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U.S. Department of Health and Human Services

Enforcement Report - Week of August 28, 2013

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Platelets Pheresis Leukocytes Reduced 103081478 Class II Blood product, with positive bacterial detection testing, was distributed. Blood Systems, Inc.
Biologics Platelets Pheresis Leukocytes Reduced Irradiated 103697958 Class II Blood product, with positive bacterial detection testing, was distributed. Blood Systems, Inc.
Biologics Platelets Pheresis Leukocytes Reduced 108021563(Part A); 108021563(Part B) Class II Blood Products, which were contaminated with Corynebacterium species, were distributed. Blood Systems, Inc.
Biologics Red Blood Cells Leukocytes Reduced 108012740(Part A) Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Blood Systems, Inc.
Biologics Red Blood Cells Leukocytes Reduced 108024925(Part A) Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Blood Systems, Inc.
Biologics Source Plasma 0230045965, 0230046276 Class III Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Biomat USA, Inc.
Biologics Source Plasma 0230005934 0230006594 0230007010 0230007704 0230008026 0230008774 0230009105 0230009716 0230010053 0230010737 0230011090 0230011783 0230012190 0230012866 0230013242 0230013874 0230014166 0230014835 0230015137 0230015838 0230016157 0230016877 0230017197 0230017916 0230018140 0230018821 0230019107 0230019832 0230020173 0230020889 0230021231 0230022001 0230022295 0230023406 0230023699 0230024368 0230024663 Class III Blood products, which were collected from a donor with a history of living with someone who is HIV positive, were distributed. Biomat USA, Inc.
Biologics Red Blood Cells Leukocytes Reduced 4067666 Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. HemaCare Corporation
Biologics Red Blood Cells Leukocytes Reduced 007GE26161 Class II Blood product, collected from a donor who gave history which warranted deferral, was distributed. American National Red Cross (The)
Biologics Source Plasma 0480908143; 0480907970; 0480907276; 0480906431; 0480906175 Class II Blood products, collected from a donor who did not have a complete physical examination, were distributed. CSL Plasma Inc
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced FZ65185 Class II Blood product, which failed to meet the minimum specification for product volume, was distributed. Tri-counties Blood Bank
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced GW79769; GW79769 Class III Blood products, were not quarantined or measured to confirm an acceptable RBC volume, were distributed. Tri-counties Blood Bank
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced FZ66520; FZ66520 Class III Blood products, quality control and distribution of products that did not meet specifications, were distributed. Tri-counties Blood Bank
Biologics Cryoprecipitated AHF, Pooled LF38077; LF38078; LF38079; LF38080; LF38081; LF38082; LF38084; LF38085 Class III Blood products, which were not frozen within 1 hour of production, were distributed. Tri-counties Blood Bank
Biologics Platelets Pheresis Leukocytes Reduced Irradiated GW81381 Class III Blood product, during irradiation process was out of storage greater than 30 minutes, was distributed. Tri-counties Blood Bank
Biologics Cryoprecipitated AHF 2109548 Class III Blood product was not frozen in required time, was distributed. Community Blood Centers of South Florida, Inc.
Biologics Source Plasma 2040055458, 2040053823, 2040052644 Class II Blood products, collected from a donor who did not have a complete physical examination, were distributed. PlasmaCare Inc
Biologics Platelets Pheresis Leukocytes Reduced Irradiated GS89507;GS90434;GS90437;GS90439;GS90441;GS90445;GS88058;GS90444;GS90446 Class III Blood products, for which storage condition was outside the acceptable range, were distributed. Blood Bank Of San Bernardino and Riverside Counties
Biologics Platelets Pheresis Leukocytes Reduced GS89507;GS89508;GS89768;GS89768;GS90434;GS90435;GS88058;GS90435;GS90436;GS90436;GS90439;GS90440;GS88056;GS88056;GS88058;GS90437;GS90443;GS90446;GS90449;GS89768;GS90445;GS90445;GS90446;GS90451 Class III Blood products, for which storage condition was outside the acceptable range, were distributed. Blood Bank Of San Bernardino and Riverside Counties
Biologics Red Blood Cells Leukocytes Reduced 2819133; 2815693; 1696707 Class II Blood products, with a low volume, were distributed. Hoxworth Blood Center University of Cincinnati Medical Center
Biologics Fresh Frozen Plasma 2815693 Class II Blood products, with a low volume, were distributed. Hoxworth Blood Center University of Cincinnati Medical Center
Biologics Red Blood Cells KJ43504I; KJ43504II Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Southern California Permanente Medical Group Blood Donor Center
Biologics Red Blood Cells Leukocytes Reduced Irradiated GW82775; GW82775; GW82775; GW82775 Class III Blood products, not prepared in accordance with specifications, were distributed. Blood Bank of San Bernardino and Riverside Counties
Drugs IRINOTECAN HYDROCHLORIDE INJECTION, 40 mg/2 mL (20 mg/mL), 2 mL Single Dose Vial, Rx only, Manufactured for: APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-193-02, UPC 3 63323 19302 7. Lot #: 872CZ00101, Exp 12/13 Class II Crystallization: Active pharmaceutical ingredient is precipitating in product solution. Fresenius Kabi USA LLC (FK USA)
Food NuGo Free Dark Chocolate Trail Mix Bar, 1.59 oz (45g) Non-Dairy Best By date ending in 2012 and 2013 UPC code 691535453012 (box) UPC code 69153545301 (bar) Class I Product may contain undeclared milk product NuGo Nutrition HQ
Food NuGo Free Dark Chocolate Crunch, 1.59 oz (45g) Non-Dairy Best By date ending in 2012 and 2013 UPC code 69153545102 (box) UPC code 69153545101 (bar) Class I Product may contain undeclared milk product NuGo Nutrition HQ
Food NuGo Free Carrot Cake, 1.59 oz (45g) Non-Dairy Best By 2012 and 2013 UPC 69153545502 (box) UPC 69153545501 (bar) Class I Product may contain undeclared milk product NuGo Nutrition HQ
Food NuGo Dark Chocolate Chocolate Chip 1.59 oz (45g) Non-Dairy Best By date ending in 2012 and 2013 UPC 69153552102 (box) UPC 69153552101 (bar) Class I Product may contain undeclared milk product NuGo Nutrition HQ
Food NuGo Dark Mocha, 1.59 oz (45g) Non-Dairy Best By date ending in 2012 and 2013 UPC code 69153552302 (box) UPC code 69153552301 (bar) Class I Product may contain undeclared milk product NuGo Nutrition HQ
Food NuGo Dark Mint Chocolate Chip, 1.59 oz (45g) Non-Dairy Best By date ending in 2012 and 2013 UPC 69153552502 (box) UPC 69153552501 (bar) Class I Product may contain undeclared milk product NuGo Nutrition HQ
Food NuGo Dark Peanut Butter Cup, 1.59 oz (45g) Non-Dairy Best By date ending in 2012 and 2013 UPC 69153552702 (box) UPC 69153552701 (bar) Class I Product may contain undeclared milk product NuGo Nutrition HQ
Food NuGo Dark Pretzel 1.59 oz (45g) Non-Dairy Non-Dairy Best By date ending in 2012 and 2013 UPC 69153552902 (box) UPC 69153552901 (bar) Class I Product may contain undeclared milk product NuGo Nutrition HQ
Food NuGo Slim Crunchy Peanut Butter, 1.59 oz (45g) Non-Dairy Best By date ending in 2012 and 2013 UPC 69153520702 (box) UPC 69153520701 (bar) Class I Product may contain undeclared milk product NuGo Nutrition HQ
Food NuGo Slim Espresso, 1.59 oz (45g) Non-Dairy Best By date ending in 2012 and 2013 UPC 69153520902 (box) UPC 69153520901 (bar) Class I Product may contain undeclared milk product NuGo Nutrition HQ
Biologics Platelets Pheresis Leukocytes Reduced W001313200265 Class II Blood product, which did not meet the acceptable product specifications for release, was distributed. Department of Air Force - BB/HT
Biologics Blood and Blood Products for Reprocessing W071212065186 Class III Blood product, which did not meet the acceptable product specifications, was distributed. Medic Inc
Biologics Platelets Pheresis Leukocytes Reduced W044113009725 Class II Blood product, which did not meet the acceptable product specifications for release, was distributed LifeServe Blood Center
Biologics Platelets Pheresis Leukocytes Reduced W036813047271 Class II Blood product, which did not meet acceptable product specifications, was distributed. OneBlood / dba CBCF
Biologics Cryoprecipitated AHF W068513390157Z Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Inland Northwest Blood Center
Biologics Red Blood Cells Leukocytes Reduced W0685133202186; W068513390157Z Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Inland Northwest Blood Center
Biologics Blood and Blood Products for Reprocessing W0685133202186; W068513390157Z Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed Inland Northwest Blood Center
Biologics Platelets Pheresis Leukocytes Reduced W041912047393C- part 3 Class II Blood products, which did not meet acceptable product specifications, were distributed. Blood Systems, Inc.
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W041912047393C-part 1; W041912047393C-part 2 Class II Blood products, which did not meet acceptable product specifications, were distributed. Blood Systems, Inc.
Biologics Red Blood Cells W012012003060 Class II Blood product, collected from a donor who traveled to a malarial endemic area, was distributed. Department of Army US Army Blood Bank Center
Food Texas Wild UPC 51/60 BSO Shrimp Headless Shell-on IQF, Wild Caught, Product of the USA 20 # Net Weight, Galveston Shrimp Co., Galveston, TX 77550 UPC 27241-45551, lot number 379B Class II Foreign Material Galveston Shrimp Company, Inc.
Food Texas Wild UPC 41/50 BSO, Shrimp Headless Shell-on, IQF Wild Caught, Product of the USA 20# Net Weight, Galveston Shrimp Co., Galveston, Texas 77550 UPC 27241-72010, lot number 379B Class II Foreign Material Galveston Shrimp Company, Inc.
Food Texas Wild UPC 31/40 BSO, Shrimp Headless Shell-on, IQF, Wild Caught, Product of USA 20# Net Weight, Galveston Shrimp Co., Galveston, Texas 77550 UPC 27241-45530; 27241-45536 and 27241-45531 , lot number 379B Class II Foreign Material Galveston Shrimp Company, Inc.
Food Texas Wild UPC, 26/30 BSO, Shrimp Headless Shell-on, IQF, Wild Caught, Product of USA, 20# Net Weight, Galveston Shrimp Co., Galveston, Texas 77550 UPC 27241-72005 lot number 379B Class II Foreign Material Galveston Shrimp Company, Inc.
Food Texas Wild UPC 16/25 BSO, Shrimp Headless Shell-on, IQF, Wild Caught, Product of USA, 20# Net Weight, Galveston Shrimp Co., Galveston, TX 77550 UPC 27241-45519 lot number 379B Class II Foreign Material Galveston Shrimp Company, Inc.
