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U.S. Department of Health and Human Services

Enforcement Report - Week of May 15, 2013

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Micro SSP DNA Typing Trays Micro SSP Allele Specific HLA Class I Typing Tray - A*11 Article Number: SSP_DNAT_PI Rev 18 510(K) Number : BK960062 Catalog Identification: SSP1-11 (Lot Number: 002) and SSPR1-11 (Lot Number: 003). Class III Micro SSP DNA Typing Trays of HLA Class I and Class II alleles, where null allele entries were not properly verified and may cause misassignment, were distributed. One Lambda Inc
Biologics Micro SSP DNA Typing Trays Micro SSP Allele Specific HLA Class I Typing Tray - A*26 Article Number: SSP_DNAT_PI Rev 18 510(K) Number : BK960062 Catalog Identification: SSP1-26 Lot Number: 01A Class III Micro SSP DNA Typing Trays of HLA Class I and Class II alleles, where null allele entries were not properly verified and may cause misassignment, were distributed. One Lambda Inc
Biologics Micro SSP DNA Typing Trays Micro SSP High Resolution HLA Class II DNA Typing Tray Article Number: SSP_DNAT_PI Rev 18 510(K) Number : BK960062 Catalog Identification: SSP2H Lot Number: 04A and 005 Class III Micro SSP DNA Typing Trays of HLA Class I and Class II alleles, where null allele entries were not properly verified and may cause misassignment, were distributed. One Lambda Inc
Biologics Micro SSP DNA Typing Trays Micro SSP Generic HLA Class II DNA Typing Tray Article Number: SSP_DNAT_PI Rev 18 510(K) Number : BK960062 Catalog Identification: SSP2L Lot Number: 007 Class III Micro SSP DNA Typing Trays of HLA Class I and Class II alleles, where null allele entries were not properly verified and may cause misassignment, were distributed. One Lambda Inc
Biologics Micro SSP DNA Typing Trays Micro SSP Generic HLA Class II DNA Typing Tray - DRB Only Article Number: SSP_DNAT_PI Rev 18 510(K) Number : BK960062 Catalog Identification: SSP2LB Lot Number: 004 Class III Micro SSP DNA Typing Trays of HLA Class I and Class II alleles, where null allele entries were not properly verified and may cause misassignment, were distributed. One Lambda Inc
Biologics Micro SSP DNA Typing Trays Micro SSP HLA Class I and II ABDR DNA Typing Tray Article Number: SSP_DNAT_PI Rev 18 510(K) Number : BK960062 Catalog Identification: SSPABDR (Lot Number: 008 and 009) and SSPABDRX (Lot Number: 008 and 009) Class III Micro SSP DNA Typing Trays of HLA Class I and Class II alleles, where null allele entries were not properly verified and may cause misassignment, were distributed. One Lambda Inc
Biologics Micro SSP DNA Typing Trays Micro SSP Generic HLA Class II DNA Typing Tray - DRB/DQB1/DPB1 Article Number: SSP_DNAT_PI Rev 18 510(K) Number : BK960062 Catalog Identification: SSPDRQP1 Lot Number: 001 Class III Micro SSP DNA Typing Trays of HLA Class I and Class II alleles, where null allele entries were not properly verified and may cause misassignment, were distributed. One Lambda Inc
Biologics Micro SSP DNA Typing Trays Micro SSP Generic HLA Class I and II DNA Typing Tray - ABDRDQ Article Number: SSP_DNAT_PI Rev 18 510(K) Number : BK960062 Catalog Identification: SSPML02 Lot Number: 003 and 004 Class III Micro SSP DNA Typing Trays of HLA Class I and Class II alleles, where null allele entries were not properly verified and may cause misassignment, were distributed. One Lambda Inc
Biologics Red Blood Cells Leukocytes Reduced 09GV13749; 09GV14552; 09GV15492 Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. American Red Cross Blood Services
Biologics Red Blood Cells Leukocytes Reduced 20LY55510 , 20LY55518 , 20LS22792 , 20LS22257 , 20LS22898 , 20lC72098 , 20LY56192 , 20LS22666 , 20LS22667 , 20LS22801 , 20LS22923 , 20LS22744 , 20LS22729 , 20LS22746 , 20lS22562, 20LY56070, 20LS22616, 20LS22684 , 20LS22800, 20LS22808 , 20LS22965, 20LS22967, 20LS22997, 20LS23042 , 20LY56948, 20LS22622 , 20LS22757, 20LS22760 , 20LS22865, 20LY56958, 20LS22585,  ...
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Class II Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed. American National Red Cross
Biologics Fresh Frozen Plasma 20lS22585 , 20LS22487 , 20LS22490 , 20LS22594 , 20LS22622 , 20LS22794 , 20LS22784 , 20LS22789 , 20LS22800 , 20LS22801 , 20LS22808 , 20LS22744 , 20LY56070, 20LS22797, 20LS22792, 20LS22357, 20LY56098, 20LS22352, 20LS22804, 20LS22354, 20LY56084, 20LY56087, 20LC72098, 20LS22785. Class II Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed. American National Red Cross
Biologics Red Blood Cells Leukocytes Reduced Washed 20LS22919. Class II Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed. American National Red Cross
Biologics Plasma Frozen 20LS22612, 20LS22562, 20LY56192. Class II Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed. American National Red Cross
Biologics Red Blood Cells Leukocytes Reduced. The responsible firm listed on the product label is American Red Cross Blood Services. 11KC13068 11KL07945 11KL08058 11LZ28121 11LZ28895 11GP17262 11GP17265 11GP17267 11GP17268 11LE26225 11LC92484 11LC92498 11KL08331 11KL08340 11KL08348 11KL08351 11KL08352 11KL08440 11KL08455 11KL08479 11LQ39167 11LQ39169 11LQ39171 11LQ39175 11LQ39217 11LQ39227 11KE50300 11KE50301 11KE50305 11KE50306 11KE50310 11KE50320 11KE50321 11KE50326 11LE26545 11LE26548 11LE26554 11LE26563 11LE26575 11LE26622 11LE26627 11LE26632 11LE26687 11KY07350 11KY07378 11LE27054 11KV05165 11KV05167 11KV05184 11LE27087 11LE27171 11LE27182 11LE27187 11LE27199 11KV05213 11KV05223 11KV05225 11KV05291 11KY07612 11KY07615 11KY07641 11KY07642  ...
