Blood product, with positive bacterial detection testing, was distributed.
Platelets Pheresis Leukocytes Reduced Irradiated
Blood Products, which were contaminated with Corynebacterium species, were distributed.
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Blood products, which were collected from a donor with a history of living with someone who is HIV positive, were distributed.
Blood product, collected from a donor who gave history which warranted deferral, was distributed.
Blood products, collected from a donor who did not have a complete physical examination, were distributed.
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood product, which failed to meet the minimum specification for product volume, was distributed.
Blood products, were not quarantined or measured to confirm an acceptable RBC volume, were distributed.
Blood products, quality control and distribution of products that did not meet specifications, were distributed.
Blood products,  which were not frozen within 1 hour of production, were distributed.
Blood product, during irradiation process was out of storage greater than 30 minutes, was distributed.
Community Blood Centers of South Florida, Inc.
Blood  product was not frozen in required time, was distributed.
Blood Bank Of San Bernardino and Riverside Counties
Blood products, for which storage condition was outside the acceptable range, were distributed.
Hoxworth Blood Center University of Cincinnati Medical Center
Blood products, with a low volume, were distributed.
Southern California Permanente Medical Group Blood Donor Center
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Blood Bank of San Bernardino and Riverside Counties
Red Blood Cells Leukocytes Reduced Irradiated
Blood products, not prepared in accordance with specifications, were distributed.
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.
Crystallization: Active pharmaceutical ingredient is precipitating in product solution.
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)
Product may contain undeclared milk product
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)
NuGo Free Carrot Cake, 1.59 oz (45g) Non-Dairy
NuGo Dark Chocolate Chocolate Chip 1.59 oz (45g) Non-Dairy
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)
NuGo Dark Mint Chocolate Chip, 1.59 oz (45g) Non-Dairy
NuGo Dark Peanut Butter Cup, 1.59 oz (45g) Non-Dairy
NuGo Dark Pretzel 1.59 oz (45g) Non-Dairy Non-Dairy
NuGo Slim Crunchy Peanut Butter, 1.59 oz (45g) Non-Dairy
NuGo Slim Espresso, 1.59 oz (45g) Non-Dairy
Blood product, which did not meet the acceptable product specifications for release, was distributed.
Blood and Blood Products for Reprocessing
Blood product, which did not meet the acceptable product specifications, was distributed.
Blood product, which did not meet the acceptable product specifications for release, was distributed
Blood product, which did not meet acceptable product specifications, was distributed.
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed
Blood products, which did not meet acceptable product specifications, were distributed.
Department of Army US Army Blood Bank Center
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
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
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
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
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
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
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
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
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
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
Community Blood Centers of Florida, Inc.
Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Blood product,  collected from a donor in whom donor suitability was not adequately determined, was distributed.
Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Blood products, collected from an ineligible donor, were distributed
Blood products, collected from an ineligible donor, were distributed.
Blood products, collected using an expired blood collection set, were distributed.
Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
Blood product, collected from a donor who was previously deferred, was distributed.
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Platelets Pooled Leukocytes Reduced Irradiated
Northern California Community Blood Bank
Blood products, which did not meet the acceptable product specifications, were distributed.
Worldwide Distribution-USA (nationwide) and the country of Japan.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Applied BioSystems (AB) Hi-Di Formamide, 5 ml used with the Hi-DI Formamide 3500 Dx Series. In-Vitro Diagnostic Part Number: 4404307
Injection solvent for use with genetic analyzers, stored in warehouse at improper temperatures, was distributed.
Nationwide distribution: USA including states of: CA, FL, IN, MN, NJ, NY, OH, RI, SC, SD, TX, and VA.
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.
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).
Nationwide, Great Britain, Mexico, Russia and The Ukraine.
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.
cGMP Deviations; during the production process, CLENZIderm M.D. Daily Foam Cleanser was filled into some bottles labeled as CLENZIderm M.D. Pore Therapy
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.
581x1oz bottles, 263x2 oz bottles, 20x4 oz bottles, 2x8 oz bottles, 1x16 oz bottle, 1x32 oz bottle
Lack of Assurance of Sterility; Lack of Assurance of Sterility; product not manufactured under sterile conditions as required for ophthalmic drug products
Retail stores, one farmers' market in Washington State, and two internet customers in Washington State
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.
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.
Worldwide Distribution - USA (nationwide) and the countries of  Australia, Bermuda, Brazil, Canada, Chile, Columbia, Ecuador, El Salvador, Germany, Japan, Mexico, Netherland, Paraguay, Puerto Rico, Singapore, Uruguay and Venezuela.
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
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.
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.
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.
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
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)
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)
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
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
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)
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 )
Braintree HalfLytely and Bisacodyl Tablet Bowel Prep Kit (Rx)  NDC 52268-523-02
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
PleuraGuide Disposable Chest Tube Kit; Product codes: 17100, 17150, and 17200.   Indicated to assist with the insertion of thoracic catheters.
Individual component's IFUs are not included with the kit.