Food Texas Wild UPC, 16/20 BSO, Shrimp Headless Shell-on, IQF, Wild Caught, Product of USA, 20# Net Weight, Galveston Shrimp Co., Galveston, TX 77550 UPC 27241-45516 lot number 379B Class II Foreign Material Galveston Shrimp Company, Inc.
Food Texas Wild UPC, 16/20 WSO, Shrimp Headless Shell-on, IQF, Wild Caught, Product of USA 20# Net Weight, Galveston Shrimp Co., Galveston, TX 77550 UPC 27241-45416 lot number H143 Class II Foreign Material Galveston Shrimp Company, Inc.
Food Texas Wild UPC, 10/15 BSO, Shrimp Headless Shell-on, IQF, Wild Caught, Product of USA, 20# Net Weight, Galveston Shrimp Co., Galveston, TX 77550 UPC 27241-45512 and 27241-45510 lot number 379B Class II Foreign Material Galveston Shrimp Company, Inc.
Food Texas Wild UPC, 10/15 WSO, Shrimp Headless Shell-on, IQF, Wild Caught, Product of USA, 20# Net Weight, Galveston Shrimp Co., Galveston, TX 77550 UPC 27241-45410 and 27241-45412 lot number H143 Class II Foreign Material Galveston Shrimp Company, Inc.
Biologics Red Blood Cells Leukocytes Reduced Irradiated 2629093; Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Platelets Pooled Leukocytes Reduced 2928447; Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Blood and Blood Products for Reprocessing 16GY41376; Class III Blood product, collected from a donor in whom donor suitability was not adequately determined, was distributed. American National Red Cross
Biologics Red Blood Cells W036812440893; W036811187949; W036811102262; Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Platelets Pooled Leukocytes Reduced W036812843172; W036811804772; Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Fresh Frozen Plasma W036812440893; W036811187949; W036811102262; Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells Leukocytes Reduced W050912006948; Class III Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. HCSC-Blood Center
Biologics Fresh Frozen Plasma W050912006948; Class III Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. HCSC-Blood Center
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W050912005655; Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. HCSC-Blood Center
Biologics Red Blood Cells 2423919; Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Platelets Pooled Leukocytes Reduced 2918705; Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells Leukocytes Reduced LE33722; Class II Blood products, collected from an ineligible donor, were distributed BloodSource, Inc.
Biologics Blood and Blood Products for Reprocessing LE33722; Class II Blood products, collected from an ineligible donor, were distributed BloodSource, Inc.
Biologics Blood and Blood Products for Reprocessing W036813013386; W036812634195; Class III Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells Leukocytes Reduced W036813013386; W036812634195; W036812449727; Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Fresh Frozen Plasma W036812449727; Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Platelets Pooled Leukocytes Reduced W036812851617; W036812841109; Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells 2468490; Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Platelets Pooled Leukocytes Reduced W036811804654; Class II Blood products, collected from an ineligible donor, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells Leukocytes Reduced W036811057950; Class II Blood products, collected from an ineligible donor, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Blood and Blood Products for Reprocessing W036809182342; Class III Blood products, collected from an ineligible donor, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells W036809182342; 1700651; Class II Blood products, collected from an ineligible donor, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Fresh Frozen Plasma W036811057950; 1700651; Class II Blood products, collected from an ineligible donor, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Platelets 1700651; Class II Blood products, collected from an ineligible donor, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells W0410130357788; W041013044809A; W041013044904C; W0410130449068; W0410130499779; W041013049992B Class III Blood products, collected using an expired blood collection set, were distributed. Blood Systems Inc
Biologics Source Plasma TT0155293; TT0155522 Class II Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed. DCI Biologicals Temple Terrace, LLC
Biologics Red Blood Cells Leukocytes Reduced Irradiated W227012072941 Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Community Blood Center of Carolinas
Biologics Fresh Frozen Plasma W227012072941 Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Community Blood Center of Carolinas
Biologics Source Plasma BQ128259 Class II Blood product, collected from a donor who was previously deferred, was distributed. Plasma Biological Services
Biologics Platelets Irradiated 2030388 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Platelets 2236855 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Platelets Pooled Leukocytes Reduced Irradiated W036809820065 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Cryoprecipitated AHF 2236855; W036809257757 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells Leukocytes Reduced W036809257757 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Platelets Pooled Leukocytes Reduced W036810808509 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells 2030388; 2236855; 2326541; W036809346298; W036810169486; W036810134483 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Blood and Blood Products for Reprocessing W036809257757; W036809346298; W036810134483 Class III Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Fresh Frozen Plasma 2030388; 2326541; W036810271097 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Platelets Pooled Leukocytes Reduced W036810818581; W036812840236; W036812850369 Class II Blood products, collected from an ineligible donor, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Fresh Frozen Plasma W036810100975; W036812477893; W036812632589 Class II Blood products, collected from an ineligible donor, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells Leukocytes Reduced W036810100975; W036812373201 Class II Blood products, collected from an ineligible donor, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells W036811019911; W036812477893; W036812632589 Class II Blood products, collected from an ineligible donor, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Platelets Pooled Leukocytes Reduced Irradiated W036811804717; W036811808529; W036811826757 Class II Blood products, collected from an ineligible donor, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Blood and Blood Products for Reprocessing W036811019911; W036811164080; W036812373201 Class III Blood products, collected from an ineligible donor, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Platelets Pheresis Leukocytes Reduced W149513934295- part 1; W149513934295-part 2; W149513934326- part 1; W149513934326- part 2; W149513934326- part 3 Class II Blood products, which did not meet the acceptable product specifications, were distributed. Northern California Community Blood Bank
Devices 00597001101 Femur CR PRECOAT FEM COMP SIZE AML, Rx, Sterile; 00597001102 Femur CR PRECOAT FEM COMP SIZE AMR, Rx, Sterile; 00597001201 Femur CR PRECOAT FEM COMP SIZE BML, Rx, Sterile; 00597001202 Femur CR PRECOAT FEM COMP SIZE BMR, Rx, Sterile. Used in total knee arthroplasty and indicated for patients with severe pain. REF 00597001101, all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. Zimmer, Inc.
Devices 00597001131 Femur CR PRC SURF HDN FEM CO-NID AML, Rx, Sterile; 00597001132 Femur CR PRC SURF HDN FEM CO-NID AMR, Rx, Sterile; 00597001231 Femur CR PRC SURF HDN FEM CO-NID BML, Rx, Sterile; 00597001232 Femur CR PRC SURF HDN FEM CO-NID BMR, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. Zimmer, Inc.
Devices 00597201101 Femur CR POROUS FEM COMP SIZE AML Rx, Sterile; 00597201102 Femur CR POROUS FEM COMP SIZE AMR Rx, Sterile; 00597201201 Femur CR POROUS FEM COMP SIZE BML Rx, Sterile; 00597201202 Femur CR POROUS FEM COMP SIZE BMR Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. Zimmer, Inc.
Devices 65597201131 Femur CR POR FEM SURF HDN HATCP AML Rx, Sterile; 65597201132 Femur CR POR FEM SURF HDN HATCP AMR Rx, Sterile; 65597201231 Femur CR POR FEM SURF HDN HATCP BML Rx, Sterile; 65597201232 Femur CR POR FEM SURF HDN HATCP BMR Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. Zimmer, Inc.
Devices 00597201131 Femur CR POR SURF HDN FEM CO-NID AML Rx, Sterile; 00597201132 Femur CR POR SURF HDN FEM CO-NID AMR Rx, Sterile; 00597201231 Femur CR POR SURF HDN FEM CO-NID BML Rx, Sterile; 00597201232 Femur CR POR SURF HDN FEM CO-NID BMR Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. Zimmer, Inc.
Devices 65597201101 Femur CR POR FEM HATCP SIZE AML Rx, Sterile; 65597201102 Femur CR POR FEM HATCP SIZE AMR Rx, Sterile; 65597201201 Femur CR POR FEM HATCP SIZE BML Rx, Sterile; 65597201202 Femur CR POR FEM HATCP SIZE BMR Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. Zimmer, Inc.
Devices 00597601201 Femur CRA PRECOAT FEM COMP SIZE B/L Rx, Sterile; 00597601202 Femur CRA PRECOAT FEM COMP SIZE B/R Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. Zimmer, Inc.
Devices 00595601201 Femur CR-FLEX OPT FEM B-L Rx Sterile; 00595601202 Femur CR-FLEX OPT FEM B-R Rx Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. Zimmer, Inc.
Devices 00595001201 Femur CR-FLEX PCT FEM B-L Rx, Sterile; 00595001202 Femur CR-FLEX PCT FEM B-R Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. Zimmer, Inc.
Devices 00595201201 Femur CR-FLEX POR FEM B-L Rx, Sterile; 00595201202 Femur CR-FLEX POR FEM B-R Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. Zimmer, Inc.
Devices 65595201201 Femur CR-FLEX POR HATCP FEM B-L Rx, Sterile; 65595201202 Femur CR-FLEX POR HATCP FEM B-R Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. Zimmer, Inc.
Devices 00597001303 Femur CR PRC FEM COMP SIZE CML Rx, Sterile; 00597001304 Femur CR PRC FEM COMP SIZE CMR Rx, Sterile; 00597001403 Femur CR PRC FEM COMP SIZE DML Rx, Sterile; 00597001404 Femur CR PRC FEM COMP SIZE DMR Rx, Sterile; 00597001503 Femur CR PRC FEM COMP SIZE EML Rx, Sterile; 00597001504 Femur CR PRC FEM COMP SIZE EMR Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. Zimmer, Inc.
Devices 00597001333 Femur CR PRC SURF HDN FEM CO-NID CML Rx, Sterile; 00597001334 Femur CR PRC SURF HDN FEM CO-NID CMR Rx, Sterile; 00597001433 Femur CR PRC SURF HDN FEM CO-NID DML Rx, Sterile; 00597001434 Femur CR PRC SURF HDN FEM CO-NID DMR Rx, Sterile; 00597001533 Femur CR PRC SURF HDN FEM CO-NID EML Rx, Sterile; 00597001534 Femur CR PRC SURF HDN FEM CO-NID EMR Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. Zimmer, Inc.
Devices 00597201303 Femur CR POR FM COMP SIZE CML Rx, Sterile; 00597201304 Femur CR POR FM COMP SIZE CMR Rx, Sterile; 00597201403 Femur CR POR FM COMP SIZE DML Rx, Sterile; 00597201404 Femur CR POR FM COMP SIZE DMR Rx, Sterile; 00597201503 Femur CR POR FM COMP SIZE EML Rx, Sterile; 00597201504 Femur CR POR FM COMP SIZE EMR Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. Zimmer, Inc.
