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U.S. Department of Health and Human Services

Enforcement Report - Week of December 2, 2014

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Cryoprecipitated AHF W020011100405, W020011100443, W020011100455, W020011100457, W020011100493, W020011100502, W020011100513 Class II Blood products, for which CMV testing was performed incorrectly, were distributed. Department of the Navy
Biologics Red Blood Cells W020011100405, W020011100407, W020011100416, W020011100432, W020011100437, W020011100442, W020011100455, W020011100457, W020011100460, W020011100485, W020011100486, W020011100488, W020011100489, W020011100491, W020011100493, W020011100502, W020011100503, W020011100510, W020011100513, W020011100518, W020011100520 Class II Blood products, for which CMV testing was performed incorrectly, were distributed. Department of the Navy
Biologics Fresh Frozen Plasma W020011100414, W020011100416, W020011100442, W020011100446, W020011100448, W020011100451, W020011100452, W020011100456, W020011100462, W020011100482, W020011100485 Class II Blood products, for which CMV testing was performed incorrectly, were distributed. Department of the Navy
Food Kerry 52-0197-02, , Net Wt 39.7 lbs (18.00 Kg), B18516.01. lot 0505460103 Class II Kerry Ingredients is recalling two products, Italian Pork and Beef Meatball Seasoning, and Beef and Chicken Meatball Seasoning, because they were processed on the same equipment as Breakfast Sausage Seasoning which tested positive for Salmonella. Kerry determined that the source of the Salmonella was an ingredient used in the Breakfast Sausage Seasoning. Kerry Foods
Food Kerry 52-0189-02 All Purpose Beef & Chicken Meatball Seasoning, Net WT 43.42 lbs (19.69 Kg) , B18517.01. lot 0505460104 Class II Kerry Ingredients is recalling two products, Italian Pork and Beef Meatball Seasoning, and Beef and Chicken Meatball Seasoning, because they were processed on the same equipment as Breakfast Sausage Seasoning which tested positive for Salmonella. Kerry determined that the source of the Salmonella was an ingredient used in the Breakfast Sausage Seasoning. Kerry Foods
Food Item Number 717548.01, Kerry 96002542, Sage Sausage Seasoning, 50 Lb (22.68 KG), Lots: 0329460107, 0428424311 Lots: 0329460107, 0428424311 Class I Kerry determined that eleven products they manufactured contained an ingredient which was found positive for Salmonella. Kerry Foods
Food Item Number 30499117.0, Kerry CI 96004320, Sausage Crumble 30499117, 40.05 lbs (18.16 KG) Lot Number : 0401423904 Lot: 0401423904 Class I Kerry determined that eleven products they manufactured contained an ingredient which was found positive for Salmonella. Kerry Foods
Food Item Number B17017.02, 96051707, Kerry Chicken Noodle Soup Seas 17017, 29.0 LB ( 13.18 KG), Lot Number : 0402409101 Lot: 0402409101 Class I Kerry determined that eleven products they manufactured contained an ingredient which was found positive for Salmonella. Kerry Foods
Food Item Number B18780.01, Kerry Breakfast Sausage Seasoning, Net WT 50 Lb (22.68 KG), Lot Number: 0407424305 Lot: 0407424305 Class I Kerry determined that eleven products they manufactured contained an ingredient which was found positive for Salmonella. Kerry Foods
Food Item Number 723297.01,Kerry 80529TR PC NEW ENGLISH BANG, Net WT 6.7 KG, Lot Number: 0402437604, 0403437502, 0430437506, 0506437603. Lot: 0402437604, 0403437502, 0430437506, 0506437603. Class I Kerry determined that eleven products they manufactured contained an ingredient which was found positive for Salmonella. Kerry Foods
Food Item Number 30511785.01, Kerry Breakfast Sausage Seas, Net Wt 50 Lb (22.68 Kg), Lot Number: 0329460108 Lot: 0329460108 Class I Kerry determined that eleven products they manufactured contained an ingredient which was found positive for Salmonella. Kerry Foods
