cold Smoke Salmon in vacuum plastic bags, labeled in part: ***Royal Fjord*** Smoked Salmon***Toppers*** 6oz UPC #: 810230000561 Lots = 235 thru 345 Process = 7968 Class I Potential to be contaminated with Listeria Monocytogenes Marine Harvest USA, LLC
Food Cold Smoke Salmon in vacuum plastic bags, labeled in part: ***SMOKED***SALMON***Deli Sliced***Ready to Serve***Royal Fjord***Center***Cut Loin*** 12 oz - Item 42925 Lots = 235 thru 345 14oz - Item 42925 Lots = 235 thru 345 Process = 7961, 7972, and 7950 Class I Potential to be contaminated with Listeria Monocytogenes Marine Harvest USA, LLC
Food Cold Smoke Salmon in vacuum plastic bags, labeled in part: ***H E B***ALL NATURAL***SMOKED***SALMON***Sliced and Ready to Serve***4 oz*** 4oz UPC # 041220630417 Lots = 249 thru 291 Process = 1936 Class I Potential to be contaminated with Listeria Monocytogenes Marine Harvest USA, LLC
Food Cold Smoke Salmon in vacuum plastic bags, labeled in part: ***Royal Fjord***Smoked Salmon***Rounds***5oz*** 4oz UPC # 810230000127 Lots = 235 thru 345 Process = 7951 Class I Potential to be contaminated with Listeria Monocytogenes Marine Harvest USA, LLC
Food Cold Smoke Salmon in vacuum plastic bags, labeled in part: ***Smoke***Nova***Salmon***Supreme Fine Foods*** 2lb*** 2 lb UPC # 852457001044 Lots = 235 thru 345 Process = 7951 Class I Potential to be contaminated with Listeria Monocytogenes Marine Harvest USA, LLC
Food Cold Smoke Salmon in vacuum plastic bags, labeled in part: ***New England Smoked Salmon*** 4oz UPC # 810230000066 Lots = 235 thru 345 Process = 7951 Class I Potential to be contaminated with Listeria Monocytogenes Marine Harvest USA, LLC
Food Diet Wild Cherry Pepsi two liter plastic bottles UPC 1234107 Best Before Date of Feb2513 and a Manufacturing Code of PF11282 Class II The labels on two-liter batches of Regular and Diet Wild Cherry Pepsi were mistakenly swapped during production. This is potential safety issue for individuals who are sensitive to phenylalanine (i.e., phenylketonuric) or who are diabetic. Pepsi Cola North America
Food Regular Wild Cherry Pepsi two liter plastic bottles UPC 1231100 Best Before Date of Feb2513 and a Manufacturing Code of PF11282 Class III The labels on two-liter batches of Regular and Diet Wild Cherry Pepsi were mistakenly swapped during production. This is potential safety issue for individuals who are sensitive to phenylalanine (i.e., phenylketonuric) or who are diabetic. Pepsi Cola North America
Food Dairy Aid Lactase Enzyme Supplement, Caplet, 3,000 FCC Units, 60 caplets, OTC, Repackaged by: Cardinal Health, Zanesville, OH 43701, NDC 55154-1335-4 White, oblong caplet, imprinted RP143; Batch# M675030, Lot # 10627AA, Exp Date 11/2012; Batch# M679370, Lot # 10627BA, Exp Date 12/2012; Batch# M675020, Lot # 10627A, Exp Date 11/2012; Batch# M679360, Lot # 10627B, Exp Date 12/2012; Batch# M707960, Lot # 10627C, Exp Date 3/2013; Batch# M712800, Lot # 11469A, Exp Date 3/2013; Batch# M740490, Lot # 11464B, Exp Date 6/2013; Batch# M743510, Lot # 13973A, Exp Date 7/2013. Class II The firm discovered that the labeling bears an incorrect strength of 9,000 FCC Units per caplet instead of 3,000 FCC units per caplet. Cardinal Health
Food Tzatziki; Greek yogurt with cucumber and dill. sold in 8 oz retail and 5 lb bulk food service containers. Undeclared milk. Manufactured by Haigs Delicacies, Hayward, CA. all products Class I State of CA inspection found four products that do not declare allergy statements which reflect the use of milk, wheat and eggs. Haig's Delicacies
Food Falafel with Tahini Sauce; nuggets of ground garbanzo beans with a rich, tangy tahini sauce. Sold in 5 oz retail rectangular deli containers and 5 lb bulk foodservice. Undeclared wheat Manufactured by Haigs Delicacies, Hayward, CA. all products Class II State of CA inspection found four products do not declare allergy statements which reflect the use of milk, wheat and eggs. Haig's Delicacies