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Class II Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed. American Red Cross Blood Services
Biologics Plasma Frozen. The responsible firm listed on the product label is American Red Cross Blood Services. 11LE26225 11LE26231 11LE26234 11LC92535 11KE50301 11KE50310 11KE50315 11KE50320 11KE50321 11KE50326 11KE50329 11LE26545 11LE26563 11LE26687 11LE26697 11LE27044 11KV05167 11LE27080 11LE27087 11LE27154 11LE27175 11KV05273 11KY07615 11KY07633 11KY07639 11KY07645 11LC92861 11LE27502 11KV05636 11KV05639 11LE27581 11LJ92554 11LJ92559 11LJ92562 11LE27587 11LE27589 11LE27590 11LE27631 11LE27638 11LE27681 Class II Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed. American Red Cross Blood Services
Biologics Red Blood Cells. The responsible firm listed on the product label is American Red Cross Blood Services. 11LC92381 11LC92384 11LC92388 11LC92390 11LE26231 11LE26234 11LC92535 11LQ39216 11LE26681 11LE26697 11LE26704 11LE26741 11LE27040 11LE27044 11LE27052 11KV05210 11KV05217 11KV05220 11KV05244 11LQ39475 11LQ39479 11LQ39501 11LQ39502 11KV05273 11KV05292 11KY07606 11KY07607 11KY07633 11KY07639 11LC92854 11LC92855 11LC92857 11LC92858 11KV05636 11KV05639 11KV05640 11KV05642 11KV05644 11KV05646 11KV05655 11LE27581 11LE27583 11KV05688 11KV05698 11KV05700 11LJ92554 11LJ92558 11LJ92559 11LJ92562 11LJ92568 11LJ92570 11LE27589 11LE27629 11LE27632 11LE27636  ...
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Class II Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed. American Red Cross Blood Services
Biologics Fresh Frozen Plasma. The responsible firm listed on the product label is American Red Cross Blood Services. 11LZ28895 11GP17262 11GP17265 11GP17267 11GP17268 Class II Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed. American Red Cross Blood Services
Biologics Cryoprecipitated AHF. The responsible firm listed on the product label is American Red Cross Blood Services. 11GK84919 11GK84923 11GK84925 11GK84926 11GK84928 11GK84930 11GK84932 Class II Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed. American Red Cross Blood Services
Biologics Platelets. The responsible firm listed on the product label is American Red Cross Blood Services. 11LE27830 Class II Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed. American Red Cross Blood Services
Biologics Red Blood Cells Leukocytes Reduced 36Q78865 Class II Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed. The American National Red Cross South Carolina Region
Biologics Blood and Blood Products for Reprocessing 36Q78865 Class II Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed. The American National Red Cross South Carolina Region
Biologics Source Plasma RH0019179 Class II Blood product, quality control and distribution/required testing not performed for HIV/HCV Nucleic Acid Test (NAT), was distributed. Cangene Corporation - Rh Plasma Center
Biologics Platelets Pheresis Leukocytes Reduced, Part 1 of 3, Part 2 of 3 and Part 3 of 3. 9912770 (Part A); 9912770(Part B); 9912770(Part C) Class II Blood products, platelet pheresis leukocytes reduced with an unacceptable pH, were distributed. Florida's Blood Centers, Inc.
Biologics Source Plasma 08CIAB7249 Class II Blood products, collected from a donor who was not asked vCJD travel questions, was distributed. BioLife Plasma Services L.P.
Biologics Cryoprecipitate AHF 4411171 Class II Blood products, collected from a donor who provided a different last name, were distributed. Florida Blood Services, Inc.
Biologics Red Blood Cells Leukocytes Reduced 2004692 Class III Blood products, collected from donors whose hematocrits were determined using an analyzer with an invalid QC control, were distributed. Upstate New York Transplant Services
Biologics Blood and Blood Products for Reprocessing Recovered Plasma Cryoprecipitate Reduced. 5699436 Class II Blood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Florida's Blood Centers, Inc.
Biologics Fresh Frozen Plasma 574252 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Florida's Blood Centers, Inc.
Biologics Recovered Plasma Frozen within 24 Hour of Phlebotomy (Blood and Blood Products for Reprocessing). 5575117; 5266741 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Florida's Blood Centers, Inc.
Biologics Source Plasma 366051639;366053393;366053758;366054269;366055108;366055486;366057062;366058924;366059301;366073292;366073628;366077496 Class II Blood products, collected from a donor who was permanently deferred, were distributed. Talecris Plasma Resources, Inc.
Devices Mercury Spinal System DIA 5.5 x 30 MM Lordosed Rod, Part Number: 60100-030. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Lot Number: 080582 Class III Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Spinal Elements, Inc
Devices Mercury Spinal System DIA 5.5 x 40 MM Lordosed Rod, Part Number: 60100-040. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Lot Number: 080583 Class III Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Spinal Elements, Inc
Devices Mercury Spinal System DIA 5.5 x 50 MM Lordosed Rod, Part Number: 60100-050. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Lot Number: 080584 Class III Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Spinal Elements, Inc
Devices Mercury Spinal System DIA 5.5 x 60 MM Lordosed Rod, Part Number: 60100-060. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Lot Number: 080585 Class III Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Spinal Elements, Inc
Devices Mercury Spinal System DIA 5.5 x 70 MM Lordosed Rod, Part Number: 60100-070. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Lot number: 080586 Class III Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Spinal Elements, Inc
Devices Mercury Spinal System DIA 5.5 x 80 MM Lordosed Rod, Part Number: 60100-080. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Lot number: 080587 Class III Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Spinal Elements, Inc
Devices Mercury Spinal System DIA 5.5 x 90 MM Lordosed Rod, Part Number: 60100-090. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Lot Number: 080588 Class III Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Spinal Elements, Inc
Devices Mercury Spinal System DIA 5.5 x 100mm Lordosed Rod, Part Number: 60100-100. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Lot Number: 080589 Class III Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Spinal Elements, Inc
Devices Mercury Spinal System DIA 5.5 x 110mm Lordosed Rod, Part Number: 60100-110. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Lot number: 080590 Class III Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Spinal Elements, Inc
Devices Mercury Spinal System DIA 5.5 x 120mm Lordosed Rod, Part Number: 60100-120. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Lot Number: 080591 Class III Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Spinal Elements, Inc