Devices 00597201333 Femur CR POR SURF HDN FEM CO-NID CML, Rx, Sterile; 00597201334 Femur CR POR SURF HDN FEM CO-NID CMR, Rx, Sterile; 00597201433 Femur CR POR SURF HDN FEM CO-NID DML, Rx, Sterile; 00597201434 Femur CR POR SURF HDN FEM CO-NID DMR, Rx, Sterile; 00597201533 Femur CR POR SURF HDN FEM CO-NID EML, Rx, Sterile; 00597201534 Femur CR POR SURF HDN FEM CO-NID EMR, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. Zimmer, Inc.
Devices 65597201333 Femur CR POR FEM SURF HDN HATCP CML, Rx, Sterile; 65597201334 Femur CR POR FEM SURF HDN HATCP CMR, Rx, Sterile; 65597201433 Femur CR POR FEM SURF HDN HATCP DML, Rx, Sterile; 65597201434 Femur CR POR FEM SURF HDN HATCP DMR, Rx, Sterile; 65597201533 Femur CR POR FEM SURF HDN HATCP EML, Rx, Sterile; 65597201534 Femur CR POR FEM SURF HDN HATCP EMR, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. Zimmer, Inc.
Devices 00587806126 Patella MICRO POROUS PAT 26MM X 10MM, Rx, Sterile; 00587806129 Patella MICRO POROUS PAT 29MM X 10MM, Rx, Sterile; 00587806132 Patella MICRO POROUS PAT 32MM X 10MM, Rx, Sterile; 00587806135 Patella MICRO POROUS PAT 35MM X 10MM, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. Zimmer, Inc.
Devices 00597206126 Patella ALL POLY PAT COMP MICRO 26DIA, Rx, Sterile; 00597206129 Patella ALL POLY PAT COMP MICRO 29DIA, Rx, Sterile; 00597206132 Patella ALL POLY PAT COMP MICRO 32DIA, Rx, Sterile; 00597206135 Patella ALL POLY PAT COMP MICRO 35DIA, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. Zimmer, Inc.
Devices 00595202010 Articular Surface XLPE CR ART SURF 1,2/PUR 10, Rx, Sterile; 00595202012 Articular Surface XLPE CR ART SURF 1,2/PUR 12, Rx, Sterile; 00595202014 Articular Surface XLPE CR ART SURF 1,2/PUR 14, Rx, Sterile; 00595202017 Articular Surface XLPE CR ART SURF 1,2/PUR 17, Rx, Sterile; 00595202020 Articular Surface XLPE CR ART SURF 1,2/PUR 20, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. Zimmer, Inc.
Devices 90595202017 Articular Surface XLPE CR ART SURF AE12/PUR 17, Rx, Sterile; 90595202020 Articular Surface XLPE CR ART SURF AE12/PUR 20, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. Zimmer, Inc.
Devices 00597002009 Articular Surface CR ART SURF 12/PURPLE 9, Rx, Sterile; 00597002010 Articular Surface CR ART SURF 12/PURPLE 10, Rx, Sterile; 00597002012 Articular Surface CR ART SURF 12/PURPLE 12, Rx, Sterile; 00597002014 Articular Surface CR ART SURF 12/PURPLE 14, Rx, Sterile; 00597002017 Articular Surface CR ART SURF 12/PURPLE 17, Rx, Sterile; 00597002020 Articular Surface CR ART SURF 12/PURPLE 20, Rx, Sterile; 00597002023 Articular Surface CR ART SURF 12/PURPLE 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. Zimmer, Inc.
Devices 90597002009 Articular Surface CR ART SURF 12/PURPLE 09MM, Rx, Sterile; 90597002010 Articular Surface CR ART SURF 12/PURPLE 10MM, Rx, Sterile; 90597002012 Articular Surface CR ART SURF 12/PURPLE 12MM, Rx, Sterile; 90597002014 Articular Surface CR ART SURF 12/PURPLE 14MM, Rx, Sterile; 90597002017 Articular Surface CR ART SURF 12/PURPLE 17MM, Rx, Sterile; 90597002020 Articular Surface CR ART SURF 12/PURPLE 20MM, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. Zimmer, Inc.
Devices 00597202009 Articular Surface CR ART SURF 12/PURPLE 09, Rx, Sterile; 00597202010 Articular Surface CR ART SURF 12/PURPLE 10, Rx, Sterile; 00597202012 Articular Surface CR ART SURF 12/PURPLE 12, Rx, Sterile; 00597202014 Articular Surface CR ART SURF 12/PURPLE 14, Rx, Sterile; 00597202017 Articular Surface CR ART SURF 12/PURPLE 17, Rx, Sterile; 00597202020 Articular Surface CR ART SURF 12/PURPLE 20, Rx, Sterile; 00597202023 Articular Surface CR ART SURF 12/PURPLE 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. Zimmer, Inc.
Devices 00597602010 Articular Surface AC ART SURF 12/PUR 10, Rx, Sterile; 00597602012 Articular Surface AC ART SURF 12/PUR 12, Rx, Sterile; 00597602014 Articular Surface AC ART SURF 12/PUR 14, Rx, Sterile; 00597602017 Articular Surface AC ART SURF 12/PUR 17, Rx, Sterile; 00597602020 Articular Surface AC ART SURF 12/PUR 20, Rx, Sterile; 00597602023 Articular Surface AC ART SURF 12/PUR 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. Zimmer, Inc.
Devices 00595203110 Articular Surface XLPE CR ART SURF 3,4/SYEL 10, Rx, Sterile; 00595203112 Articular Surface XLPE CR ART SURF 3,4/SYEL 12, Rx, Sterile; 00595203114 Articular Surface XLPE CR ART SURF 3,4/SYEL 14, Rx, Sterile; 00595203117 Articular Surface XLPE CR ART SURF 3,4/SYEL 17, Rx, Sterile; 00595203120 Articular Surface XLPE CR ART SURF 3,4/SYEL 20, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. Zimmer, Inc.
Devices 90595203117 Articular Surface XLPE CR ART SURF AE34/STYEL 17, Rx, Sterile; 90595203120 Articular Surface XLPE CR ART SURF AE34/STYEL 20, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. Zimmer, Inc.
Devices 00597003109 Articular Surface CR ART SURF 34/STRIPE YEL 9, Rx, Sterile; 00597003110 Articular Surface CR ART SURF 34/STRIPE YEL 10, Rx, Sterile; 00597003112 Articular Surface CR ART SURF 34/STRIPE YEL 12, Rx, Sterile; 00597003114 Articular Surface CR ART SURF 34/STRIPE YEL 14, Rx, Sterile; 00597003117 Articular Surface CR ART SURF 34/STRIPE YEL 17, Rx, Sterile; 00597003120 Articular Surface CR ART SURF 34/STRIPE YEL 20, Rx, Sterile; 00597003123 Articular Surface CR ART SURF 34/STRIPE YEL 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. Zimmer, Inc.
Devices 90597003109 Articular Surface CR ART SURF 34/STR YEL 09MM, Rx, Sterile; 90597003110 Articular Surface CR ART SURF 34/STR YEL 10MM, Rx, Sterile; 90597003112 Articular Surface CR ART SURF 34/STR YEL 12MM, Rx, Sterile; 90597003114 Articular Surface CR ART SURF 34/STR YEL 14MM, Rx, Sterile; 90597003117 Articular Surface CR ART SURF 34/STR YEL 17MM, Rx, Sterile; 90597003120 Articular Surface CR ART SURF 34/STR YEL 20MM, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. Zimmer, Inc.
Devices 00597203109 Articular Surface CR ART SURF 34/STRIPE YEL 09, Rx, Sterile; 00597203110 Articular Surface CR ART SURF 34/STRIPE YEL 10, Rx, Sterile; 00597203112 Articular Surface CR ART SURF 34/STRIPE YEL 12, Rx, Sterile; 00597203114 Articular Surface CR ART SURF 34/STRIPE YEL 14, Rx, Sterile; 00597203117 Articular Surface CR ART SURF 34/STRIPE YEL 17, Rx, Sterile; 00597203120 Articular Surface CR ART SURF 34/STRIPE YEL 20, Rx, Sterile; 00597203123 Articular Surface CR ART SURF 34/STRIPE YEL 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. Zimmer, Inc.
Devices 00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10, Rx, Sterile; 00597603112 Articular Surface AC ART SURF 34/STRIPED YEL 12, Rx, Sterile; 00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10, Rx, Sterile; 00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10, Rx, Sterile; 00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10, Rx, Sterile; 00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. Zimmer, Inc.
Devices 00595204110 Articular Surface XLPE CR ART SURF 5-6/STRGRN 10, Rx, Sterile; 00595204112 Articular Surface XLPE CR ART SURF 5-6/STRGRN 12, Rx, Sterile; 00595204114 Articular Surface XLPE CR ART SURF 5-6/STRGRN 14, Rx, Sterile; 00595204117 Articular Surface XLPE CR ART SURF 5-6/STRGRN 17, Rx, Sterile; 00595204120 Articular Surface XLPE CR ART SURF 5-6/STRGRN 20, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. Zimmer, Inc.
Devices 90595204117 Articular Surface XLPE CR ART SURF AE56/STGRN 17, Rx, Sterile; 90595204120 Articular Surface XLPE CR ART SURF AE56/STGRN 20, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. Zimmer, Inc.
Devices 00597004109 Articular Surface CR ART SURF 56/STRIPE GREEN 9, Rx, Sterile; 00597004110 Articular Surface CR ART SURF 56/STRIPE GREEN 10, Rx, Sterile; 00597004112 Articular Surface CR ART SURF 56/STRIPE GREEN 12, Rx, Sterile; 00597004114 Articular Surface CR ART SURF 56/STRIPE GREEN 14, Rx, Sterile; 00597004117 Articular Surface CR ART SURF 56/STRIPE GREEN 17, Rx, Sterile; 00597004120 Articular Surface CR ART SURF 56/STRIPE GREEN 20, Rx, Sterile; 00597004123 Articular Surface CR ART SURF 56/STRIPE GREEN 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. Zimmer, Inc.
Devices 90597004109 Articular Surface CR ART SURF AE56/STR GRN 09MM, Rx, Sterile; 90597004110 Articular Surface CR ART SURF AE56/STR GRN 10MM, Rx, Sterile; 90597004112 Articular Surface CR ART SURF AE56/STR GRN 12MM, Rx, Sterile; 90597004114 Articular Surface CR ART SURF AE56/STR GRN 14MM, Rx, Sterile; 90597004117 Articular Surface CR ART SURF AE56/STR GRN 17MM, Rx, Sterile; 90597004120 Articular Surface CR ART SURF AE56/STR GRN 20MM, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. Zimmer, Inc.