Food Spanakopita; a triangular phyllo dough pastry with spinach and cheese filling. sold in 5 lb. bulk Foodservice cases. Undeclared wheat, milk and eggs Manufactured by Haig's Delicacies, Hayward, CA. all products Class I State of CA inspection found four products that do not declare allergy statements which reflect the use of milk, wheat and eggs. Haig's Delicacies
Food Tyropita; a triangular phyllo dough pastry with cheese filling. sold in 5 lb. bulk Foodservice cases . Undeclared wheat, milk and eggs. Manufactured by Haig s Delicacies, Hayward, CA. all products Class I State of CA inspection found four products that do not declare allergy statements which reflect the use of milk, wheat and eggs. Haig's Delicacies
Devices BBL Crystal Enteric/Nonfermenter ID Kit, Catalog # 24500, cartons of 20 kits, labeled in part ***Becton, Dickinson and Company, Sparks MD 21152*** The BBL Crystal Enteric/Nonfermentor (E/NF) identification (ID) System is for the identification of aerobic gram-negative bacteria that belong to the family Enterobacteriaceae as well as some of the more frequently isolated glucose fermenting and nonfermenting gram-negative bacilli. Lot Number/ Exp Date 2086315 February 20, 2013 2101435 February 20, 2013 2104316 February 27, 2013 2129460 February 27, 2013 2129487 March 13, 2013 2163211 February 27, 2013 2163213 March 20, 2013 2163215 March 27, 2013 Class II In-vitro diagnostic reagents for microbiological testing may be reversed in well positions in the test kit and when utilized may lead to bacteria misidentification. Becton Dickinson & Co.
Devices Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code: BH-2035PE Product Usage: Medisystems Buttonhole Needle Sets are indicated for use as an access device for dialysis and pheresis procedures using a constant site orbuttonhole method of needle insertion. Lot: 120719F4 Class II A total of 5 (ea) single needle pouches are mislabeled as 15 Ga x1" instead of 15 Ga x 3/5". Medisystems a NX Stage Company
Devices Medisystems 17 Gauge x 1" inch AV Fistula Needle Product Code: D9-2007MGLB Product Usage: Medisystems AVF with MasterGuard anti-stick needle protector is indicated for use as a vascular access device in hemodialysis or other extracorporeal procedures. It is intended for use in conjunction with a blood tubing set equipped with a standard medical male luer-locking connector Lot: Number: 110914F8 Class II Single needle packs in each case ( 10 needles per case) are mislabeled on the pouch as 15 Gauge needles instead of 17 Gauge Medisystems a NX Stage Company
Drugs Lisinopril and Hydrochlorothiazide Tablets, 20 mg/25 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1264-01) and b) 1000-count tablets per bottle (NDC 0143-1264-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724. Lot #: 69392A, 69393A, 69394A, 69395A, 69396A, 69397A , Exp 09/15; 69495A, 69496A, 69497A, 69498A, 69524A, 69525A, Exp 10/15 Class II Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel particulates were found in the recalled tablets. West-ward Pharmaceutical Corp.
Drugs PredniSONE Tablets, USP, 20 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1477-01), b) 500-count tablets per bottle (NDC 0143-1477-05), and c) 1000-count tablets per bottle (NDC 0143-1477-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatowntown, NJ 07724. Lot #: 68581A, 68581B, 68382A, 68382B, 68578A, 68578B, 68579A, 68580A, 68582A, 68582B, Exp 01/15 Class II Presence of Foreign Substance: A complaint was received for black specks identified as stainless steel inclusions and cellulose with trace amounts of aluminum and iron-rich inclusions. West-ward Pharmaceutical Corp.