Food Item Number 30590439.01, Kerry, Brown Butter 30590439.01, Net WT 50 lb (22.68 KG), Lot Number: 0416424102 Lot: 0416424102 Class I Kerry determined that eleven products they manufactured contained an ingredient which was found positive for Salmonella. Kerry Foods
Food Item Number B00584.01, Kerry, Breakfast Sausage Seasoning, Net WT 50 lb (22.68 KG), Lot Number: 0417424306 Lot: 0417424306 Class I Kerry determined that eleven products they manufactured contained an ingredient which was found positive for Salmonella. Kerry Foods
Food Item Number B17416.01, Kerry, Rosemary & Olive Oil Seas Baptistas Item # 00391, Net WT 50.0 lb (22.68 KG), Lot Number: 0416424101, 0501424101 Lot: 0416424101, 0501424101 Class I Kerry determined that eleven products they manufactured contained an ingredient which was found positive for Salmonella. Kerry Foods
Food Item Number 721698.01, Kerry, Breakfast Sausage Seasoning, Net WT 50 Lb (22.68 KG), Lot Number: 0417424307 Lot: 0417424307 Class I Kerry determined that eleven products they manufactured contained an ingredient which was found positive for Salmonella. Kerry Foods
Food Item Number 30600397.01, 96005094, Kerry, Chicken Noodle Soup Seasoning, Net WT 40 Lb (18.18 KG), Lot Number: 0418409102 Lot: 0418409102 Class I Kerry determined that eleven products they manufactured contained an ingredient which was found positive for Salmonella. Kerry Foods
Devices Instructions for Use for the blue endo moresolution Morcellator System, Model 55-000011, consisting of the control unit, hand-grip, flexible shaft, trocars/obturators, sleeves, valves, and blades. Instructions for Use V. 02.08.2012 that was provided with control units bearing the following serial numbers: 4861300-002, 6283800-002, 6283800-004, 6283800-010, 6283800-023, 6823800-045, 6283800-008, 6283800-011, 6283800-013, 7010201-017, 6283800-014, 6283800-016, 6283800-017, 6283800-019, 6283800-020, 6283800-021, 6283800-022, 6283800-029, 6283800-024, 6283800-026, 6283800-027, 6283800-030, 6283800-031, 6283800-034, 6283800-037, 6283800-038, 6283800-039, 6283800-040, 6283800-042, 6283800-043, 6283800-044, 6283800-046, 6283800-047, 6283800-048,  ...
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Class II Some of the information in the Instructions for Use was omitted. Market-Tiers Inc
Food MaraNatha Roasted Crunchy Almond Butter, 16 oz., UPC 51651092012; Whole Foods 365 Crunchy Almond Butter, 16 oz.., UPC 99482406561. Best By Dates Range: 26DEC14 thru 06JUN15 and 24DEC14 thru 26DEC14 Class I Products have the potential to be contaminated with Salmonella. nSpired Natural Foods, Division of the Hain Celestial Group
Food MaraNatha Organic Roasted Crunchy Almond Butter, 16 oz., UPC 51651092036. Best By Dates Range: 4JUNE15 Class I Products have the potential to be contaminated with Salmonella. nSpired Natural Foods, Division of the Hain Celestial Group
Food MaraNatha Organic Raw Crunchy Almond Butter, 16 oz., UPC 51651092128. Best By Dates Range: 22DEC14 thru 01JUL15 Class I Products have the potential to be contaminated with Salmonella. nSpired Natural Foods, Division of the Hain Celestial Group
Food Trader Joe's Raw Crunchy Almond Butter Unsalted, 16 oz., UPC 919890. Best By Dates Range: 28DEC14 thru 18JUN15 Class I Products have the potential to be contaminated with Salmonella. nSpired Natural Foods, Division of the Hain Celestial Group
Food MaraNatha No Stir Crunchy Almond Butter, 12 oz., UPC 51651093699. Best By Dates Range: 17DEC14 thru 20JUL15 and 17DEC14 thru 18JUL15 Class I Products have the potential to be contaminated with Salmonella. nSpired Natural Foods, Division of the Hain Celestial Group
Food MaraNatha No Stir Crunchy Almond Butter low in sodium, 340 grams, UPC 51651093460. Best By Dates Range: 16DEC14 thru 14MAY15 Class I Products have the potential to be contaminated with Salmonella. nSpired Natural Foods, Division of the Hain Celestial Group