Devices 00597204109 Articular Surface CR ART SURF 56/STRIPE GRN 9, Rx, Sterile; 00597204110 Articular Surface CR ART SURF 56/STRIPE GRN 10, Rx, Sterile; 00597204112 Articular Surface CR ART SURF 56/STRIPE GRN 12, Rx, Sterile; 00597204114 Articular Surface CR ART SURF 56/STRIPE GRN 14, Rx, Sterile; 00597204117 Articular Surface CR ART SURF 56/STRIPE GRN 17, Rx, Sterile; 00597204120 Articular Surface CR ART SURF 56/STRIPE GRN 20, Rx, Sterile; 00597204123 Articular Surface CR ART SURF 56/STRIPE GRN 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. Zimmer, Inc.
Devices 00597604110 Articular Surface AC ART SURF 56/STRIPED GRN 10, Rx, Sterile; 00597604112 Articular Surface AC ART SURF 56/STRIPED GRN 12, Rx, Sterile; 00597604114 Articular Surface AC ART SURF 56/STRIPED GRN 14, Rx, Sterile; 00597604117 Articular Surface AC ART SURF 56/STRIPED GRN 17, Rx, Sterile; 00597604120 Articular Surface AC ART SURF 56/STRIPED GRN 20, Rx, Sterile; 00597604123 Articular Surface AC ART SURF 56/STRIPED GRN 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. Zimmer, Inc.
Devices 00597101101 Provisional CR PROV FRM COMP SIZE AML, Rx, Sterile; 00597101102 Provisional CR PROV FRM COMP SIZE AMR, Rx, Sterile; 00597101201 Provisional CR PROV FRM COMP SIZE BML, Rx, Sterile; 00597101202 Provisional CR PROV FRM COMP SIZE BMR, Rx, Sterile; 00597101303 Provisional CR PROV FRM COMP SIZE CML, Rx, Sterile; 00597101304 Provisional CR PROV FRM COMP SIZE CMR, Rx, Sterile; 00597101403 Provisional CR PROV FRM COMP SIZE DML, Rx, Sterile; 00597101404 Provisional CR PROV FRM COMP SIZE DMR, Rx, Sterile; 00597101503 Provisional CR PROV FRM COMP SIZE EML, Rx, Sterile; 00597101504 Provisional CR PROV FRM COMP SIZE EMR, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. Zimmer, Inc.
Devices 00595501201 Provisional CR-FLEX FEM PROV SZ B-L, Rx, Sterile; 00595501202 Provisional CR-FLEX FEM PROV SZ B-R, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. Zimmer, Inc.
Devices 00598706201 Provisional CRA FEM PROV/CUT GDE SZ BML, Rx, Sterile; 00598706202 Provisional CRA FEM PROV/CUT GDE SZ BMR, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. Zimmer, Inc.
Devices 00597106126 Provisional ALL POLY PAT PROV MICRO SZ 26, Rx, Sterile; 00597106129 Provisional ALL POLY PAT PROV MICRO SZ 29, Rx, Sterile; 00597106132 Provisional ALL POLY PAT PROV MICRO SZ 32, Rx, Sterile; 00597106135 Provisional ALL POLY PAT PROV MICRO SZ 35, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. Zimmer, Inc.
Devices 00597106126 Provisional MIC POROUS PAT PROV 26MMX10MM, Rx, Sterile; 00597106129 Provisional MIC POROUS PAT PROV 29MMX10MM, Rx, Sterile; 00597106132 Provisional MIC POROUS PAT PROV 32MMX10MM, Rx, Sterile; 00597106135 Provisional MIC POROUS PAT PROV 35MMX10MM, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. Zimmer, Inc.
Devices 00597502010 Provisional AC ART SURF PROV 12/PUR 10, Rx, Sterile; 00597502012 Provisional AC ART SURF PROV 12/PUR 12, Rx, Sterile; 00597502014 Provisional AC ART SURF PROV 12/PUR 14, Rx, Sterile; 00597502017 Provisional AC ART SURF PROV 12/PUR 17, Rx, Sterile; 00597502020 Provisional AC ART SURF PROV 12/PUR 20, Rx, Sterile; 00597502023 Provisional AC ART SURF PROV 12/PUR 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. Zimmer, Inc.
Devices 00597503110 Provisional AC ARTSURF PROV 34/STRIPE YEL10, Rx, Sterile; 00597503112 Provisional AC ARTSURF PROV 34/STRIPE YEL12, Rx, Sterile; 00597503114 Provisional AC ARTSURF PROV 34/STRIPE YEL14, Rx, Sterile; 00597503117 Provisional AC ARTSURF PROV 34/STRIPE YEL17, Rx, Sterile; 00597503120 Provisional AC ARTSURF PROV 34/STRIPE YEL 20, Rx, Sterile; 00597503123 Provisional AC ARTSURF PROV 34/STRIPE YEL 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. Zimmer, Inc.
Devices 00597504110 Provisional AC ART SURF PROV 56/STR GRN 10, Rx, Sterile; 00597504112 Provisional AC ART SURF PROV 56/STR GRN 12, Rx, Sterile; 00597504114 Provisional AC ART SURF PROV 56/STR GRN 14, Rx, Sterile; 00597504117 Provisional AC ART SURF PROV 56/STR GRN 17, Rx, Sterile; 00597504120 Provisional AC ART SURF PROV 56/STR GRN 20, Rx, Sterile; 00597504123 Provisional AC ART SURF PROV 56/STR GRN 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. Zimmer, Inc.
Devices 00597102010 Provisional CR ART SURF PROV 12/PURPLE 10, Rx, Sterile; 00597102012 Provisional CR ART SURF PROV 12/PURPLE 12, Rx, Sterile; 00597102014 Provisional CR ART SURF PROV 12/PURPLE 14, Rx, Sterile; 00597102017 Provisional CR ART SURF PROV 12/PURPLE 17, Rx, Sterile; 00597102020 Provisional CR ART SURF PROV 12/PURPLE 20, Rx, Sterile; 00597102023 Provisional CR ART SURF PROV 12/PURPLE 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. Zimmer, Inc.
Devices 00597103110 Provisional CR ART SURF PROV 34/STR YEL 10, Rx, Sterile; 00597103112 Provisional CR ART SURF PROV 34/STR YEL 12, Rx, Sterile; 00597103114 Provisional CR ART SURF PROV 34/STR YEL 14, Rx, Sterile; 00597103117 Provisional CR ART SURF PROV 34/STR YEL 17, Rx, Sterile; 00597103120 Provisional CR ART SURF PROV 34/STR YEL 20, Rx, Sterile; 00597103123 Provisional CR ART SURF PROV 34/STR YEL 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. Zimmer, Inc.
Devices 00597104110 Provisional CR ART SURF PROV 56/STR GRN 10, Rx, Sterile; 00597104112 Provisional CR ART SURF PROV 56/STR GRN 12, Rx, Sterile; 00597104114 Provisional CR ART SURF PROV 56/STR GRN 14, Rx, Sterile; 00597104117 Provisional CR ART SURF PROV 56/STR GRN 17, Rx, Sterile; 00597104120 Provisional CR ART SURF PROV 56/STR GRN 20, Rx, Sterile; 00597104123 Provisional CR ART SURF PROV 56/STR GRN 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. Zimmer, Inc.
Biologics Cardiac Tissue, Non-valved 083696HV02 Class II Cardiac pulmonary patch, recovered from a donor and not tested using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, was distributed. LifeNet Health
Biologics Applied BioSystems (AB) Hi-Di Formamide, 5 ml used with the Hi-DI Formamide 3500 Dx Series. In-Vitro Diagnostic Part Number: 4404307 Lot Number: 1302029 Class III Injection solvent for use with genetic analyzers, stored in warehouse at improper temperatures, was distributed. Life Technologies Holdings Pte Ltd
Devices CHAMPION Medical Recliner, AC Powered with heat and massage, one chair per carton, or one chair wrapped in a blanket if delivered in person. Recliner provides heat and massage after surgery. The following model numbers are affected by this recall: 54PGS636-7JM; 56PLV04-TRL4LJM; 59PT09-F7CJM; 68PT96-TS7JM; 86PT26-TS7JM3; 54PLV04-TRL4LJM; 56PSR20-TS7JM; 59PT19-TFS7PJM3; 85PSR12-TS7JM3; 86PT45-T7KJM; 54PSR20-TS7JM; 56PT21-TS7JM; 65PEV943X-TS7JM3; 85PSR30-TS7JM3; 89PCHA06-TFS7HJM; 54PT26-TS7CJM3; 56PT26-TS7CJM3; 65PFS26-TS7JM; 85PSU103-TS7JM; 89PEV921X-TFS7HPJM3; 54PT45-NJM 56PT45-NJM 65PSH12-S7JM 85PT09-TS7JM3 89PFS04-TFS7HPJM3; 54PT45-TNJM; 56PT45-RNJM; 65PT09-TS7JM; 85PT19-T7JM; 89PFS13-TFS7HPJM3; 54PT45-TS7JM; 58PCHA06-TFS7HJM; 65PT21-TS7JM; 85PT26-TS7JM3; 89PFS15-TFS7HPJM; 54PT56-T7JM; 59PGS493-TFS7HPJM; 66PCHA04-TS7JM; 86PCHA06-TS7JM; 89PFS26-TFS7HPJM3; 54PT96-TS7JM3; 59PGS493-TFS7HPJM3; 66PEV923X-TS7JM3; 86PSU103-TS7JM; 89PFS32-TFS7HPJM3; 56PGS636-7JM; 59PSR12-FS7JM3; 66PFS26-TS7JM; and 86PT09-TS7JM3. Class II There is a possibility of elevated temperatures in the seat pad. In addition, the hospital cord set does not agree with the labeling (information in manual). Invacare Corporation
Drugs CLENZIderm M.D. Acne Therapeutic System Normal to Oily Skin kit, Distributed by OMP, Inc., Long Beach, CA 90806, Kit is comprised of: Daily Care Foaming Cleanser (Salicylic Acid 2%) NDC 62032-111; Pore Therapy (Salicylic Acid 2%) NDC 62032-110 and Therapeutic Lotion (Benzoyl Peroxide 5%) NDC 562032-113). Product under recall is the Pore Therapy (Salicylic Acid 2%), NDC 62032-110. Lot #11L1074, Exp 07/14 Class II cGMP Deviations; during the production process, CLENZIderm M.D. Daily Foam Cleanser was filled into some bottles labeled as CLENZIderm M.D. Pore Therapy Medicis Pharmaceutical Corp