Devices GreenLight HPS (High Performance System) GreenLight XPS ( Xcelerated Performance System) Manufactured by AMS, Solutions for Life Innovation Center - Silicon Valley, 3070 Orchard Drive, San Jose, CA 95134. GreenLight HPS and XPS Surgical Lasers Systems and accessories are intended for use in endoscopic 532 nm laser resection of the prostate for the treatment of benign prostatic hyperplasis. The entire laser unit and controls are contained in a single console that is connected to external electricity and are required to meet IEC 60601. HPS Part numbers: 0010-0070 to 0010-0077; XPS Part numbers: 0010-0210 Serial numbers: HPS2095R1 HPS3079C2 HPS3080C1 HPS3089C1 HPS3091C1 HPS3096C1 HPS3099C1 HPS3100C1 HPS3101C1 HPS3102C1 HPS3103 HPS3104C1 HPS3105C1 HPS3107 HPS3108C1 HPS3109C1 HPS3110C2 HPS3112 HPS3113 HPS3114 HPS3115 HPS3116 HPS3117 HPS3118 HPS3119 HPS3120 HPS3121 HPS3122 HPS3123 HPS3124 HPS3125 HPS3126 HPS3127 HPS3128 HPS3129 HPS3130 HPS3131 HPS3132 HPS3134 HPS3136 HPS3137 HPS3139 HPS3142 HPS3143 HPS3144 HPS3145 XPS50084 XPS50241 XPS50301 XPS50302 XPS50312 XPS50313 XPS50314 XPS50315 XPS50316 XPS50317 XPS50318 XPS50319 XPS50320 XPS50321 XPS50322 XPS50323 XPS50324 XPS50325 XPS50326 XPS50327 XPS50328 XPS50329 XPS50330 XPS50331 XPS50332 XPS50333 XPS50334 XPS50335 XPS50336 XPS50337 XPS50338 XPS50339 XPS50340 XPS50341 XPS50342 XPS50343 XPS50344 XPS50345 XPS50346 XPS50347 XPS50348 XPS50349 XPS50350 XPS50351 XPS50352 XPS50353 XPS50354 XPS50355 XPS50356C1 XPS50357 XPS50358 XPS50359 XPS50360 XPS50361 XPS50362 XPS50363 XPS50364 XPS50367 XPS50368 XPS50369 XPS50371 XPS50372C1 XPS50373 XPS50374 XPS50375 XPS50376 XPS50377 XPS50378 XPS50379 XPS50380 XPS50381 XPS50382 XPS50383 XPS50384 XPS50385 XPS50386 XPS50388 XPS50389 XPS50390 XPS50391 XPS50392 XPS50393 XPS50394 XPS50395 XPS50396 XPS50397 XPS50398 XPS50399 XPS50400 XPS50401 XPS50402 XPS50403 XPS50404 XPS50405 XPS50406 XPS50407 XPS50408 XPS50409 XPS50410 XPS50412 XPS50413 XPS50414 XPS50415 XPS50416 XPS50417 XPS50418 XPS50419 XPS50420 XPS50421 XPS50422 XPS50423 XPS50424 XPS50426C1 XPS50427 XPS50428 XPS50430 XPS50431 XPS50432 XPS50433 XPS50434 XPS50435C1 XPS50436 XPS50437C1 XPS50438 XPS50439 XPS50440 XPS50441 XPS50442 XPS50443 XPS50444 XPS50446 XPS50447 XPS50448 XPS50449 XPS50450 XPS50451 XPS50452 XPS50453 XPS50454 XPS50455 XPS50456 XPS50457 XPS50458 XPS50459 XPS50460 XPS50461 XPS50462 XPS50463 XPS50464 XPS50465 XPS50466 XPS50467 XPS50468 XPS50469 XPS50470 XPS50471 XPS50472 XPS50473 XPS50474 XPS50475 XPS50476 XPS50477C1 XPS50478 XPS50479 XPS50480 XPS50481 XPS50482 XPS50483 XPS50484 XPS50485 XPS50486 XPS50487 XPS50488 XPS50489 XPS50490 XPS50491 XPS50492 XPS50493 XPS50494C1 XPS50495 XPS50496 XPS50497 XPS50498 XPS50499 XPS50500 XPS50501 XPS50502 XPS50503 XPS50504 XPS50505 XPS50506 XPS50507 XPS50508 XPS50509 XPS50510 XPS50512 XPS50513 XPS50514 XPS50516 XPS50517 XPS50518 XPS50519 XPS50520 XPS50521 XPS50522 XPS50523 XPS50525 XPS50526 XPS50527 XPS50528 XPS50529 XPS50531 XPS50532 XPS50534 XPS50535 XPS50536 XPS50537 XPS50538 XPS50539 XPS50540 XPS50541 XPS50542 XPS50543 XPS50544 XPS50545 XPS50546 XPS50547 XPS50548 XPS50549 XPS50550 XPS50551 XPS50552 XPS50553 XPS50554 XPS50555 XPS50556 XPS50557 XPS50558 XPS50559 XPS50560 XPS50561 XPS50562 XPS50563 XPS50564 XPS50565 XPS50566 XPS50567 XPS50568 XPS50570 XPS50572 XPS50573 XPS50574 XPS50575 XPS50576 XPS50577 XPS50578 XPS50579 XPS50580 XPS50581 XPS50582 XPS50583 XPS50584 XPS50585 XPS50586 XPS50587 XPS50588 XPS50589 XPS50590 XPS50591 XPS50592 XPS50593 XPS50594 XPS50595 XPS50596 XPS50597 XPS50598 XPS50599 XPS50600 XPS50601 XPS50602 XPS50603 XPS50604 XPS50606 XPS50607 XPS50608 XPS50610 XPS50611 XPS50612 XPS50613 XPS50614 XPS50615 XPS50616 XPS50617 XPS50618 XPS50619 XPS50620 XPS50621 XPS50622 XPS50623 XPS50624 XPS50625 XPS50627 XPS50628 XPS50629 XPS50630 XPS50631 XPS50632 XPS50634 XPS50635 XPS50636 XPS50637 XPS50638 XPS50640 XPS50641 XPS50642 XPS50643 XPS50644 XPS50645 XPS50646 XPS50647 XPS50648 XPS50649 XPS50650 XPS50651 XPS50652 XPS50653 XPS50654 XPS50655 XPS50656 XPS50657 XPS50658 XPS50659 XPS50660 XPS50661 XPS50662 XPS50663 XPS50671 XPS50674 XPS50675 XPS50676 XPS50680 XPS50681 XPS50684. Class II During electrical recertification testing it was found that the Voltage Scaling Board was non-conforming to the IEC 60601-1-2 standard. AMS Innovative Center - San Jose
Devices ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - SHARP, Disposable Hyfrecator(R) Tips, REF/Catalog No. 7-100-8CS, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH RD., UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D092250. The Electrolase® Sterile Disposable Electrodes are intended to be used as active RF electrodes for desiccation, fulguration and coagulation. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a "non-stick" finish. The Single Use ABC® Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding. Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)]. Class II ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use. ConMed Corporation
Devices ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT, Disposable Hyfrecator(R) Tips, REF/Catalog No. 7-101-8CS, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH RD., UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL 092250. The Electrolase® Sterile Disposable Electrodes are intended to be used as active RF electrodes for desiccation, fulguration and coagulation. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a "non-stick" finish. The Single Use ABC® Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding. Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)]. Class II ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use. ConMed Corporation