Food MaraNatha Raw Creamy Almond Butter, 16 oz., UPC 51651092180 Trader Joe's Raw Creamy Almond Butter Unsalted, 16 oz., UPC 00569958. Best By Dates Range: 05APR15 thru 02JUL15; 27DEC14 thru 18JUL15; Class I Products have the potential to be contaminated with Salmonella. nSpired Natural Foods, Division of the Hain Celestial Group
Food MaraNatha Raw Almond Butter, 340 grams, UPC 51651093064. Best By Dates Range: 07MAY15 thru 05JUN15; Class I Products have the potential to be contaminated with Salmonella. nSpired Natural Foods, Division of the Hain Celestial Group
Food MaraNatha Organic Raw Creamy Almond Butter, 8 oz., UPC 51651092630; MaraNatha Organic Raw Creamy Almond Butter, 16 oz., UPC 51651092173. Best By Dates Range: 13APR15 thru 30JUN15; 14APR15 thru 01JUL15; Class I Products have the potential to be contaminated with Salmonella. nSpired Natural Foods, Division of the Hain Celestial Group
Food MaraNatha Roasted Almond Butter, 340 grams, UPC 51651093057. Best By Dates Range: 11DEC14 thru 02JUN15 Class I Products have the potential to be contaminated with Salmonella. nSpired Natural Foods, Division of the Hain Celestial Group
Food MaraNatha Roasted Creamy Almond Butter, 16 oz., UPC 51651060325; MaraNatha Roasted Creamy Almond Butter, 26 oz., UPC 51651092897; Whole Foods 365 Creamy Almond Butter, 16 oz., UPC 99482406578. Best By Dates Range: 24DEC14 thru 17JUN15; 04DEC14 thru 21APR15; 23DEC14 thru 24DEC14; Class I Products have the potential to be contaminated with Salmonella. nSpired Natural Foods, Division of the Hain Celestial Group
Food MaraNatha Organic Roasted Creamy Almond Butter, 16 oz., UPC 51651060219; Whole Foods 365 Organic Creamy Almond Butter, 16 oz., UPC 99482405960. Best By Dates Range: 23DEC14 thru 04JUN15; 23DEC14 Class I Products have the potential to be contaminated with Salmonella. nSpired Natural Foods, Division of the Hain Celestial Group
Food MaraNatha No Stir Creamy Almond Butter, 12 oz., UPC 51651093682; MaraNatha No Stir Creamy Almond Butter, 340 grams, UPC 51651093453; Kroger No Stir Creamy Almond Butter, 12 oz., UPC 11110791214; Best By Dates Range: 16DEC14 thru 11MAY15 11DEC14 thru 05JUL15; 14DEC14 thru 14JUL15; 12DEC14 thru 21JUL15; Class I Products have the potential to be contaminated with Salmonella. nSpired Natural Foods, Division of the Hain Celestial Group
Food MaraNatha No Stir Raw Maple Creamy Almond Butter, 12 oz., UPC 51651093866. Best By Dates Range: 30MAY15 thru 31MAY15 Class I Products have the potential to be contaminated with Salmonella. nSpired Natural Foods, Division of the Hain Celestial Group
Food Safeway Open Nature Creamy Almond Butter Salted, 12 oz., UPC 79893113746 Best By Dates Range: 11DEC14 thru 03JUL15 Class I Products have the potential to be contaminated with Salmonella. nSpired Natural Foods, Division of the Hain Celestial Group
Food MaraNatha Roasted Creamy Almond Butter No Sodium, 737 grams, UPC 51651092869 Best By Dates Range: 08DEC14 thru 03JUL15 Class I Products have the potential to be contaminated with Salmonella. nSpired Natural Foods, Division of the Hain Celestial Group
Food Arrowhead Mills Organic Crunchy Peanut Butter No Salt Added, 16 oz., UPC 74333470328. Best By Dates Range: 31DEC14 thru 14MAY15 Class I Products have the potential to be contaminated with Salmonella. nSpired Natural Foods, Division of the Hain Celestial Group
Food MaraNatha Organic Roasted Crunchy Peanut Butter, 16 oz., UPC 51651092203. Best By Dates Range: 06APR15 thru 07APR15 Class I Products have the potential to be contaminated with Salmonella. nSpired Natural Foods, Division of the Hain Celestial Group