CA, NJ, KY, OH, and IL Foreign - France, Ireland, Australia, England, and Hungry
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.
The product contained gluten and is sold as gluten free.
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.
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.
International only:  Germany, France, United Arab Emirates, and United Kingdom.
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
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).
Marmalade Fonariky Net 105.8 oz (3 kg) Product of Russia  upc 460161417406
Net Wt. 105.8 oz.product code  SS  Lot number 24
Marmalade contains undeclared colors and dyes.
Worldwide Distribution - US Nationwide in  the state of Florida and in the countries of , Netherlands, and Reditch Worcestershire England
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
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.
Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Only,  Manufactured by VistaPharm, Inc. Largo, FL 33771
Failed Impurites/Degradation Specifications: Test failure of single largest peak at 18 months.
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.
Intermittent ineffective hermetic seal on pouch package leading to potential spoilage after thermal processing of acidified product .
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.
81, 347 cases, total number for all varieties.
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.
81,347 cases. total number for all varieties
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.
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.
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
Stryker has received reports from customers indicating post-operative fracture of the pin that connects the tulip head to the plate body.
Worldwide Distribution - USA (nationwide) including the states of  AL, AZ, CA, FL, GA, IL, IN, KS,KY, MD, MA, MI, MN, MS, MO, NY, NC, OH, PA, SD, TN, TX, VA and WI., and the countries of  BRAZIL, CHINA, AUSTRALIA, CHINA, GERMANY and  INDIA.
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.
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.
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.
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
US distribution in the state of Tennessee.
Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator.
1   (4 devices were implanted and are not part of this action)
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.
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.
The product was misbranded. Raw lobster meat (instead of cooked lobster meat) was used.
AL, AZ, GA, IN,KY, MI, MO , NE, NV, NC, OH, SC.
Evviva Fresh Peach Spumante, UPC 84279-99137
Evviva Fresh Peach Spumante and Evviva Strawberry Spumante are being recalled because they contain coloring ingredients not permitted for use in the United States.
Evviva Strawberry Spumante, UPC 84279-99138
Worldwide Distribution - USA and the country of Canada.
Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for detection of human hemoglobin in fecal samples.
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.
Worldwide Distribution-USA (nationwide) including the states of CT, FL, GA, IL, IN, KS, KY, MA, MI, MN, MT, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VI, and WI, and the countries of Singapore, Canada, Mexico, Arab Emirates, Saudi Arabia, and Hong Kong.
Moore Hip Prosthesis Long Fenestrated Stem, several head Diameter, 203 mm Stem length.   Used to seat the prosthesis with or without bone cement.
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.
Worldwide Distribution and US Nationwide in the states of: CA and PA.   United Kingdom.
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.
60 cartons (20 pieces/carton) 40 in EU, 20 in US.
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.
US Nationwide Distribution including Puerto Rico
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.
240 systems US -- 1 system within Puerto Rico
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Product was shipped to the following states: KY, MN, SD, WA.  Product was also shipped to Canada.
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
The firm was notified by a customer that a random sample from lot 2013-36707 tested positive for Salmonella.
Mavik trandolapril tablets 4mg, 100 count bottle, Rx only,  Manufactured by Halo Pharmaceutical Inc., Whippany, NJ for Abbott Laboratories, North Chicago, IL 60064, USA
Labeling: Incorrect Package Insert; product packaged with outdated version of the insert
EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories.  Models R2001 and R2002.   Indicated for the treatment of symptomatic chronic gastroesophageal reflux disease.
5192 units in the US and 41 units outside the US
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.
Worldwide Distribution - USA Nationwide in the states of AL, AK, AR, CA, CO, CT, FL, GA, HI, ID, IL IN, IA, KS, KY, LA, MD, MA, NMI, MN, MS, MO, NE, NV,NH,NJ, NM, NY, NC,ND, OH, OK OR, PA,SC, SD, TN, TX, UT, VA, WA, WV, WI, WY and the countries of CANADA, FRANCE GERMANY, GREAT BRITAIN ITALY, PANAMA, SAUDI ARABIA.
GE Healthcare, Precision 500D   Product Usage:  The Precision 500D is designed to perform radiographic and fluoroscopic x-ray examinations.
GE Healthcare has recently become aware of a potential safety issue involving the overhead Video Monitor Suspension involving Precision 500D Systems.    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.
Worldwide Distribution -  USA and the country of Canada.
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 121C, 132C, 134C and 135C 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.
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.
Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusion Packs.
Sorin Group is recalling certain lots of Edwards Lifesciences Suction Wand Model S099B due to presence of plastic particles inside the pouch.
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.
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 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.
Worldwide Distributio: US natiowide and to the country of Canada.
Stryker Visum 300 Ceiling-mounted Exam Light.
Potential incomplete final weld on the drop tube flange.
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
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.
one distributor in CA. Number of retail locations forthcoming.
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.
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
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
Failed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibited results above the upper specification for viscosity.
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
Grove Grow Notes Dried Mushrooms contain undeclared sulfites at a level of 59 ppm.