Drugs Eyebright Concentrate Topical Eye Rinse, 1, 2, 4, 8, 16 & 32 fl oz bottles, Produced and distributed by: Wise Woman Herbals, Creswell, OR Lot# 10010 Best used by: 07/14/13 Lot# 10285 Best used by: 02/16/14 Lot# 10640 Best used by: 11/09/14 Lot# 11107 Best used by: 09/16/15 Lot# 11408 Best used by: 05/04/16 Lot# 11711 Best used by: 11/23/16 Lot# 12088 Best used by: 09/04/17 Each lot number has various sizes Product numbers - 1EDCO, 2EDCO, 4EDCO, 8EDCO, 16EDCO, 32EDCO 1 (indicates package size) ED (indicates Eyebright) CO (indicates compound (blended from other finished products) Container sizes - Stock: 1 oz., 2 oz., 4 oz. Non-stock: 8 oz., 16 oz., 32 oz. Class II Lack of Assurance of Sterility; Lack of Assurance of Sterility; product not manufactured under sterile conditions as required for ophthalmic drug products Earthlabs, Inc. DBA Wise Woman Herbals
Food Acidified Tea in a glass bottle with a multi-colored, stick-on label that reads in part: " HARMONY Chai concentrated Fresh brewed on Orcas Island, WA Black Spiced Chai 22oz. (650 ml)***Ingredients: water, Organic Raw Sugar, Black Tea, cloves, cinnamon, Ginger, secret spices, citric Acid***7 05105 01311 4***" There is also a larger size with the same labeling except: "*** 64oz. (1892.70ml)***7 05105 01301 5***" 22 oz. Black Spiced Chai: 7 05105 01311 4 64 oz. Black Spiced Chai: 7 05105 01301 5 The recall involved all lot codes. Class II Product not properly processed Harmony Chai
Food Acidified Tea in a glass bottle with a multi-colored, stick-on label that reads in part: " HARMONY Chai Decaffeinated Fresh brewed on Orcas Island, WA Rooibos Chai 22oz. (624,25ml)***Ingredients: water, Organic Raw Sugar, Rooibos Tea, cloves, cinnamon, Ginger, secret spices, citric Acid***7 94504 02431 9***" There is also a larger size with the same labeling except: "*** 64oz. (1892.70ml)***7 05105 01301 5***" 22 oz. Rooibos Chai: 7 94504 02431 9 64 oz. Rooibos Chai: 7 05105 01301 5 The recall involved all lot codes. Class II Product not properly processed Harmony Chai
Devices Medtronic MiniMed Paradigm Reservoirs, Model No: MMT-326A (1.8mL) and MMT-332A (3.0mL) The model MMT-326A and MMT-332A are syringe type insulin reservoirs intended for use with Medtronic Paradigm series insulin infusion pumps. The two reservoirs are identical except for barrel length and as a result, maximum insulin capacity. The MMT-326A holds a maximum of 1.8ml of insulin whereas the longer MMT-332A reservoir can hold up to 3.0ml of insulin. Both reservoirs are supplied sterile and are labeled for single use. Typically, the reservoir is replaced every tow or three days at the time of infusion set replacement. The Paradigm reservoirs have a shelf life of three years post sterilization. Product Quantity Distributed (Int) 669,672 units MMT-326A Lot Numbers: H8437486 H8441420 H8442973 H8451531 H8486688 H8489386 H8485398 H8500423 H8500472 H8503728 H8512826 H8503372 H8510440 H8539013 H8627745 MMT-332A Lot Numbers: H8416432 H8420977 H8422490 H8424676 H8452933 H8455959 H8457716 H8459557 H8461538 H8463297 H8464121 H8467888 H8469703 H8471745 H8473271 H8476270 H8478398 H8473106 H8492449 H8491921 H8494645 H8496561 H8509305 H8512566 H8515317 H8517079 H8521052 H8541843 H8584244 H8603292 H8604958 H8635301 Class II Medtronic is recalling certain lots of Medtronic MiniMed Paradigm Reservoirs MMT-326A (1.8mL) and MMT-332A (3.0mL) used with Medtronic Paradigm insulin pumps because they may have increased risk for leaking. A leak in the reservoir may result in delivery of less insulin than intended. In addition, if there is a leaky reservoir and an insulin blockage occurs in the infusion set, the pump may not alarm to notify users. Medtronic MiniMed
Food Crave Brothers Les Freres cheese sold with labeling as: Les Freres, Crave Brothers Les Freres, Les Freres Wash Rind Product of USA, Crave Bros Les Freres, Crave Brothers Les Freres Cheese by Pound, Les Freres Crave Brothers, and Les Freres Crave Brothers PO-RK. Cheese was cut and wrapped. All best by dates for the following list of PLUs: Les Freres - PLU #299682, Crave Brothers Les Freres - PLU #299682, Les Freres Wash Rind Product of USA - PLU #294473, Crave Bros Les Freres - PLU #294473, Crave Brothers Les Freres Cheese by Pound - PLU #294473, Les Freres Crave Brothers - PLU #294473, and Les Freres Crave Brothers PO-RK - PLU #294473. Class I Whole Foods Market announces that it is recalling Crave Brothers Les Freres cheese in response to a recall by the Crave Brothers Farmstead Cheese Company of Waterloo, Wisconsin. The cheese is being recalled because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. To date, one illness and one death have been reported. Whole Foods Market
Drugs Duet DHA Balanced, 1) 30 count tablet blister cards and 5 count softgels blister cards combination pack (NDC 44118-775-30 and NDC 44118-800-30) 2) physician samples (carton contain 7 envelopes each with one 5 count tablet blister card and 5 softgels (NDC 44118-800-05) Rx only, Manufactured for Eckson Labs, Wilmington, DE 1) NDC 44118-775-30, Lots 12120001, exp. 10/14 and 12120002, exp. 10/14; NDC 44118-800-30, Lots 12120001, exp 10/14 and 12080002, exp 8/14 2) Physician Samples: NDC 44118-800-05, Lot 12080001 exp. 8/14 and 12120002, exp. 10/14 Class III Subpotent; Beta carotene (Vitamin A) Stayma Consulting Service, LLC.
Drugs Duet DHA 400, containing one 30-count bottle of multi-vitamin tablets (imprinted 800) and one 30-count bottle of Omega-3 softgel capsules, Rx only, Manufactured for Eckson Labs, Wilmington, DE (NDC 44118-807-30) --- Also Manufactured for W.H. Nutritionals, Wilmington, DE (NDC 76331-807-30) NDC 44118-807-30 Lots 40614, exp. 9/14 and 40614A, exp. 9/14 NDC 76331-807-30 lot 39736A, exp. 3/2014, and lot 41667, exp. 12/2014 Class III Subpotent; Beta carotene (Vitamin A) Stayma Consulting Service, LLC.
Drugs Duet DHA 400 ec, containing one 30-count bottle of multi-vitamin tablets (imprinted 800) and one 30-count bottle of Omega-3 softgel capsules, Rx only, Manufactured for Eckson Labs, Wilmington, DE (NDC 44118-809-30) and Manufactured for W.H. Nutritionals, Wilmington, DE (NDC 76331-809-30) NDC 44118-809-30; Lot 40614B, exp. 9/14 and NDC 76331-809-30; lot 39736A, exp. 3/2014, Class III Subpotent; Beta carotene (Vitamin A) Stayma Consulting Service, LLC.
Drugs NataChew, 1) one 90-count bottle of multi-vitamin tablets (imprinted 902), (NDC 44118-902-90) and 2) physician samples containing nine bottles with 5 multi-vitamin tablets (imprinted 902) (NDC 44118-902-05), Manufactured for Eckson Labs, Wilmington, DE 1) Lot 41065, exp 10/14 and 41099, exp 9/14 NDC 44118-902-90 2) Lot 41065A, exp. 9/14 NDC 44118-902-05 Class III Subpotent; Beta carotene (Vitamin A) Stayma Consulting Service, LLC.
Drugs Duet DHA 430, containing one 30-count bottle of multi-vitamin tablets (imprinted 800) and one 30-count bottle of Omega-3 softgel capsules, Manufactured for W.H. Nutritionals, Wilmington, DE --- NDC 76331-808-30 NDC 76331-808-30; lot 39736A, exp. 3/14 and lot 41667, exp. 12/14 Class III Subpotent; Beta carotene (Vitamin A) Stayma Consulting Service, LLC.
Drugs Duet DHA 430 ec, containing one 30-count bottle of multi-vitamin tablets (imprinted 800) and one 30-count bottle of Omega-3 softgel capsules, Manufactured for W.H. Nutritionals, Wilmington, DE (NDC 76331-810-30) NDC 76331-810-30; Lot 39736A, exp. 3/14 Class III Subpotent; Beta carotene (Vitamin A) Stayma Consulting Service, LLC.
Drugs Nata Komplete, containing one 30-count bottle of multi-vitamin tablets (imprinted 909), Manufactured for W.H. Nutritionals, Wilmington, DE (NDC 76331-909-30) and physician samples of nine bottles of 5-multi-vitamin tablets (NDC 76331-909-05 ) NDC 76331-909-30; Lot 40186, exp 5/14 NDC 76331-909-05; Lot 40186, exp. 5/14 (physician samples) Class III Subpotent; Beta carotene (Vitamin A) Stayma Consulting Service, LLC.
Drugs Braintree HalfLytely and Bisacodyl Tablet Bowel Prep Kit (Rx) NDC 52268-523-02 Lot 3013002 Exp. 08/14 Class III Defective Container; Small micro fracture observed in the 2-Liter bottle at the fill line resulting in a small leak when patient reconstitutes the bulk powder Braintree Laboratories Inc.