Devices Mercury Spinal System DIA 5.5 x 30mm Straight Rod, Part Number: 60101-030. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Lot number: 080592 Class III Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Spinal Elements, Inc
Devices Mercury Spinal System DIA 5.5 x 40mm Straight Rod, Part Number: 60101-040. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Lot Number: 080593 Class III Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Spinal Elements, Inc
Devices Mercury Spinal System DIA 5.5 x 50mm Straight Rod, Part Number: 60101-050. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Lot Number: 080594 Class III Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Spinal Elements, Inc
Devices Mercury Spinal System DIA 5.5 x 60mm Straight Rod, Part Number: 60101-060. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Lot Number: 080594 Class III Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Spinal Elements, Inc
Devices Mercury Spinal System DIA 5.5 x 70mm Straight Rod, Part Number: 60101-070. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Lot Number: 080596 Class III Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Spinal Elements, Inc
Devices Mercury Spinal System DIA 5.5 x 80mm Straight Rod, Part Number: 60101-080. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Lot Number: 080597 Class III Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Spinal Elements, Inc
Devices Mercury Spinal System DIA 5.5 x 90mm Straight Rod, Part Number: 60101-090. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Lot Number: 080598 Class III Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Spinal Elements, Inc
Devices Mercury Spinal System DIA 5.5 x 100mm Straight Rod, Part Number: 60101-100. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Lot Number: 080599 Class III Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Spinal Elements, Inc
Devices Mercury Spinal System DIA 5.5 x 110mm Straight Rod, Part Number: 60101-110. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Lot Number: 080600 Class III Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Spinal Elements, Inc
Devices Mercury Spinal System DIA 5.5 x 120mm Straight Rod, Part Number: 60101-120. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Lot Number: 080601 Class III Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Spinal Elements, Inc
Devices Mercury Spinal System DIA 5.5 x 400mm Straight Rod, Part Number: 60101-400. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Lot Number: 080602 Class III Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Spinal Elements, Inc
Devices KARL STORZ Photodynamic Diagnosis (PDD) D-Light C System, Instruction Manuals: PDD Telescopes, Tricam SL II, and PDD Camera Heads. Used as an optional accessory to white light cystoscopy when used in combination with the diagnostic imaging drug Cysview. The device Instruction Manual recall, which includes: 1) Telescope, 2) Camera Head, and 3) Camera System. Serial Numbers: ZZ2008 ZZ2016 ZZ2012 ZZ2019 TY2024 ZZ2013 TY2026 TY2025 TY2028 TY2021 ZZ2007 ZZ2020 TX2036 TX2033 ZZ2017, and TX2035. Class II The recall was initiated because Karl Storz has confirmed that the Photodynamic Diagnosis (PDD) D-Light C System instruction manuals have important safety-related changes. Karl Storz Endoscopy America Inc
Biologics Plasma Frozen within 24 hours (FP24) 22GM75439; Class II Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. American National Red Cross, Penn-Jersey Region
Biologics Red Blood Cells Leukocytes Reduced W045212014473; Class II Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed. South Bend Medical Foundation, Inc.
Biologics Blood and Blood Products for Reprocessing M169858; Class II Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. Puget Sound Blood Center and Program
Biologics Source Plasma 3580167569; 3580167563; 3580167559; 3580167571; 3580167556; 3580167561; 3580167570; 3580168680; 3580168682; 3580168671; 3580168689; 3580168669; 3580168688; 3580168687; Class II Blood products, which were not tested for viral markers, were distributed. Talecris Plasma Resources Inc
Biologics Whole Blood W140512443683; Class II Blood product, collected from an autologous donor but incorrectly labeled as a homologous unit, was distributed. The Children's Hospital Assoc. Transfusion Medicine Services
Biologics Platelets Pheresis Leukocytes Reduced W227712044243; W227712044243; Class II Blood products, with pH below the acceptable level, were distributed. Mid-South Regional Blood Center
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W313712015322; Class II Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed. Hemacare Corporation
Biologics Red Blood Cells Leukocytes Reduced Washed W045012093999; Class III Blood product, with an unacceptably low red cell recovery rate, was distributed. Community Blood Center Of Gtr KC
Biologics Red Blood Cells Leukocytes Reduced P60990; Class II Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. Blood Assurance Inc
Biologics Red Blood Cells Leukocytes Reduced W137512111712; W137512107157; Class II Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed Lane Memorial Blood Bank
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W04211091240; W04211091240; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Blood Assurance Inc
Biologics Source Plasma 3270201511; 3270200643; 3270200313; 3270198380; 3270198053; 3270197360; 3270196575; 3270196161; 3270193616; 3270192348; 3270191920; 3270191241; 3270190571; 3270190209; 3270189435; 3270189193; 3270188499; 3270188060; 3270187611; 3270186965; 3270186130; 3270185752; 3270185277; 3270184766; 3270184130; 3270183856; 3270179389; 3270178907; 3270177534; Class II Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed. Talecris Plasma Resources, Inc.
Biologics Source Plasma 12GINB4552; Class III Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed. Bio-Blood Components, Inc.
Biologics Red Blood Cells Leukocytes Reduced W041512052481*; Class III Blood product, collected from a donor whose medical history screening was not adequately performed, was distributed. Blood Systems, Inc. dba United Blood Services
Devices BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack, REF 441124, contains 12 each Microwells labeled in part ***BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack REF 441124 ***For use with the BD Viper System *** Becton, Dickinson and Company 7 Loveton Circle, Sparks, MD 21152 USA www.bd.com/ds EC REP Benex Limited, Pottery Road, Dun Laoghaire, Co. Dublin, Ireland. Assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of gonococcal urogenital disease. Lot No./Exp. Date: 2237214 / 2013-10-31. Class II Increased levels of false positives in BD Probe Tech Neisseria gonorrhoeae Q Amplified DNA assay kits. Becton Dickinson & Co.
Veterinary Iams Shakeables Gobble em Up With Turkey for Dogs, 6 oz canister, DISTRIBUTED BY: THE IAMS COMPANY, SUBSIDIARY OF THE PROCTER & GAMBLE CINCINNATI, OHIO, 45202 UPC 0 19014 61043 3, Lot # 2325419715A 3103, Best  ...