Food MaraNatha Organic Roasted Crunchy Peanut Butter Hint of Sea Salt, 16 oz., UPC 51651092333; MaraNatha Organic Crunchy Peanut Butter Hint of Sea Salt, 26 oz., UPC 51651092920; MaraNatha Organic Crunchy Peanut Butter, 500 gram, UPC 51651093316 Best By Dates Range: 31DEC14 thru 15MAY15; 02JAN15 thru 15MAY15; 02JAN15 thru 25JUN15; Class I Products have the potential to be contaminated with Salmonella. nSpired Natural Foods, Division of the Hain Celestial Group
Food MaraNatha Organic No Stir Roasted Crunchy Peanut Butter, 16 oz, UPC 51651092364. Best By Dates Range: 05JAN15 thru 28JUN15; Class I Products have the potential to be contaminated with Salmonella. nSpired Natural Foods, Division of the Hain Celestial Group
Food MaraNatha No Stir Crunchy Peanut Butter, 500 grams, UPC 51651093415. Best By Dates Range: 13MAR15 thru 28JUN15 Class I Products have the potential to be contaminated with Salmonella. nSpired Natural Foods, Division of the Hain Celestial Group
Food MaraNatha Organic Roasted Creamy Peanut Butter, 16 oz., UPC 51651092197; Arrowhead Mills Organic Creamy Peanut Butter, 16 oz., UPC 74333470526. Best By Dates Range: 7-Apr-15; 31DEC14 thru 14MAY15. Class I Products have the potential to be contaminated with Salmonella. nSpired Natural Foods, Division of the Hain Celestial Group
Food MaraNatha Organic Creamy Peanut Butter with Hint of Sea Salt, 16 oz., UPC 51651092326; MaraNatha Organic Creamy Peanut Butter with Hint of Sea Salt, 26 oz., UPC 51651092913; MaraNatha Organic Creamy Peanut Butter, 500 grams, UPC 51651093309. Best By Dates Range: 03JAN15 thru 25JUN15; 03JAN15 thru 24JUN15; Class I Products have the potential to be contaminated with Salmonella. nSpired Natural Foods, Division of the Hain Celestial Group
Food MaraNatha Organic No Stir Creamy Peanut Butter, 16 oz, UPC 51651092357. Best By Dates Range: 04JAN15 thru 27JUN15; Class I Products have the potential to be contaminated with Salmonella. nSpired Natural Foods, Division of the Hain Celestial Group
Food MaraNatha No Stir Creamy Peanut Butter, 16 oz., UPC 51651092210; MaraNatha No Stir Creamy Peanut Butter, 500 gram, UPC 51651093408. Best By Dates Range: 06JAN15 thru 20MAY15; 20-May-15; Class I Products have the potential to be contaminated with Salmonella. nSpired Natural Foods, Division of the Hain Celestial Group
Devices ARCHITECT Total T3 Reagent Kit (7K64) consists of: - 1 or 4 Bottle(s) (6.6 mL/27.0 mL) anti-T3 (sheep) coated microparticles in MES buffer with sheep IgG stabilizers. Minimum Concentration: 0.08% solids. Preservative: ProClin 300. - 1 or 4 Bottle(s) (5.9 mL/26.3 mL) T3 acridinium-labeled conjugate in citrate buffer with NaCl and Triton X-100 stabilizers. Minimum concentration: 0.33 ng/mL. Preservative: ProClin 300. The ARCHITECT Total T3 (TT3) assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of total triiodothyronine (Total T33) in human serum and plasma. Product List Numbers, Lot Numbers, and Expiration Dates: 1) List Number: 7K64-20, Lot Number 38901UI00, Expires: 29-Jan-15; 2) List Number: 7K64-25; Lot Number 38901UI01, Expires: 29-Jan-15 Class II 17% of ARCHITECT Total T3 Reagent Kit, LN 7K64-20/-25 reagent lots 38901UI00 and 38901UI01 may exhibit lower Relative Light Units (RLUs) than expected, which in turn may result in controls out of range or patient results higher than expected. Abbott Ireland Diagnostics Division
Food Whole Foods Market Plain Streusel Coffeecake (no nuts), 20 oz.. packaged in a clear plastic dome/black plastic base Sell By September 19-30, 2014 Class I Product contains undeclared pecans Whole Food Market
Devices Trabecular Metal Tibial Impactor. Product Usage: TM Tibial Impactor pads are used in conjunction with the TM Tibial Impactor to impact the tibial tray onto the tibia. Item 00-5953-056-00; all lots Class II To provide clarifying instructions relating to the assembly/disassembly of the Trabecular Metal Tibial Impactor with/from TM tibial Impactor Pads due to complaints regarding Tibal Impactor pad fracture. Zimmer, Inc.