Devices PleuraGuide Disposable Chest Tube Kit; Product codes: 17100, 17150, and 17200. Indicated to assist with the insertion of thoracic catheters. Part Number: 17100: 10734588, 10734583, 10728237, 10728236, 10728235, 10728234, 10736244, 10736243, 10736242, 10736238, 10734590, 10734589, 10736245, 10852352, 10847222, 10847218, 10842301, 10842299, 10842297, 10840114, 10834292, 10829188, 10852337, 10852334, 10834291, 10834286, 10834284, 10860795, 10857119, 10857111, 10864592, 10864104, 10856867, 10875059, 10875046 , 10871063, 10871059, 10868989, 10879191, 10879190, 10889037, 10887634, 10887292, 10884093, 10879192, 10891329, 10884084;Part Number: 17150: 10728238, 10734584, 10823084, 10800926, 10827874, 10827874, 10834299, 10857110, 10881097, 10874228, 10867130; Part Number 17200: 10728239, 10734585, 10794372, 10802727, 10802725, 10820803, 10825183, 10834338, 10852339, 10864105, 10884087 Class II Individual component's IFUs are not included with the kit. Atrium Medical Corporation
Food Roasted Red Bell Pepper Plus Powder 50 lb carton Product # 68237; Lot # 2193 expiration date January 11, 2013 Lot # 2215 expiration date February 2, 2013 Lot numbers runs for a 24 hour period. The first number is the year; the last three numbers are the Julian date for the day the product was manufactured. Class II The product contained gluten and is sold as gluten free. Pacific Pure Aid
Food Fried Onion Powder 44.092 lb carton Product # DA 10686; Lot # 2171 best-by date June 19, 2013 Lot # 2178 best-by date June 26, 2013 Lot numbers runs for a 24 hour period. The first number is the year; the last three numbers are the Julian date for the day the product was manufactured. Class II The product contained gluten and is sold as gluten free. Pacific Pure Aid
Food Thai Chili Flake Product # 68200; Lot # 2179 best-by date June 27, 2013 Lot numbers runs for a 24 hour period. The first number is the year; the last three numbers are the Julian date for the day the product was manufactured. Class II The product contained gluten and is sold as gluten free. Pacific Pure Aid
Devices GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL, SIZE 3-4, A/P 48 MM, M/L 68 MM, QTY 1, NON-STERILE, REF 71430490, Product Usage: Orthopedic Lot Number 12LM03798 Class II The products were produced using the wrong color material, resulting in the devices being red (used for deep dished inserts) instead of blue (used for cruciate retaining inserts). Smith & Nephew Inc
Food Marmalade Fonariky Net 105.8 oz (3 kg) Product of Russia upc 460161417406 Net Wt. 105.8 oz.product code SS Lot number 24 Class II Marmalade contains undeclared colors and dyes. Zip International Group LLC.
Devices Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure, Latex Free Sterile EO Rx, 1/4" X 4 ", 6 mm X100 mm, (2 Cards/pouch, 1,000 Pouches/box); Distributed in Europe: " Product Number: 39-0058: Medicare Reinforced Wound Closure Strips 1/4" X 4 ", Sterile, Box 1000 pouches 5 strips /pouch, Pouch , 5 strips 6 mm X100 mm Sterile EO Product Number: 40-2893: Wound Closure Strips , Sterile (1,000pouches/box) Rx; Pouch Label: Wound Closure Strips 6 mm X100 mm, 1/4" X 4 ", Rx Product Usage: intended for skin closure and closure support for sutures and staples Product 40-2894: Lot Numbers/Expiration Date Lot Numbers/Expiration 2690-090730 2014-07 2690-111128 2016-11 2690-091207 2014-12 2690-111205 2016-12 2690-100309 2015-03 2690-29661 2017-01 2690-100407 2015-04 2690-29775 2017-01 2690-100429 2015-04 2690-120307 2017-03 2690-100505 2015-05 2690-120410 2017-03 2690-100603 2015-06 2690-120425 2017-04 2690-100607 2015-06 2690-120517 2017-05 2690-100615 2015-06 2690-120803 2017-08 2690-100617 2015-06 2690-120822 2017-08 2690-100709 2015-07 2690-120917 2017-09 2690-100728 2015-07 2690-121019 2017-10 2690-101001 2015-10 2690-121106 2017-10 2690-101101 2015-11 2690-121105 2017-11 2690-101117 2015-11 2690-121128 2017-11 2690-101221 2015-12 2690-130107 2018-01 2690-110121 2016-01 2690-130103 2018-01 2690-110201 2016-02 2690-130109 2018-01 2690-110217 2016-02 2690-130215 2018-02 2690-110223 2016-02 2690-130307 2018-03 2690-110310 2016-03 2690-130213 2018-02 2690-110328 2016-03 2690-130306 2018-03 2690-110415 2016-04 2690-130403 2018-04 2690-110426 2016-04 2690-130409 2018-04 2690-110511 2016-02 2690-130415 2018-04 2690-120804 2017-08 " Product 39-0058 (outside USA): Lot Numbers/ Expiration Date 11305 2016-05 11731 2017-03 11974 2017-08 12353 2018-04 " Product 40-2893 (outside USA): Lot Numbers/ Expiration Date 10425 2014-11 10504 2014-07 10727 2015-02 11178 2015-10 11179 2015-12 11260 2016-01 11261 2016-02 11558 2016-07 Class II Aspen Surgical is recalling Wound Closures because firm could not confirm sterility, after FDA sampling indicated the product may not be sterile. Using the recalled product could lead to infection which may require further treatment including the use of antibiotics. There have been no reports of injuries or illnesses as of 7/18/2013. Aspen Surgical Products, Inc.
Drugs Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771 Lot # 240200, 243000, 244800, 245600, 250800 and 253600. Exp 06/13. Class II Failed Impurites/Degradation Specifications: Test failure of single largest peak at 18 months. VistaPharm, Inc.
Food Plum Organics Mighty 4 Essential nutrition blend; Kale, Strawberry, Amaranth, Greek yogurt in 4 oz pouch. Six pouches per box. USDA Organic. Selling case USPC: 846675003409; Case USPC: 00846675003522 Distributed by Plum Inc., Emery ville, CA. Item 3522 6-Mar-14 7-Mar-14 23-Mar-14 24-Mar-14 25-Mar-14 4-Apr-14 5-Apr-14 6-Apr-14 9-Apr-14 10-Apr-14 11-Apr-14 12-Apr-14 13-Apr-14 18-Apr-14 19-Apr-14 5-May-14 10-May-14 11-May-14 18-May-14 19-May-14 20-May-14 26-May-14 30-May-14 5-Jul-14 6-Jul-14 Class II Intermittent ineffective hermetic seal on pouch package leading to potential spoilage after thermal processing of acidified product . Plum Inc
Food Plum Organics Mighty 4 Essential nutrition blend; Spinach, Kiwi, Barley, Greek yogurt in 4 oz pouch. Six pouches per box. USDA Organic. Selling case USPC: 846675003447; Case UPC: 00846675003560 Distributed by Plum Inc., Emeryville, CA. Item 3560 8-Mar-14 11-Mar-14 19-Mar-14 20-Mar-14 21-Mar-14 22-Mar-14 31-Mar-14 1-Apr-14 7-Apr-14 8-Apr-14 9-Apr-14 23-Apr-14 24-Apr-14 25-Apr-14 27-Apr-14 28-Apr-14 29-Apr-14 4-May-14 14-May-14 15-May-14 16-May-14 17-May-14 25-May-14 26-May-14 28-Jun-14 29-Jun-14 30-Jun-14. Class II Intermittent ineffective hermetic seal on pouch package leading to potential spoilage after thermal processing of acidified product . Plum Inc
Food Plum Organics Mighty 4 Essential nutrition blend; Sweet Potato Blueberry Millet , Greek yogurt in 4 oz pouch. Six pouches per box. USDA Organic. Selling case USPC: 846675003416; Case USPC:00846675003539 Distributed by Plum Inc., Emeryville, CA. Item 3539 6-Mar-14 12-Mar-14 25-Mar-14 26-Mar-14 27-Mar-14 2-Apr-14 3-Apr-14 4-Apr-14 21-Apr-14 22-Apr-14 23-Apr-14 2-May-14 3-May-14 4-May-14 12-May-14 13-May-14 20-May-14 21-May-14 22-May-14 23-May-14 29-May-14 31-May-14 6-Jul-14 7-Jul-14 8-Jul-14 9-Jul-14 10-Jul-14 14-Jul-14 15-Jul-14. Class II Intermittent ineffective hermetic seal on pouch package leading to potential spoilage after thermal processing of acidified product . Plum Inc
Food Plum Organics Mighty 4 Essential nutrition blend; Purple Carrot Berry Quinoa, Greek yogurt in 4 oz pouch. Six pouches per box. USDA Organic. Selling case USPC: 846675003430; Case UPC: 00846675003553. Distributed by Plum Inc., Emeryville, CA. Item 3553 12-Mar-14 13-Mar-14 14-Mar-14 27-Mar-14 28-Mar-14 29-Mar-14 30-Mar-14 19-Apr-14 20-Apr-14 26-Apr-14 29-Apr-14 1-May-14 8-May-14 9-May-14 20-May-14 23-May-14 24-May-14 25-May-14 13-Jul-14 14-Jul-14. Class II Intermittent ineffective hermetic seal on pouch package leading to potential spoilage after thermal processing of acidified product . Plum Inc
Food Plum Organics Mighty 4 Essential nutrition blend; Pumpkin Pomegranate Quinoa, Greek yogurt in 4 oz pouch. Six pouches per box. USDA Organic. Selling case UPC: 846675003454 Case USPC: 00846675003577 Distributed by Plum Inc., Emeryville, CA. Item 3577 11-Mar-14 12-Mar-14 15-Mar-14 16-Mar-14 17-Mar-14 18-Mar-14 25-Apr-14 26-Apr-14 27-Apr-14 5-May-14 6-May-14 7-May-14 8-May-14 26-May-14 27-May-14 28-May-14 31-May-14 3-Jun-14 6-Jun-14 11-Jun-14 12-Jun-14 11-Jul-14 12-Jul-14 23-Mar-14 7-Apr-14 10-Apr-14 11-Apr-14 19-May-14. Class II Intermittent ineffective hermetic seal on pouch package leading to potential spoilage after thermal processing of acidified product . Plum Inc
Devices Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini. Allows for positioning directly on the midline keel of the occiput. K093670 Catalog numbers: Small - 48551044 Medium - 48551045 Large - 48551046 Large Long - 48551047 Mini- 48551048 All lots of the above Class I Stryker has received reports from customers indicating post-operative fracture of the pin that connects the tulip head to the plate body. Stryker Spine