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Class III The firm was notified via consumer complaints that the product contains mold. Procter & Gamble Co
Veterinary Iams Shakeables Un-baa-lievable With Lamb for Dogs, 6 oz canister, DISTRIBUTED BY: THE IAMS COMPANY, SUBSIDIARY OF THE PROCTER & GAMBLE CINCINNATI, OHIO, 45202 UPC 0 19014 00024 1, Lot # 2338419715A 3102, Best By Date May 3, 2014 Class III The firm was notified via consumer complaints that the product contains mold. Procter & Gamble Co
Biologics Bone IBM1259119006; IBM1259119007; IBM1259119008; IBM1259119009; IBM1259119010; IBM1259119011; IBM1259119012; IBM1259119013; IBM1259119014; IBM1259119015; IBM1259119016; IBM1259119017; IBM1259119018; IBM1259119019; IBM1259119020 Class III Human tissue allografts were processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P. International Biologics LLC
Devices Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Manufacturer Part Number: 250-070-403 Class II The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C. Stryker Endoscopy
Devices Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Manufacturer Part Number: 250-070-403 Class II The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C. Stryker Endoscopy
Devices Stryker Irrigator Reusable Tips: 10mm X 32cm Pool Suction Tip, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Manufacturer Part Number: 250-070-404. Class II The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C. Stryker Endoscopy
Devices Stryker Irrigator Reusable Tips: 5mm X 32cm Tip Hydrodissection Tip, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Manufacturer Part Number:250-070-407 Class II The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C. Stryker Endoscopy
Devices Stryker Irrigator Reusable Tips: 5mm X 45cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Manufacturer Part Number: 250-070-408. Class II The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C. Stryker Endoscopy
Devices Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip , Non-Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Manufacturer Part Number: 250-070-409 Class II The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C. Stryker Endoscopy
Devices Stryker Irrigator Reusable Tips: 5mm X 24cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Manufacturer Part Number: 250-070-411 Class II The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C. Stryker Endoscopy
Devices Stryker Irrigator Reusable Tips: 5mm X 32cm Aspiration Needle Tip. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Manufacturer Part Number: 250-070-437 Class II The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C. Stryker Endoscopy
Devices Stryker Irrigator Reusable Tips: 2mm X 32cm Regular Tip with 1 Hole, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Manufacturer Part Number: 250-070-471 Class II The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C. Stryker Endoscopy
Devices Stryker Irrigator Reusable Tips: 2mm X 32cm Regular Tip with 2 Hole, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Manufacturer Part Number: 250-070-472 Class II The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C. Stryker Endoscopy
Devices Stryker Irrigator Reusable Tips: 2mm X 34cm Regular Tip with No Hole, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Manufacturer Part Number: 250-070-473 Class II The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C. Stryker Endoscopy
Devices Stryker Irrigator Reusable Tips: 5mm X 28cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Manufacturer Part Number: 250-070-482 Class II The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C. Stryker Endoscopy
Devices Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Manufacturer Part Number: 250-070-483 Class II The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C. Stryker Endoscopy
Devices Stryker Irrigator Reusable Tips: 10mm X 32cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Manufacturer Part Number: 250-070-484 Class II The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C. Stryker Endoscopy
Devices Stryker Irrigator Reusable Tips: 5mm X 32cm Hydrodissection Tip, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Manufacturer Part Number: 250-070-487 Class II The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C. Stryker Endoscopy
Devices Stryker Irrigator Reusable Tips: 5mm X 45cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Manufacturer Part Number: 250-070-488 Class II The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C. Stryker Endoscopy
Devices Stryker Irrigator Reusable Tips: Vented Tip, 5mm X 45cm Non-Reflective with 30° Downward Bend At Proximal End. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Manufacturer Part Number: 250-070-488s2 Class II The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C. Stryker Endoscopy
Devices Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip with No Holes, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Manufacturer Part Number: 250-070-489 Class II The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C. Stryker Endoscopy
Devices Stryker Irrigator Reusable Tips: 3mm X 32cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Manufacturer Part Number: 250-070-490 Class II The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C. Stryker Endoscopy
Devices Stryker Irrigator Reusable Tips: 3mm X 32cm Regular Tip, Non-Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Manufacturer Part Number: 250-070-491 Class II The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123°C , instead of the correct 132-133°C. Stryker Endoscopy
Devices A) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set, 4.8", Vol. 0.6 mL, Male Luer Lock Adapter, Single use only; B) Product Code 2N1206: Non-DEHP I.V. Catheter Extension Set, 5.7", Vol. 0.7 mL, Male Luer Lock Adapter with Retractable Collar, Single use only Product Usage: These devices are indicated for use with a vascular access device for administration and withdrawal of fluids. A) Product Code 2N1191: Lots R12J06052, R12J08041, R12K06134, R12K08015, R12K26108, R12K27155; B) Product Code 2N1206: Lots R12J08124, R12J24121, R12K01119, R12K23089, R12K24053, R12K22016 Class II Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties. Baxter Healthcare Corp.
Devices A) Product Code 2N3371: Non-DEHP Y-Type Catheter Extension Set, 5.7", Vol. 0.8 mL, 2 Injection Sites, Male Luer Lock Adapter, Single use only Product Usage: This device is indicated for use in blood sampling and the administration of solutions. The InterLink Injection Site feature is intended to eliminate accidental needle sticks when used in conjunction with an InterLink Cannula as part of an I.V. needless access system. A) Product Code 2N3371: Lots R12H23076, R12H30097, R12I0707, R12I08059, R12I25046, R12I2607, R12J11052, R12J12068, R12J13058R12K17057, R12L10084, R13A12057 Class II Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties. Baxter Healthcare Corp.
Devices A) Product Code 2N8220: Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 7.7", Vol. 1.10 mL, Luer Activated Valve for IV Access, Male Luer Lock Adapter, 2) Medium Catheter Stabilization Device, and 3) Foam Tape Strips; B) Product Code 2N8221: Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 7.1", Vol. 0.85 mL, Injection Site Male Luer Lock Adapter with Retractable Collar, 2) Medium Catheter Stabilization Device, and 3) Foam Tape Strips; C) Product Code 2N8222: Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 8.2", Vol. 0.57 mL, Luer Activated Valve for IV Access, Male Luer Lock Adapter, 2) Medium Catheter Stabilization Device, and 3) Foam Tape Strips; D) Product Code 2N8223: Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 7.7", Vol. 0.40 mL, Injection Site Male Luer Lock Adapter, 2) Medium Catheter Stabilization Device, and 3) Foam Tape Strips; E) Product Code 6N8220: V-LINK Luer Activated Device with VITALSHIELD Protective Coating Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 7.6", Vol. 1.0 mL, Catheter Extension Set, Luer Activated Device with Silver for IV Access, Male Luer Lock Adapter with Retractable Collar, 2) Medium Catheter Stabilization Device, and 3) Foam Tape Strips; F) Product Code 6N8222: V-LINK Luer Activated Device with VITALSHIELD Protective Coating Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 8.2", Vol. 0.5 mL, Catheter Extension Set, Luer Activated Device with Silver for IV Access, Male Luer Lock Adapter, 2) Medium Catheter Stabilization Device, and 3) Foam Tape Strips Product Usage: The IV extension tubing kits are intended to provide users with a ready to use set up for the administration and withdrawal of fluids avoiding the need to acquire/assemble components from various manufacturers. The IV extension tubing sets are indicated for use with a vascular access device for administration and withdrawal of fluids. A) Product Code 2N8220: Lots R12J05070; B) Product Code 2N8221: Lots R12J20046, R12J22042; C) Product Code 2N8222: Lots R12L07031; D) Product Code 2N8223: Lots R12L06074, R12K02083; E) Product Code 6N8220: Lots R12I01054, R12H25048, R12H27192, R12J04057, R12J22109, R12L07049, R12L08088; F) Product Code 6N8222: Lots R12J15046, R12J23115 Class II Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties. Baxter Healthcare Corp.