Devices Trabecular Metal Tibial Impactor Replacement Pads. Product Usage: TM Tibial Impactor pads are used in conjunction with the TM Tibial Impactor to impact the tibial tray onto the tibia. Item 00-5953-056-06; all lots Class II To provide clarifying instructions relating to the assembly/disassembly of the Trabecular Metal Tibial Impactor with/from TM tibial Impactor Pads due to complaints regarding Tibal Impactor pad fracture. Zimmer, Inc.
Devices Dharma Cavity Varnish with Fluoride All Lots - Item #14-00015 Class II During an FDA inspection, it was found that the products are being marketed without a cleared 510k. Dharma Research, Inc.
Devices Dharma Cavity Varnish 15mL All Lots - Item # 14-00016 Class II During an FDA inspection it was found that the products are marketed without a cleared 510k. Dharma Research, Inc.
Biologics Bone 123437108; 123437112; 123437120; 123437121; 123437122; 123437123; 123437124; 123437125; 123437127; 123437128; Class I Human tissue allografts, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease, were distributed. AlloSource, Inc.
Biologics Source Plasma 11400430805; 11400324797; 11400292270; 11400341255; 11400312500; 11400347024; Class III Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. CSL Plasma, Inc.
Cosmetics All lots of non-medicated, scented, unscented, and sensitive varieties of baby wipes, packaged in 14 count to 1000 count sizes of plastic flow wrap soft packs, refill, trial, and plastic tubs, labeled as: Kidgets Baby Wipes, Distributed by Family Dollar, Charlotte, NC 28201; Walgreen's Well Beginnings Baby Wipes, Distributed by Walgreens, Deerfield, IL.; Member's Mark Baby Wipes, Distributed by Walmart de Mexico, Ciudad De Mexico, Mexico; Simply Right Baby Care Wipes, Distributed by Sam's Club, Bentonville, AR; Cuties Premium Baby Wipes Distributed by First Quality, Great Neck, NY, Manufactured by First Quality Products, Inc., McElhattan, PA; Tender Touch Baby Wipes, Manufactured by First Quality Products, Inc., McElhattan, PA ; Well Beginnings Wipes, Distributed by Walgreens, Deerfield, IL; Femtex Premium Feminine Wipes, Distributed by Family Dollar, Charlotte, NC 28201; Fred's Kids Baby Wipes, Distributed by Fred's Inc. Memphis, TN; and Sunny Smiles Baby Wipes, Distributed by Walgreens, Deerfield, IL. Also sold as trial packs inside DIAPERS.COM DIAPER SZ 5 CLUB 1/156; IAPERS.COM DIAPER SZ 3 CLUB 1/200;DIAPERS.COM DIAPER SZ 4 CLUB 1/176; WELL BEGINNINGS DIAPER SZ 3 JR CLUB 1/96;WELL BEGINNINGS DIAPER SZ 4 JR CLUB 1/82;WELL BEGINNINGS DIAPER SZ 5 JR CLUB 1/70; SIMPLY RIGHT DIAPER SZ 5 CLUB 1/196; SMPLY RIGHT DIAPER SZ 3 CLUB 1/252; SMPLY RIGHT DIAPER SZ 4 CLUB 1/225; KIDGET DIAPER SZ5 JR CLUB 1/62; KIDGET DIAPER SZ 3 JR CLUB 1/86; KIDGET DIAPER SZ4 JR CLUB 1/74; KIDGET DIAPER SZ 6 JR CLUB 1/54; FRED DIAPER SZ 3 JR CLUB 1/86; and DIAPER SZ 5 JR CLUB 1/62. All lots, beginning with 00114 increasing by one number sequentially until 29414, with UPC codes: 0032251025778, 0032251026508, 0032251026515, 0032251026522, 0032251026539, 0032251026546, 0032251026553, 0032251063381, 0032251089411, 0032251089428, 0032251089466, 0032251094491, 0078742023038, 0078742057415, 