Devices GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO. GYRUS ACMI, REF 3740PK, or REF 94201PK, PKS LYONS, Dissecting Forceps 5mm/45cm, Sterile EO. The Dissectors are sterile, single use electrosurgical devices that are indicated for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general surgical procedures. REF 3740 150080AC 258624MC G166568CC 381809KD 408020AE JF480565 NY492562 REF 3740PK 128971JB 226730IC 226742IC 226743IC 431894CE 431895CE G128677JB REF 94201PK 102290EB 147428AC 167021CC 198596GC 204439HC 204451HC 249022KC 278142BD 320659DD 344712FD 363953ID 373761JD 389095MD 418231BE G386412KD G461037EE JF493195 Class II On April 29, 2013 Olympus Surgical Technologies America R&D received results from an accelerated aging study conducted as part of a new market submission. The study found that one of 60 Dissector units that underwent 3 year accelerated aging failed the dye penetration test indicating that the seal on sterile packaging was compromised. The dissector products are labeled with a 3 year shelf life. Gyrus Medical, Inc
Devices The Discovery NM/CT 570c CT Standalone Scan The Discovery NM/CT 570c hybrid system is a combination of a cardiac dedicated nuclear imaging subsystem and LightSpeed GE CT subsystem. This system is intended for cardiac Nuclear Medicine (NM) diagnostic imaging applications, head and body CT diagnostic imaging applications, as well as attenuation correction and anatomical localization. The Discovery product is a SPECT-CT system. It consists of two back-to-back gantries, the NM Gantry, carrying solid state Cadmium Zinc Telluride (CZT) detectors, the CT Gantry, a single patient table, power distribution unit (PDU), NMV integrated power supply (IPS) , two operator consoles with two acquisition systems (Nuclear and CT), interconnecting cables and associated accessories (ECG gating, etc.). Part numbers H3000SA UFC Cardiac SPECT System, H3001JA UFC Gantry, H3001JE UFC VCT Connecting Kit, H3001JF DISCOVERY NMV/CT 570C Connecting Kit. Class II GE Healthcare has recently become aware of an incident where the wrong part of the patient body was scanned during a CT standalone exam with the Discovery NM/CT 570c GE Healthcare, LLC
Devices Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator. Serial # 108063 Class II Boston Scientific CRM manufacturing quality system recently discovered test artifacts (related to shock charge time) in a small number of implantable defibrillators (ENERGEN DR ICD model E143) which require further investigation. While these devices successfully passed all manufacturing tests and met all requirements, they showed a slightly longer charge time than other devices during a manufacturing test. Boston Scientific CRM Corp
Food Okami Fully Cooked Wild-Caught Lobster Roll with Avocado, in a 7oz plastic tray with lid, to be stored less than or equal to 40 degrees F. 07/15/13 thru 07/19/13 UPC's: 663603141428 Class III The product was misbranded. Raw lobster meat (instead of cooked lobster meat) was used. Green Core
Food Evviva Fresh Peach Spumante, UPC 84279-99137 UPC 84279-99137 Class II Evviva Fresh Peach Spumante and Evviva Strawberry Spumante are being recalled because they contain coloring ingredients not permitted for use in the United States. Johnson Brothers Liquor Company, Inc
Food Evviva Strawberry Spumante, UPC 84279-99138 UPC 84279-99138 Class II Evviva Fresh Peach Spumante and Evviva Strawberry Spumante are being recalled because they contain coloring ingredients not permitted for use in the United States. Johnson Brothers Liquor Company, Inc
Devices Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for detection of human hemoglobin in fecal samples. Part Number 395067. All in-date lots (42 lots total). Lot Number: Manuf. Date: Exp. Date: M207143 27Jul2012 01/31/2014 M208454 21Sep2012 02/28/2014 M210079 19Oct2012 03/31/2014 M211100 30Nov2012 05/31/2014 M212122 20Dec2012 06/30/2014 M212203 17Jan2013 06/30/2014 M301418 22Feb2013 & 28Feb2013 07/31/2014 M202086 24Feb2012 07/31/2013 M203081 16Mar2012 07/31/2013 M203081A 23Mar2012 07/31/2013 M203262 06Apr2012 08/31/2013 M203098 13Apr2012 08/31/2013 M203098A 20Apr2012 08/31/2013 M203098B 25Apr2012 08/31/2013 M203080 27Apr2012 10/31/2013 M203080A 04May2012 10/31/2013 M203080B 11May2012 10/31/2013 M204276 18May2012 09/30/2013 M205199 12May2012 09/30/2013 M205288 22May2012 11/30/2013 M206021 06June2012 11/30/2013 M206166 18June2012 12/31/2013 M207072 05July2012 12/31/2013 M207143 27July2012 01/31/2014 M206259 26June2012 12/31/2013 M207332 30July2012 01/31/2014 M208345 22Aug2012 01/31/2014 M208272 24Aug2012 02/28/2014 M208454 06Sep2012 02/28/2014 M209135 19Sep2012 03/31/2014 M210079 04Oct2012 03/31/2014 M210169 27Oct2012 04/30/2014 M211100 10Nov2012 05/31/2014 M211078 01Dec2012 05/31/2014 M212122 12Dec2012 06/30/2014 M212203 03Jan2013 06/30/2014 M301324 16Jan2013 07/31/2014 M301418 11Feb2013 07/31/2014 M302410 27Feb2013 08/31/2014 M303157 15Mar2013 09/30/2014 M303223 26Mar2013 09/30/2014 M304130 09Apr2013 09/30/2014 Class II Beckman Coulter has received a customer complaint that suggests trending of positive results has increased from approximately 4% to 1 0%. As a result of our investigation, Beckman Coulter has confinned an increase in sensitivity at the borderline positive level. " This testing also demonstrated that the issue does not affect results reported as negative. Beckman Coulter Inc.
Devices Moore Hip Prosthesis Long Fenestrated Stem, several head Diameter, 203 mm Stem length. Used to seat the prosthesis with or without bone cement. 25621400 203600 25711600 203800 25621300 25621500 203700 206500 26601000 60025547 25003900 60016485 60028037 60028040 60028041 60028042 60016492 60028045 60016487 60028036 60028038 60028039 60028043 60034329 60034330 60039203 60038245 60043146 60039161 60039170 60039173 25209700 60039184 60039186 60039201 60039207 60016491 60028044 60039214 60039217 60039218 60039220 60039222 60039223 60039224 60034328 60039158 60039199 60039216 223900 365036 365034 365037 60016497 60039221 60043147 60039166 60039168 60039182 60039183 60039209 60039219 60057784 60039213 60063014 60064868 60063150 60064885 60057785 60064862 60064867 60064886 60064888 60063042 60076067 60076073 60079812 60064887 60083643 60076089 60095965 60095967 60096024 60095966 60095988 60095986 60095978 60095989 60118708 365491 365488 365452 365495 365487 365455 365468 365460 365459 60096023 365469 365610 365470 365609 365476 365473 365483 365611 60187598 365608 60233503 366219 60278488 60293376 60301903 60301909 60301910 366367 366361 60293345 366362 366366 366371 366365 366359 366370 60335336 366368 60335394 366364 60331363 366369 366360 366440 60370153 366363 60323737 60441602 60459779 60501809 60506751 60553757 60532130 60609997 60610068 60506791 60717634 60717637 60717636 60750867 60750869 60823726 60834952 60845453 60933807 60940767 60979560 60990032 60659033 61199167 61496604 61501406 61582442 61582445 61582447 61582449 61582444 61599941 61496594 61658306 60750868 369883 61748928 61783682 61748929 61783684 61815823 61817989 61859934 61927043 61938355 61964729 62051548 62211964 62200345 62200346 62197219 62278696 62258850 62273053 62330362 62330364 62322473 62330365 Class II Zimmer recently conducted a review of historic packaging validations completed. Based on this review, it was determined that a subset of product packaged at a single Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a single packaging tray configuration, which consists of an inner and outer sterile tray, did not pass the established requirements for seal integrity and seal strength. Specifically, there was approximately 2% of either the inner or outer tray that did not pass the established requirements for seal integrity and seal strength. Zimmer, Inc.
Devices Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile EO. Product Usage: The intended use of this device is t protect equipment from contamination during a variety of procedures throughout the clinical setting. Lot: D130432, expires February 2018 Class II Blue Belt Technologies is recalling sterile Monitor Drapes used with their Navio PFS system during orthopedic knee surgery. The drapes are used to cover the Navio PFS system computer monitor and arm assembly and provide a sterile barrier in the surgical suite. The defect is evident when the computer monitor is being draped. The front section of the drape separates from the rest of the drape at the bond joint. Blue Belt Technologies MN
Devices Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ray System Product Usage: MobileDiagnost wDR is a mobile digital radiography X-Ray System. It is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with patient sitting, standing, or lying in the prone or supine positions. Not intended for mammography. System Code - 712001 Class II The Instructions for Use (IFU) for the MobileDiagnost wDR fails to comply with a Federal standard. The IFU does not provide tolerance levels for several generator values as required by 1020.30(h)(3). Philips Healthcare Inc.