Devices A) Product Code 2N8371: Non-DEHP Y-Type Catheter Extension Set Kit, 6.0", Vol. 1.0 mL, 2 Luer Activated Valves, Male Luer Lock Adapter, Single use only Product Usage: The IV extension tubing kits are intended to provide users with a ready to use set up for the administration and withdrawal of fluids avoiding the need to acquire/assemble components from various manufacturers. The IV extension tubing sets are indicated for use with a vascular access device for administration and withdrawal of fluids. A) Product Code 2N8371: Lots R12E03108, R12H27085, R12H28075, R12H29057, R12H30139, R12103092, R12104058, R12105022, R12106061, R12110113, R12119056, R12120112, R12121151, R12122050, R12124106, R12124130, R12J25045, R12K03057, R12K19046, R12K21034, R12K21083, R12L05118, R12L08054, R12L18111, R12Ll9101, R13A08063, R13A08147, Rl3A09137, R13A10101, R13A14129, R13A15050 Class II Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties. Baxter Healthcare Corp.
Devices Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels. .MICroSTREP panels are designed for use in determining antimicrobial agent susceptibility of aerobic nonenterococcal streptococci (including Streptococcus pneumoniae) and Haemophilus spp. All lots within expiration: Lot numbers: 2013-02-24 2013-03-05 2013-03-06 2013-04-03 2013-04-04 2013-04-19 2013-05-01 2013-05-10 2013-05-18 2013-05-21 2013-06-07 2013-06-18 2013-06-25 2013-07-27 2013-08-10 2013-08-23 2013-09-11 2013-09-14 2013-09-28 2013-10-02 2013-11-01 2013-11-02 2013-11-15 2013-11-29 2013-12-07 2013-12-12 2013-12-17 2014-01-04 2014-01-09 2014-01-15 2014-02-01 2014-02-13. Class II Customer complaint investigation confirmed the issue of false skipped wells and false susceptible misreads with A. agalactiae affecting multiple antimicrobial agents on MicroScan Microbiology Systems. Siemens Healthcare Diagnostics, Inc.
Devices Wallace Sure-Pro/ Sure-Pro Ultra Embryo Replacement Catheters (with ultrasound) Product Code: PE623 Sure-Pro® Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra® Embryo Replacement Catheters have the added benefit of being visible under ultrasound. These products can be used in either a one- stage or two-stage procedure. In the one-stage procedure, the clinician pushes the inner catheter through the outer sheath and loads the embryo prior to performing the embryo transfer into the uterus. In the two-stage procedure, the clinician places the outer sheath through the cervical canal into the uterus, then loads the embryo in the inner catheter, and advances the inner catheter through the outer sheath to perform the embryo transfer into the uterus. Lot Codes: 2000099 2044001 2044005 2117201 2117202 2120953 2138832 2138833 2161554 2304181 2304182 2304199 2305239 2305240 2308138 2313278 2332537 2336956 2336957 2341409 2341410 2344790 Class II Unable to pass catheter through outer sheath during embryo transfer Smiths Medical ASD, Inc.
Devices Wallace Sure-Pro Ultra® Embryo Replacement Catheter with Obturator Product Code: PEB623 Sure-Pro® Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra® Embryo Replacement Catheters have the added benefit of being visible under ultrasound. These products can be used in either a one- stage or two-stage procedure. In the one-stage procedure, the clinician pushes the inner catheter through the outer sheath and loads the embryo prior to performing the embryo transfer into the uterus. In the two-stage procedure, the clinician places the outer sheath through the cervical canal into the uterus, then loads the embryo in the inner catheter, and advances the inner catheter through the outer sheath to perform the embryo transfer into the uterus. Lot Codes: 2000101 2044006 2044008 2044009 2065654 2117203 2117204 2120950 2138835 2152580 2152582 2156663 2165851 2165852 2170920 2170926 2295309 2304187 2304192 2304193 2304194 2304196 2304197 2304198 2305241 2305243 2313279 2324539 2327973 2327974 2336959 2341411 2341412 2341414 2341415 2341416 2341420 Class II Unable to pass catheter through outer sheath during embryo transfer Smiths Medical ASD, Inc.
Devices Wallace Sure-Pro Ultra® Embryo Replacement Catheter with Stylet Product Code:PES623 Sure-Pro® Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra® Embryo Replacement Catheters have the added benefit of being visible under ultrasound. These products can be used in either a one- stage or two-stage procedure. In the one-stage procedure, the clinician pushes the inner catheter through the outer sheath and loads the embryo prior to performing the embryo transfer into the uterus. In the two-stage procedure, the clinician places the outer sheath through the cervical canal into the uterus, then loads the embryo in the inner catheter, and advances the inner catheter through the outer sheath to perform the embryo transfer into the uterus. Lot Codes: 2000102 2138834 2143444 2147484 2152583 2152584 2304183 2305244 2336960 Class II Unable to pass catheter through outer sheath during embryo transfer Smiths Medical ASD, Inc.