0084579123643, 0084579126637, 0084579126644, 0084579126651, 0084579126668, 0084579126750, 0090891125234, 0090891125289, 0090891125296, 0090891125302, 0090891125319, 0090891128129, 0090891128136, 0311917147246, 0311917152080, 0311917152097, 0311917152103, 0311917152110, 0311917152127, 0311917152134, 0681131077699. Class II All lots of Disposable baby wipes manufactured by Nutek Disposables, Inc., were recalled due to complaints of discoloration and/or odor and irritation, later determined to be the result of bacterial contamination confirmed as B. cepacia. Nutek Disposables, Inc.
Devices Siemens Dimension® HB1C Flex® reagent cartridge; Dimension® Hemoglobin A1c (HB1C) Flex® reagent cartridge on the Dimension® clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of hemoglobin A1c (HbA1c) in human anticoagulated whole blood. Measurements of hemoglobin A1c are effective in monitoring long-term glucose control in individuals with diabetes mellitus. Siemens Dimension Vista® HbA1c Flex® reagent cartridge: Catalog Number K3105A, Siemens Material Number (SMN) 10470481, Lot Numbers 13294BA 13308BA 13329AA 13350AA 14006AA 14041BA 14069BB 14083BA Siemens Dimension® HB1C Flex® reagent cartridge: Catalog Number DF105A, Siemens Material Number (SMN) 10483822, Lot Numbers GA4266 BA4273 BA4280 BA4287 GA4301 GA4315 GC4322 GA4343 GA4350 GA4357 GA5013 GA5020 Class II Siemens Healthcare Diagnostics is conducting a field recall for certain lots of the Dimension Vista® HbA1c Flex® reagent cartridge and lots of Dimension® HB1C Flex® reagent cartridge due to confirmed positive bias averaging 0.4% Hemoglobin A1c units and occasionally up to 1.0% HbA1c units for patient samples when compared to the National Glycohemoglobin Standardization Program (NGSP). QC samples may exhibit a similar bias. Siemens Healthcare Diagnostics, Inc.
Biologics Red Blood Cells Leukocytes Reduced W045214012038 Class II Blood products, collected from an ineligible donor, were distributed. South Bend Medical Foundation, Inc.
Biologics Plasma Frozen within 24 hours (FP24) W045214012038 Class II Blood products, collected from an ineligible donor, were distributed. South Bend Medical Foundation, Inc.
Biologics Source Plasma FD0851469; Class II Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. DCI Biologicals LLC
Biologics Source Plasma 08101301408; 08101339297; 08101330428; 08101260546; 08101231489; 08101153206; 08101177662; 08101141694; Class II Blood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. CSL Plasma, Inc.
Drugs Normosol-R pH 7.4 Multiple Electrolytes Injection Type 1, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7670-09. Lot # 32-082-JT; Exp. 08/15 Class II Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks. Hospira Inc.
Drugs Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7902-09. Lot # 34-017-JT; Exp. 10/15 Lot # 35-100-JT; Exp. 11/15 Class II Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks. Hospira Inc.
Drugs 5% Dextrose Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7922-09. Lot # 33-094-JT; Exp. 09/15 Lot # 35-028-JT; Exp. 11/15 Class II Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks. Hospira Inc.