Drugs Maalox Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, Assorted Fruit flavor, 65-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, DIN 02243496, UPC 0 58478 44872 5. Lot #: 10097345, Exp 08/13; 10104668, Exp 01/14; 10114317, Exp 03/14; 10120624, Exp 07/14 Class III Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging. Novartis Consumer Health
Drugs Maalox Regular Strength Antacid (calcium carbonate) chewable tablets, 600 mg, Wild Berry flavor, packaged in a) 50-count (UPC 0 58478 44825 1), b) 100-count (UPC 0 58478 44826 8) and c) 145-count (UPC 0 58478 44836 7) tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 02238290. Lot #: a) 10095538, Exp 07/13; 10099449, Exp 09/13; 10104663, Exp 01/14; 10111110, Exp 02/14; 10114312, Exp 04/14; 10120619, Exp 07/14; b) 10095537, Exp 07/13; 10099451, Exp 09/13; 10104664, Exp 01/14; 10111112, Exp 02/14; 10114313, Exp 04/14; 10120620, Exp 07/14; c) 10095528, Exp 07/13; 10106998, Exp 01/14; 10120618, Exp 07/14 Class III Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging. Novartis Consumer Health
Drugs Maalox Advanced Maximum Strength Antacid & Antigas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, Wild Berry flavor, 65-count tablets per bottle, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-62791-65, UPC 3 0067-0376-65 9. Lot #: 10093113, Exp 06/13; 10097332, Exp 08/13; 10101258, Exp 10/13; 10104632, Exp 12/13; 10108852, Exp 01/14; 10104633, 10110688, Exp 02/14; 10111944, Exp 03/14; 10114325, Exp 05/14; 10120609, 10120610, Exp 07/14; 10123084, Exp 09/14 Class III Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging. Novartis Consumer Health
Drugs Maalox Advanced Maximum Strength Antacid & Antigas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, Assorted Fruit flavor, packaged in a) 35-count (NDC 0067-6279-35) (UPC 3 0067-0343-35 4); b) 65-count (NDC 0067-6279-65) (UPC 3 0067-0343-65 1); and c) 90-count (NDC 0067-6279-90) (UPC 3 0067-0343-90 3) tablets per bottle, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622. Lot #: a) 10090971, Exp 08/13; 10101253, Exp 09/13; 10102751, Exp 11/13; 10104624, Exp 01/14; 10108954, 10108955, Exp 02/14; 10111942, 10111943, Exp 03/14, 10117575, Exp 04/14; b) 10095525, Exp 07/13; 10097329, Exp 08/13; 10099437, 10101254, Exp 09/13; 10101255, 10102752, Exp 10/13; 10104625, 10104626, Exp 11/13; 10104627, 10109871, 10110711, 10109182, Exp 01/14; 10109872, 10110003, Exp 02/14; 10111941, Exp 03/14; 10115413, 10116855, Exp 04/14; 10118565, 10118566, Exp 06/14; 10120611, 10120612, Exp 07/14; 10123086, Exp 08/14; c) 10093109, 10093111, 10093112, Exp 06/13; 10095529, 10095540, Exp 07/13; 10097330, 10097331, Exp 08/13; 10099438, 10099439, 10099440, Exp 09/13; 10101256, 10101257, Exp 10/13; 10102753, 10102754, 10104628, Exp 11/13; 10104629, Exp 12/13; 10104630, 10104631, 10108289, 10108290, Exp 01/14; 10107564, 10109868, 10110004, 10110005, Exp 02/14; 10111938, 10111939, 10113621, 10113622, 10114320, 10114321, Exp 03/14; 10114322, 10114323, 10116852, Exp 04/14; 10116853, Exp 05/14; 10118563, 10118564, Exp 06/14; 10120613, 10120614, Exp 07/14; 10123087, 10123088, 10123089, Exp 08/14; 10126000, 10126001, 10126002, Exp 09/14; 10128831, 10128833, Exp 10/14 Class III Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging. Novartis Consumer Health
Drugs Maalox Extra Strength Antacid (calcium carbonate) chewable tablets,1000 mg, Wild Berry flavor, packaged in a) 35-count (UPC 0 58478 44829 9) and b) 65-count (UPC 0 58478 44842 8) tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 02238291. Lot #: a) 10095535, Exp 07/13; 10101288, Exp 10/13; 10104665, Exp 01/14; 10111114, Exp 02/14; 10114314, Exp 04/14; 10120621, Exp 07/14; b) 10095536, Exp 07/13; 10101289, Exp 10/13; 10104666, Exp 01/14; 10111116, Exp 02/14; 10114315, Exp 04/14; 10120622, Exp 07/14 Class III Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging. Novartis Consumer Health
Drugs Maalox, Regular Strength Antacid (calcium carbonate) chewable tablets, 600 mg, Wintergreen flavor, 50-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 02238290, UPC 0 58478 44824 4. Lot #: 10095534, Exp 07/13; 10114311, Exp 04/14 Class III Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging. Novartis Consumer Health
Drugs Maalox Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicone) chewable tablets, 600 mg/60 mg, Wild Berry flavor, 35-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, DIN 02243496, UPC 0 58478 44840 4. Lot #: 10093133, Exp 06/13; 10099452, Exp 09/13; 10104667, Exp 12/13; 10110926, Exp 02/14; 10114316, Exp 04/14; 10120623, Exp 07/14; 10123098, Exp 09/14 Class III Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging. Novartis Consumer Health
Drugs Maalox Nighttime Antacid with Acid Reflux Barrier (calcium carbonate and alginic acid) chewable tablets, 500 mg/200 mg, Mint flavor, 65-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 80000899, UPC 0 58478 10091 3. Lot #: 10107000, Exp 07/13; 10114319, Exp 01/14 Class III Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging. Novartis Consumer Health
Drugs Maalox Nighttime Antacid with Acid Reflux Barrier (calcium carbonate and alginic acid) chewable tablets, 500 mg/200 mg, Cherry flavor, 65-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 80000899, UPC 0 58478 10090 6. Lot #: 10114318, Exp 01/14 Class III Labeling: Incorrect or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging. Novartis Consumer Health
Food Maple flavored lipid-based inclusions. Maple NT-RF and Maple NT-MF, NET WT: 50 lbs, Ingredients: Sugar, vegetable oil (palm, palm kernel), wheat flour, cocoa powder, glucose, extractives of foenugreek, maple sugar, caramel color, soy lecithin. SensoryEffects® , 136 Fox Run Dr., Defiance, OH 43512 Item code 20526 Maple NT-RF lot 2013-36707 and Item code 20525 Maple NT-MF lot 2013-36708 Class II The firm was notified by a customer that a random sample from lot 2013-36707 tested positive for Salmonella. SensoryEffects Powder Systems
Drugs Mavik® trandolapril tablets 4mg, 100 count bottle, Rx only, Manufactured by Halo Pharmaceutical Inc., Whippany, NJ for Abbott Laboratories, North Chicago, IL 60064, USA Lot 22033GY Class III Labeling: Incorrect Package Insert; product packaged with outdated version of the insert AbbVie Inc.
Devices EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001 and R2002. Indicated for the treatment of symptomatic chronic gastroesophageal reflux disease. UN-EXPIRED devices with Expiration dates (8/31/2013, 11/30/2013, 12/31/2013, and 1/31/2014) and following LOT numbers: 401132, 401147, 401152, 401156, 401159, 401167, 401207, 401214, 401219, 401220, 401225, 401227, 401230, 401233, 401236, 401246, 401248, 401251, 401257, 401258, 401259, 401267, 401269, 401271, 401274, and 401276. EXPIRED devices with Expired dates (1/31/2013, 2/28/2013, 3/31/2013 4/30/2013, 5/31/2013, 6/30/2013, and 7/31/2013) and following LOT numbers: 400923, 400927, 400934, 400937, 400940, 400943, 400949, 400961, 400963, 400973, 400976, 400979, 400980, 400981, 400984, 400986, 400992, 400994, 400997, 400998, 401004, 401005, 401009, 401012, 401016, 401017, 401024, 401026, 401029, 401056, 401058, 401059, 401060, 401061, 401062, 401063, 401065, 401072, 401074, 401076, 401079, 401084, 401085, 401092, 401094, 401107, 401114, 401115, 401121, 401129, and 401130. Class II Endogastric Solutions, Inc. has received a limited number of reports relating to the loss of tissue mold control when operating the R2001 or R2002 EsophyX2 device. In one case, surgical intervention was necessary to remove the device. Endogastric Solutions Inc
Devices GE Healthcare, Precision 500D Product Usage: The Precision 500D is designed to perform radiographic and fluoroscopic x-ray examinations. 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There is a potential for the locking nut to loosen out of the Video Monitor Suspension yoke which could result in impact. This will not lead to an immediate fall of the suspended monitor since it will be held in place by the remaining bushing and a screw in the absence of the locking-nut. To date, no complaint or injury has been reported due to this issue. GE Healthcare, LLC
Devices Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50 Pack) and 61301606637 (100 Pack), STEAM --- Manufactured for: Getinge USA, Inc. 1777 E. Henrietta Rd., Rochester, NY 14623. Getinge Assure AccuFast Biological Indicators (BIs) are designed for biological testing of 121°C, 132°C, 134°C and 135°C steam sterilization cycles. The AccuFast BI is a self-contained biological indicator containing Geobacillus stearothermophilus inoculated on a paper carrier and placed in a plastic vial with a small glass ampule containing sterile culture medium. After activation, the plastic vial serves as a culture tube. The chemical indicator on the label changes from blue to black when exposed to steam, distinguishing exposed from unexposed units. This indicator does not indicate adequate sterilization. LOT SR-430 (Expiration 02/06/2014) Class II AccuFast Biological Indicator Lot SR-430 may have been exposed to conditions affecting its viability. This could result in a false negative (or pass) when exposed to sub-lethal sterilization parameters. Getinge USA Inc
Devices Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusion Packs. Model S099B Class II Sorin Group is recalling certain lots of Edwards Lifesciences Suction Wand Model S099B due to presence of plastic particles inside the pouch. Sorin Group USA, Inc.
Devices ConvaTec Flexi-Seal SIGNAL Fecal Management System, Rx Only Product Usage: For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medication. Flexi-Seal Signal FMS Kit - ICC Code: 418000 SAP Code #1262167 Lot# 12-FM-01 and Lot# 12-FM-02. Class III ConvaTec notified their customers on 6/25/2013 regarding the manufacturing irregularity that occurred related to the packaging of certain lots of Flexi-Seal Signal FMS. In certain lots, the lot number convention was duplicated on the packaging. Convatec Inc.
Devices ConvaTec Flexi-Seal SIGNAL +, Rx Only Product Usage: For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medication. Flexi-Seal Signal + ICC Code 418000; SAP Code# 1705108, Lots 12-FM-01 and 12-FM-02. Class III ConvaTec notified their customers on 6/25/2013 regarding the manufacturing irregularity that occurred related to the packaging of certain lots of Flexi-Seal Signal FMS. In certain lots, the lot number convention was duplicated on the packaging. Convatec Inc.
Devices Stryker Visum 300 Ceiling-mounted Exam Light. Product sold under the following part numbers: 0682001410A, 0682001410B, 0682001410C, 0682001410D, 0682001410E, 0682001410F, 0682001410G, and 0682001410H and shipped prior to February 28, 2013. Class II Potential incomplete final weld on the drop tube flange. Stryker Communications
Devices Product Name: nanoPOINT Injector System, item number 37-0000-08. Intended to fold and insert a STAAR Surgical Collamer® nanoFLEX or Afinity IOLs, through surgical procedure in a human eye. Item number 37-0000-08 Lot number of the recalled products: LOT121402 Class II The firm initiated this recall of one lot (121402) of nanoPOINT Injectors after they noticed that Tyvek lids might have been damaged and, therefore, the stability of the sterile barrier might be negatively affected. Medicel Ag
Food Penguinos - four cream filled chocolate cupcakes: gluten, wheat & dairy free & vegan; 4 x 2.2oz cupcakes, net wt 8.8 oz. Ingredients: organic unrefined cane sugar, filtered water, expeller pressed canola oil, rice flour, cocoa powder, tapioca starch, potato starch, Ener-G egg Replacer, gluten free rice milk, organic palm oil shortening, salt, baking soda, natural vanilla, powder, cocoa butter, xanthan gum, natural flavors (gluten free and began) baking powder, pure vanilla extract. Mariposa Baking Co., 5427 Telegraph Ave., D3, Oakland, Ca 94609 Lot 73-39 (on outer case) Julian date 17913 printed on plastic film of individually wrapped cupcake. If frozen, expiry date of 9/28/13. Class II Mariposa Baking received a complaint from consumer who found a piece of coconut in a cupcake. Coconut is not an ingredient of the product and was not listed on the ingredient label Mariposa Baking Co.
Drugs Tagitol V Barium Sulfate Suspension (40% w/v, 30% w/w) Net Contents: 20 mL, (NDC 32909-814-53) Rx Only, Manufactured by E-Z-EM Canada Inc., a subsidiary of E-Z-EM, Inc. Lake Success, NY 11042 Tel: 1-516-333-8230 1-800-544-4624 NDC 32909-814-53 Lot #65846 Class III Failed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibited results above the upper specification for viscosity. Bracco Diagnostics Inc
Food Grove Grow Notes Dried Mushroom, Net Wt. 200g/7 oz. packaged in plastic tray in plastic bag. UPC 6949682800734 Product of China Product label is in Chinese UPC 6949682800734 Class III Grove Grow Notes Dried Mushrooms contain undeclared sulfites at a level of 59 ppm. S & M International Inc
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