Devices Goldvac(TM) UltraClean(R) Accessory Electrode 1 inch Coated Blade with Extended Insulation, REF/Catalog No. 60-7521-001, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH ROAD, UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D085930. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a "non-stick" finish. The Single Use ABC® Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding. Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)]. Class II ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use. ConMed Corporation
Devices Goldvac(TM) UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extended Insulation, REF/Catalog No. 60-7523-001, Sterile, Rx ONLY -- CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D085930. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a "non-stick" finish. The Single Use ABC® Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding. Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)]. Class II ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use. ConMed Corporation
Devices Goldvac(TM) UltraClean(R) Accessory Electrode 4 inch Coated Blade, REF/Catalog No. 60-7524-001, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH ROAD, UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D085930. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a "non-stick" finish. The Single Use ABC® Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding. Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)]. Class II ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use. ConMed Corporation
Devices Goldvac(TM) UltraClean(R) Accessory Electrode 6 inch Coated Blade, REF/Catalog No. 60-7526-001, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH RD., UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D085930. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a "non-stick" finish. The Single Use ABC® Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding. Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)]. Class II ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use. ConMed Corporation
Devices ABC(R) NOZZLE, Single Patient Use Nozzle, (For use with 130500 Reusable ABC(R) Handpiece), REF/Catalog No. 130343, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH RD., UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL E323246. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a "non-stick" finish. The Single Use ABC® Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding. Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)]. Class II ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use. ConMed Corporation
Devices TUR/Endoscopic Cable, 10 feet (3.05 mm), REF/Catalog No. 135171, Disposable, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH RD., UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D092258. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a "non-stick" finish. The Single Use ABC® Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding. Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)]. Class II ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use. ConMed Corporation
Devices CONMED(R) ELECTROSURGICAL SAFETY HOLSTER, Disposable Safety Holster, REF/Catalog No. 137668, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH RD., UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D092249. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a "non-stick" finish. The Single Use ABC® Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding. Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)]. Class II ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use. ConMed Corporation
Devices ELECTROSURGICAL ENT NEEDLE ELECTRODE, 6 inch with Extended Insulation, REF/Catalog No. 138025, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH RD., UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D092258. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a "non-stick" finish. The Single Use ABC® Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding. Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917 X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)]. Class II ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use. ConMed Corporation
Devices Electrosurgical Tip Cleaner, REF/Catalog No. 138029, Single Use, Sterile, Rx ONLY -- Distributed By: CONMED CORPORATION 525 French Road, Utica, NY 13502-5944 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D092281. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a "non-stick" finish. The Single Use ABC® Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding. Beginning Lot Code 120628X, Ending Lot Code 120725X. [Lot codes on boxes and packaging contain a lot code in the following form: 120725X where 12 represents the year (2012), 07 represents the month (July), 25 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)]. Class II ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use. ConMed Corporation
Devices UltraClean(R) Accessory Electrode, 1 inch Coated Blade, REF/Catalog No. 139100, Single Use, Sterile, Rx ONLY --CONMED CORPORATION, UTICA, NY 13502 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D085930. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a "non-stick" finish. The Single Use ABC® Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding. Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 12 09 17 X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)]. Class II ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use. ConMed Corporation