Drugs 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7926-09. Lot # 33-095-JT; Exp. 09/15 Lot # 36-030-JT; Exp. 12/15 Class II Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks. Hospira Inc.
Drugs Lactated Ringer's and 5% Dextrose Injection, USP; 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7929-09. Lot # 34-134-JT Exp. 10/15 Lot # 34-166-JT Exp. 10/15 Class II Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks. Hospira Inc.
Drugs 5% Dextrose and 0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7941-09. Lot # 32-104-JT; Exp. 08/15 Lot # 34-136-JT; Exp. 10/15 Lot # 36-092-JT; Exp. 12/15 Class II Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks. Hospira Inc.
Drugs Lactated Ringer's Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7953-09. Lot # 32-099-JT; Exp. 08/15 Lot # 32-103-JT; Exp. 08/15 Lot # 34-070-JT; Exp. 10/15 Lot # 34-086-JT; Exp. 10/15 Lot # 34-165-JT; Exp. 10/15 Lot # 35-085-JT; Exp. 11/15 Lot # 35-115-JT; Exp. 11/15 Lot # 35-121-JT; Exp. 11/15 Lot # 36-057-JT; Exp. 12/15 Class II Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks. Hospira Inc.
Drugs Normosol-R Multiple Electrolytes Injection Type 1, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7967-09. Lot # 32-081-JT; Exp. 08/15 Lot # 34-115-JT; Exp. 10/15 Class II Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks. Hospira Inc.
Drugs 0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09. Lot # 32-044-JT; Exp. 08/15 Lot # 32-072-JT; Exp. 08/15 Lot # 32-102-JT; Exp. 08/15 Lot # 33-028-JT; Exp. 09/15 Lot # 33-046-JT; Exp. 09/15 Lot # 33-049-JT; Exp. 09/15 Lot # 33-061-JT; Exp. 09/15 Lot # 33-085-JT; Exp. 09/15 Lot # 33-096-JT; Exp. 09/15 Lot # 33-101-JT; Exp. 09/15 Lot # 33-102-JT; Exp. 09/15 Lot # 34-016-JT; Exp. 10/15 Lot #  ...
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Class II Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks. Hospira Inc.
Drugs 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7985-09. Lot # 33-027-JT; Exp.09/15 Lot # 33-045-JT; Exp.09/15 Lot # 33-097-JT; Exp.09/15 Lot # 35-068-JT; Exp.11/15 Lot # 36-112-JT; Exp.12/15 Lot # 37-012-JT; Exp.01/15 Class II Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks. Hospira Inc.
Drugs Sterile Water for Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7990-09. Lot# 36-084-JT; Exp.12/15 Class II Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks. Hospira Inc.
Drugs Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only. Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC: 0591-0398-60, UPC 3 05910 39860 6. Lot # 694320A, Expiry: 02/28/2015. Class II Failed Tablet/Capsule Specifications: Presence of split or broken tablets. Actavis Laboratories, FL, Inc.
Devices GemStar infusion pump, list numbers 13000 and 13100, GemStar Infusion Pump (pain management) list number 13150. Product Usage The pump is suitable for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products. The epidural route is recommended to provide anesthesia or administer analgesia for periods up to 96 hours. List Numbers: 13000, 13100, 13150; Serial Numbers: All Serial Numbers Class II The GemStar User/Service Manual should be removed from these websites as soon as possible to ensure that individuals will not have access to the codes that would allow them to manipulate the infusion rates set by their physicians. The dosage reset codes required to change the settings on GemStar infusion pumps have been accessed via website sponsors (by downloading the GemStar User/Service Manual featured on the sponsors' websites) and subsequently used in changing the infusion rate set by their doctors. Hospira Inc.