Devices Wallace Sure-Pro® Two Stage Embryo Replacement Catheter with Obturator PPB623 Sure-Pro® Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra® Embryo Replacement Catheters have the added benefit of being visible under ultrasound. These products can be used in either a one- stage or two-stage procedure. In the one-stage procedure, the clinician pushes the inner catheter through the outer sheath and loads the embryo prior to performing the embryo transfer into the uterus. In the two-stage procedure, the clinician places the outer sheath through the cervical canal into the uterus, then loads the embryo in the inner catheter, and advances the inner catheter through the outer sheath to perform the embryo transfer into the uterus. Lot codes: 2000100 2025750 2044018 2044019 2065655 2120952 2152589 2152590 2156664 2156665 2170927 2295308 2305235 2305236 2305237 2305238 2308139 2308141 2313280 2313281 2320238 2324603 2336961 2341418 2359095 2363587 2363588 2363589 2363592 2363593 2363594 2363595 2363596 2363597 2363598 Class II Unable to pass catheter through outer sheath during embryo transfer Smiths Medical ASD, Inc.
Devices Wallace Sure-Pro® Two Stage Embryo Replacement Catheter for difficult transfer with Stylet PPS623 Sure-Pro® Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra® Embryo Replacement Catheters have the added benefit of being visible under ultrasound. These products can be used in either a one- stage or two-stage procedure. In the one-stage procedure, the clinician pushes the inner catheter through the outer sheath and loads the embryo prior to performing the embryo transfer into the uterus. In the two-stage procedure, the clinician places the outer sheath through the cervical canal into the uterus, then loads the embryo in the inner catheter, and advances the inner catheter through the outer sheath to perform the embryo transfer into the uterus. Lot Code: 2000103, 2025752, 2161556, 2165854, 2170929, 2304190, 2363603 Class II Unable to pass catheter through outer sheath during embryo transfer Smiths Medical ASD, Inc.
Devices Wallace Sure-Pro® Single Stage Embryo Replacement Catheter Product Code: PP623 Sure-Pro® Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra® Embryo Replacement Catheters have the added benefit of being visible under ultrasound. These products can be used in either a one- stage or two-stage procedure. In the one-stage procedure, the clinician pushes the inner catheter through the outer sheath and loads the embryo prior to performing the embryo transfer into the uterus. In the two-stage procedure, the clinician places the outer sheath through the cervical canal into the uterus, then loads the embryo in the inner catheter, and advances the inner catheter through the outer sheath to perform the embryo transfer into the uterus. Lot codes: 2000098 2025748 2041152 2332539 2350024 Class II Unable to pass catheter through outer sheath during embryo transfer Smiths Medical ASD, Inc.
Drugs Liothyronine Sodium Tablets, USP, 5 mcg Rx ONLY, 100 count bottle, Distributed by: PaddockLaboratories, Inc., Minneapolis, MN 55427, NDC 0574-0220-01, 12K714 exp. 12/13, 12K715 exp. 12/13 Class III Failed Impurities/Degradation Specifications: Perrigo is conducting a wholesale level recall of two batches of this product due to an out of specification impurity result during three month stability testing. L. Perrigo Co.
Devices Presource PBDS, Gyn Laparoscopy Kit, Circulator Catalog Number: PB24LSNPC01; Lots: 152737, 159630, 168459, 176674, 187217, 197319, 840618 Class I Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow. Cardinal Health, Medical Products & Services
Devices A) Presource PBDS, Lap Chole, Kit, Clean Up; B) Presource PBDS, Greenwood LeFlore Hosp, Lap Chole, Kit A) Catalog Number: PG24LCGWG02; Lots: 153502, 162892, 170494, 180482, , 88701, 193548, 198163, 206986; B) Catalog Number: PG24LCGWG; Lots:153502, 162892, 170494, 180482, 188701, 193548, 198163, 206986 Class I Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow. Cardinal Health, Medical Products & Services
Devices Presource PBDS, General Laparoscopy, Kit, Circulator Catalog Number: PG24LGNPC01; Lots: 147492, 152554, 160275, 165822, 173745, 180700, 186904, 195042, 205901, 836989 Class I Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow. Cardinal Health, Medical Products & Services
Devices Presource PBDS, Major Abdominal, Kit, Circulator Catalog Number: PG24MANPC01; Lots: 840143, 857320, 871000, 882315, 900599, 928133, 942238, 952387, 964048 Class I Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow. Cardinal Health, Medical Products & Services
Devices Presource PBDS, Knee Arthroscopy, Kit, Circulator Catalog Number: PO24AKNPC01; Lots: 851288, 877594, 901672, 917786, 948443, 972424 Class I Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow. Cardinal Health, Medical Products & Services
Devices Presource PBDS, Extremity, Kit, Circulator Catalog Number: PO24EXNPD01; Lots: 852429, 868825, 883022, 896400, 914524, 929984, 941696, 954317 Class I Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow. Cardinal Health, Medical Products & Services
Devices Presource PBDS, Hand, Kit, Circulator Catalog Number: PO24HKGWG01; Lots: 856515, 875680, 894983, 905021, 929987, 932368, 946822, 954543, 968547 Class I Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow. Cardinal Health, Medical Products & Services
Devices Presource PBDS, Shoulder Arthroscopy, Kit, Circulator Catalog Number: PO24SAGWF01; Lots: 847129, 877843, 905183, 931801, 935180, 946651, 957422, 969585 Class I Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow. Cardinal Health, Medical Products & Services
Devices Presource PBDS, Shoulder Procedure, Kit, Circulator Catalog Number: PO24SHNPC01; Lots: 843685, 864636, 875004, 893118, 901720, 924132, 934399, 959120, 968668 Class I Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow. Cardinal Health, Medical Products & Services
Devices Presource PBDS, Total Hip, Kit, Circulator Catalog Number: PO24THGWG01; Lots: 966051, 970753 Class I Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow. Cardinal Health, Medical Products & Services
Devices Presource PBDS, Total Joint, Kit, Circulator Catalog Number: PO24TJNPC01; Lots: 843134, 851291, 875033, 893475, 911751, 914529, 928726, 948543, 968125, Class I Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow. Cardinal Health, Medical Products & Services
Devices Presource PBDS, Total Knee, Kit, Circulator Catalog Number: PO24TKGWE01; Lots: 828654, 851596, 872322, 879459, 885132, 905305, 920462, 934298, 946652, 959208 Class I Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow. Cardinal Health, Medical Products & Services
Devices Presource PBDS, Beaufort Memorial Hospital, Anesthesia Circuit, Kit Catalog Number:PZ23ANBUG; Lot: 200710 Class I Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow. Cardinal Health, Medical Products & Services
Devices Presource PBDS, Knee Arthroscopy, Kit, Circulator Catalog Number: PO24KAGWE01; Lots: 839276, 851503, 884374, 905171, 930617, 946381, 952446, 959782 Class I Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow. Cardinal Health, Medical Products & Services
Biologics Rho(D) Immune Globulin (Human) RVP166A1, RVP167A1, RVP164A1 Class III Rh Immune Globulin, lacking assurance of proper temperature maintenance during transit, was distributed. Ortho Clinical Diagnostics Inc
Biologics Cornea 04871302 Class II Human corneal allograft was processed in a manner that could cause contamination or cross-contamination during processing, and well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P. North Carolina Eye Bank, Inc. (The)
Devices Synthes Radial Head Prosthesis: Trial Radial Head Elbow joint prosthesis: Synthes Radial Head Prosthesis System is a two-piece modular system comprised of titanium alloy stem and cobalt chrome components with an integral screw and side-loading application to allow in-situ assembly. All Lots of Part Numbers: 03.402.018, 03.402.020, 03.402.022, 03.402.024, 03.402.026, 03.402.028, 03.402.218, 03.402.220, 03.402.222, 03.402.224, 03.402.226, 03.402.228, 03.402.418, 03.402.420, 03.402.422, 03.402.424, 03.402.426, 03.402.428, 03.402.618, 03.402.620, 03.402.622, 03.402.624, 03.402.626, and 03.402.628. Class II The Trial Head may come loose from the implant stem during manipulation of the arm during surgery. To date, no adverse events have been reported related to this issue and this recall is not being initiated as a result of adverse events. Synthes USA HQ, Inc.