Devices UltraClean(R) Accessory Electrode 1 inch Coated Needle, REF/Catalog No. 139102, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH ROAD, UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D085930. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a "non-stick" finish. The Single Use ABC® Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding. Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)]. Class II ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use. ConMed Corporation
Devices UltraClean(R) Accessory Electrode 1 inch Coated Blade with Extended Insulation, REF/Catalog No. 139104EXT, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH ROAD, UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D085930. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a "non-stick" finish. The Single Use ABC® Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding. Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)]. Class II ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use. ConMed Corporation
Devices UltraClean(R) Accessory Electrode 1 inch Coated Needle with Extended Insulation, REF/Catalog No. 139105EXT, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH ROAD, UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D085930. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a "non-stick" finish. The Single Use ABC® Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding. Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)]. Class II ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use. ConMed Corporation
Devices UltraClean(R) Accessory Electrode 6 inch Coated Blade, REF/Catalog No. 139107, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION, 525 FRENCH RD., UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D085930. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a "non-stick" finish. The Single Use ABC® Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding. Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)]. Class II ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use. ConMed Corporation
Devices UltraClean(R) Accessory Electrode 6 inch Coated Needle with Extended Insulation, REF/Catalog No. 139108, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH ROAD, UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D085930. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a "non-stick" finish. The Single Use ABC® Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding. Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)]. Class II ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use. ConMed Corporation
Devices UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extended Insulation, REF/Catalog No. 139110EXT, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH ROAD, UTICA, NY 13502-5944 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D085930. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a "non-stick" finish. The Single Use ABC® Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding. Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)]. Class II ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use. ConMed Corporation
Devices UltraClean(R) Accessory Electrode 4 inch Coated Blade, REF/Catalog No. 139112, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH ROAD, UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D085930. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a "non-stick" finish. The Single Use ABC® Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding. Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)]. Class II ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use. ConMed Corporation
Devices UltraClean(R) Accessory Electrode 4 inch Coated Blade with Extended Insulation, REF/Catalog No. 139112EXT, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH ROAD, UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D085930. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a "non-stick" finish. The Single Use ABC® Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding. Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)]. Class II ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use. ConMed Corporation
Food Coca-Cola, 12 fluid ounce aluminum cans in 20-packs and 32-packs, The Coca Cola Company. UPC: 496340, Optimum Taste Code: SEP1613HWA Class III Complaints received of off taste/odor. Coca-Cola Company (The)
Food Andy Capp's Cheddar Cheese Fries packaged in Andy Capp's Hot Fries, 0.85-oz foil bags, snack size, Case UPC: 20-0-26200-47169-7 and Unit UPC: 00-0-26200-47168-6. Best By: AUG 17 13 and (batch number) 5381232500 Class II Andy Capp's Cheddar Cheese Fries snacks were packaged in Andy Capp's Hot Fries snack bags in error. The Cheddar Cheese Fries contain Soy which is not listed on the ingredients label of the Hot Fries bag. Conagra Inc
Devices Abbott Point of Care i-Stat cTnI cartridge. The i-Stat cardiac troponin I (cTnI) test is an in vitro diagnostic test for the quantitive measurement of cardiac troponin I (cTnI) in whole blood or plasma. Measurements of cardiac troponin I are used in the diagnosis and treatment of myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes with respect to the relative risk of mortality. List number 06F15-03, O6F15-04, 03P90-25, 600-9009-25 Lot number P12179 Class II APOC has determined that 10 boxes of i-Stat cTnI cartridges from lot P12179 have an incorrect barcode applied to the cartridge portion pack. Abbott Point of Care Canada Limited
Drugs Flanax (aluminum hydroxide, magnesium hydroxide, and simethicone) Fast Acting Antacid, 200 mg/200 mg/20 mg, 12 fl oz (355 mL) bottles, Distributed by: Belmora LLC, PO Box 3063, Arlington, VA 22203, UPC 8 53030 00209 0, NDC 27854.101.01. Lot #: 1321, 1322, 1323, and 1324 Class III Defective Container: Product lacks tamper evident breakaway band on cap. Belmora LLC
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