Biologics MicroCel 500 Buffer Chamber Distributed by Siemens Healthcare Diagnostics, 725 Potter Street, Berkeley, CA 94710 Catalog number 10312319/VG 42115 Class II MicroCel 500 and MicroCel 300 buffer chambers, with the potential to leak buffer and could cause electrical arcing posing a hazard to the operator, were distributed. Siemens Healthcare Diagnostics Inc.
Biologics MicroCel 300 Buffer Chamber Distributed by Siemens Healthcare Diagnostics, 725 Potter Street, Berkeley, CA 94710 Catalog number 10319937/ VG 42044 Class II MicroCel 500 and MicroCel 300 buffer chambers, with the potential to leak buffer and could cause electrical arcing posing a hazard to the operator, were distributed. Siemens Healthcare Diagnostics Inc.
Biologics Bone 0090330081; 0090330080 Class III HCT/P allografts, mislabeled with an incorrect expiration date, were distributed. University Of Miami Miller School of Medicine Tissue Bank
Biologics Red Blood Cells Leukocytes Reduced 003LH34364 Class II Blood product, misbranded as Jkb negative, and subsequently determined to be JKb positive, was distributed. The American National Red Cross - Southern Region
Devices FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only. Use only with FreeStyle InsuLinx test strips. Abbott Diabetes Care, Inc. 1360 South Loop Road Alameda, CA 94502 USA The FreeStyle InsuLinx Blood Glucose Test Strips are for use with the FreeStyle InsuLinx Blood Glucose Meter to quantitatively measure glucose in capillary whole blood samples drawn from the fingertip. Part Numbers: 71142-70 71143-70 71145-70 71150-70: All serial and lot numbers. Class I AT rare, extremely high glucose levels (1024 mg/dL and above), the FreeStyle InsuLinx Blood Glucose Meter may provide an inaccurate reading. Abbott Diabetes Care, Inc.
Devices Cypress Medical Products LLC, MediChoice Umbilical cord clamp, sterile; single use; Distributed by Owens & Minor, Mechanicsville, VA. The product is used to clamp the umbilical cord after childbirth. Part Number: 1773088101; Lot Number CYB03-11; 1 per pouch; 100 pouches per box. Class II Cypress Medical Products LLC is voluntarily recalling one lot of the Owens and Minor (O&M) Umbilical Cord Clamps because recent complaints indicate the clamps are breaking upon use. The product may not perform as intended. Cypress Medical Products LLC
Devices DePuy Mitek Tissue Liberator -Blade Up Catalog Number: 214623 The Reusable Arthroscopy Instruments are reusable, non-powered surgical instruments used during arthroscopic surgery of any joint except the spine. Lot number:13A01 Class II Labeled incorrectly as a Blade Up configuration instead of a Blade Down configuration. DePuy Mitek, Inc., a Johnson & Johnson Co.
Veterinary Lloyd Thyro-Tabs, levothyroxine sodium tablets, USP, 0.1mg, packaged in 120-ct bottles (NDC 11789-251-10), Lloyd, Shenandoah, IA. Lot: VKE29211, Exp date: Jul-13 Class III The product Lot number and/or Expiration Date may be illegible or may be erased. Lloyd Inc. of Iowa
Veterinary Lloyd Thyro-Tabs, levothyroxine sodium tablets, USP, 0.2 mg, packaged in 120-ct bottles (NDC 11789-252-10), Lloyd, Shenandoah, IA. Lot:: KB33411, Exp date: Sep-13; Lot: KB33411A, Exp date: Sep-13 Class III The product Lot number and/or Expiration Date may be illegible or may be erased. Lloyd Inc. of Iowa
Veterinary Lloyd Thyro-Tabs, levothyroxine sodium tablets, USP, 0.3 mg, packaged in 120-ct bottles (NDC 11789-253-10), Lloyd, Shenandoah, IA. Lot:: KA32111, Exp date: Aug-13; Lot: KA32111A, Exp date: Aug-13 Class III The product Lot number and/or Expiration Date may be illegible or may be erased. Lloyd Inc. of Iowa
Veterinary Lloyd Thyro-Tabs, levothyroxine sodium tablets, USP, 0.4 mg, packaged in 120-ct bottles (NDC 11789-254-10), Lloyd, Shenandoah, IA. Lot:: KB33611, Exp date: Sep-13; Lot: KB33611A, Exp date: Sep-13 Class III The product Lot number and/or Expiration Date may be illegible or may be erased. Lloyd Inc. of Iowa
Veterinary Lloyd Thyro-Tabs, levothyroxine sodium tablets, USP, 0.6 mg, packaged in 120-ct bottles (NDC 11789-256-10), Lloyd, Shenandoah, IA. Lot:: KA32511, Exp date: Aug-13 Class III The product Lot number and/or Expiration Date may be illegible or may be erased. Lloyd Inc. of Iowa
Veterinary Lloyd Thyro-Tabs, levothyroxine sodium tablets, USP, 0.5 mg, packaged in 120-ct bottles (NDC 11789-255-10), Lloyd, Shenandoah, IA. Lot:: VKA31311, Exp date: Aug-13 Class III The product Lot number and/or Expiration Date may be illegible or may be erased. Lloyd Inc. of Iowa
Veterinary Lloyd Thyro-Tabs, levothyroxine sodium tablets, USP, 0.7 mg, packaged in 120-ct bottles (NDC 11789-257-10), Lloyd, Shenandoah, IA. Lot:: KD33611, Exp date: Sep-13 and Lot:: KD33611A, Exp date: Sep-13 Class III The product Lot number and/or Expiration Date may be illegible or may be erased. Lloyd Inc. of Iowa
Veterinary Lloyd Thyro-Tabs, levothyroxine sodium tablets, USP, 0.8 mg, packaged in 120-ct bottles (NDC 11789-258-10), Lloyd, Shenandoah, IA. Lot:: VKB30711, Exp date: Aug-13 and Lot:: VKB02412, Exp date: Nov-13 Class III The product Lot number and/or Expiration Date may be illegible or may be erased. Lloyd Inc. of Iowa
Veterinary Lloyd Thyro-Tabs, levothyroxine sodium tablets, USP, 1.0 mg, packaged in 120-ct bottles (NDC 11789-268-10), Lloyd, Shenandoah, IA. Lot:: VKF33611, Exp date: Sep-13 and Lot:: VKF33611A, Exp date: Sep-13 Class III The product Lot number and/or Expiration Date may be illegible or may be erased. Lloyd Inc. of Iowa
Devices Olympus SurgMaster UES-40 electrosurgical unit ("UES-40") Product Usage: Designed for use in a medical facility under the supervision of a trained physician. It has been designed for general (open) and endoscopic surgery including urology, gynecology, respiratory and gastroenterology in conjunction with Olympus designed electrosurgical accessories, endoscopes (fiberscopes, videoscopes and rigid scopes) applicable for electrosurgery (cutting and coagulation), light sources and other ancillary equipment. Model UES-40, all serial numbers prior to 7925334 that have not been upgraded. Class II Olympus initiated a software upgrade and enhancement in 2009 and completed the action in 2010. The upgrade and enhancement were initiated due to complaints of overheating, smoke vapors and failure to operate associated with the Olympus SurgMaster electrosurgical unit, model UES-40 ("UES-40") when used in conjunction with the Olympus WA22557C electrode. The complaint investigations revealed that some users were exceeding the maximum output time beyond the timeframes specified in the labeling. Exceeding the maximum output time can cause the UES-40 to overheat thereby causing the unit to stop working and produce smoke vapors. Olympus America Inc.
Devices Codman(R) Collins Radioparent Sternal Blade Nylon,4 3/4" (121 mm) long, 3" (76 mm) wide, 1 1/2" (38 mm) deep, REF 50-8081 sternum retractor 244576, 244582, 244584, 268916, 268920, 276513, 276514, 296136, 296139, 296141, 296153, 296155, 296156, 296157, 296160 Class II There is a possibility that the Collins Radioparent Sternal Blades Nylon may break during use. Symmetry Medical/SSI
Devices ExoShape Soft Tissue Fastener 12 mm x 30 mm REF 1101-00-1230. For use in the fixation of ligaments, tendons or soft tissue grafts to bone. Lot No. 113011-002 Class II Expiration date on the patient label and date on the product carton were not the same. Medshape Solutions, INC.
Drugs Plavix 75 mg, 30 count bottle, NDC (54868-4070-0), Rx only, Manufactured by Bristol-Meyers Squibb, Bridgewater, NJ 08807, Distributed by Physicians Total Care, Tulsa, OK 74146. Lot # 67JV Exp 08/13 Class III Chemical Contamination: Uncharacteristic moldy odor due to presence of 2,4,6-tribromoanisole (TBA). Physicians Total Care, Inc.
Food Maple View Farm Ice Cream, Carolina Crunch, One Fluid Pint (473ml), Maple View Farm Ice Cream Co., LLC, Hillsborough, NC 27278. Individual containers are not coded. Product distributed from Sept. 5, 2012 and April 24, 2013. Class I Undeclared allergens: Peanuts, Almond and Soy (soy lecithin and soybean oil). Maple View Ice Cream
Food Maple View Farm Ice Cream, Cookies and Cream, One Fluid Pint (473ml), Maple View Farm Ice Cream Co., LLC, Hillsborough, NC 27278. Individual containers are not coded. Product distributed from Sept. 5, 2012 and April 24, 2013. Class II Undeclared allergens: Wheat and Soy (soybean oil). Maple View Ice Cream
Food Maple View Farm Ice Cream, Cookie Dough, One Fluid Pint (473ml), Maple View Farm Ice Cream Co., LLC, Hillsborough, NC 27278. Individual containers are not coded. Product distributed from Sept. 5, 2012 and April 24, 2013. Class II Undeclared allergens: Wheat and Soy (soy lecithin). Maple View Ice Cream
Food Winn Dixie Organic 100% Apple Juice from concentrate with added ingredients, 64-fl oz Lot # 3690230152 exp 1/15/2014 Lot # 3690230292 exp 1/29/2014 Lot # 3690230582 exp 2/27/2014 Lot # 3690230702 exp 3/11/2014 Lot # 3690230702 exp 3/12/2014 Lot # 3690230842 exp 3/25/2014 Class II The product is being recalled as a precaution because it could have levels of "patulin" that exceeds FDA limits. Winn-Dixie Logistics, Inc.
Drugs Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12 Lot 05-585-EV Exp. 05/13 Class II Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. Hospira Inc.
Drugs Furosemide Injection, USP, 40 mg/4mL (10 mg/mL), 4 ml Single-Dose Vial, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-6102-04 Lot 20-564-DK Exp. 02/14 Class II Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. Hospira Inc.
Drugs QUELICIN (succinylcholine chloride) Injection, USP, 200 mg (20 mg/mL) 10 mL, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, , NDC 0409-6629-02 Lot 21-480-EV Exp.12/13 Class II Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. Hospira Inc.
Drugs Sodium Acetate Injection, USP, 40 mEq/20 ml (2 mEq/mL) 20 mL Single-Dose Fliptop, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-7299-73 Lot 23-320-DK and 23-321-DK Exp. 11/14 Class II Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. Hospira Inc.
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