Devices GemStar infusion pump, list numbers 13086 and 13087, GemStar infusion pump (pain management) list number 13088. Product Usage The pump is suitable for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products. The epidural route is recommended to provide anesthesia or administer analgesia for periods up to 96 hours. List Numbers: 13086, 13087, 13088; Serial Numbers: All Serial Numbers Class II The GemStar User/Service Manual should be removed from these websites as soon as possible to ensure that individuals will not have access to the codes that would allow them to manipulate the infusion rates set by their physicians. The dosage reset codes required to change the settings on GemStar infusion pumps have been accessed via website sponsors (by downloading the GemStar User/Service Manual featured on the sponsors' websites) and subsequently used in changing the infusion rate set by their doctors. Hospira Inc.
Devices AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated. Affected software version: Software versions 5.0.1738 and 5.0.1742 only. Affected serial numbers: 248-052, 248-066, 248-088, 249-0059, 249-0133, 249-0134, 249-0139. Class II Potential failure of AlignRT to assert interlock. Vision Rt Inc
Drugs Potassium Chloride Injection, 10mEq per 100mL, 100 mL Sterile single dose container bags, Rx only, Baxter USA, NDC 0338-0709-48, Product Code 2B0826. Lot #: P319160, Exp 06/30/15 Class II Labeling: Label Error On Declared Strength: Bags of Potassium Chloride 10 mEq per 100 mL were incorrectly overpouched with wraps labeled as Potassium Chloride Injection, 20 mEq per 100 mL. Baxter Healthcare Corp.
Devices Abbott m2000sp is intended use as an automated system for performing sample preparation for nucleic acid testing. List Number: 09K14; Models: E series, G series Class II Abbott Molecular identified some versions of Application Specifications (App Spec) are incompatible with m2000sp system software version 6.0 and 7.0. This may cause Error Code 9000 ("An unexpected error has occurred: Software error") to generated when <Available Reagent Packs> screen is selected. Abbott Molecular
Devices Oxoid Legionella Pneumo Groups 2-14 Latex Test, DR0802M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent, DR0802. The product is a latex agglutination test for the identification of predominant Legionella species grown on plate media from patients with suspected Legionellosis or from environmental sources. The test allows a separate identification of Legionella pneumophila serogroup 15 and serogroups 1-14 and detection of other pathogenic non L. pneumophila, Legionella strains. DR0802M box lot 1301909, Exp. 30Sep2014 Class II A reagent within the test may return false negative results. Remel Inc
Devices Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Latex Reagent, DR0802. The responsible firm on the label is Oxoid Ltd. DR0800M box lot 1316151, Exp. 30Sep2014 Class II A reagent within the test may return false negative results. Remel Inc
Devices Gel-E Donut : 92025-A (Extra Small), 92025-B (Small), 92025-C (Medium) and Squishon 2 91033-2. The products are intended to support and cradle a baby's head and/or body. All lot codes Class I Mold on gel filled Gel-E and Squishon products Philips Medical Systems, Inc.
Devices Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only. The disposable Falope-Ring Band Applicator is a sterile, two-band, dual-incision instrument. The two-band applicator enables the physician to occlude both Fallopian tubes without removing the applicator from the abdominal cavity. The Falope-Ring Band and Applicator Kits are indicated for use for female sterilization (permanent contraception). All lots Class II All packages of Falope Ring Band Applicator kits are being recalled due to compromises in sterile packaging that could be associated with bacterial contamination that might lead to patient infection. Gyrus Acmi, Incorporated
Veterinary Simply Nourish Dog Treats Biscotti with Beef & Sweet Potato Net Wt. 4 oz. Distributed by: Simply Nourish Pet Food Company 19601 N. 27th Avenue, Phoenix, AZ USA 85027 Made in USA UPC 73725747061 Lot 021114 and Lot 021414 Exp 2/16 Class III Simply Nourish Beef Biscotti with Sweet Potatoes contain improper bag seals which allow moisture into the packaging. Loving Pets
Food Los Chileros de nuevo mexico gourmet southwestern cuisine Blue Corn Waffle & Pancake Mix, Net Wt. 16 oz (453.6 grams), Los Chileros de Nuevo Mexico, PO Box 6215, Santa Fe, NM 87502 BWPB sold between 4/21/13 to 10/21/14 Class II Los Chileros De Nuevo Mexico is conducting a field action for Blue Corn Waffle & Pancake Mix (BWPB), Sopaipilla Mix (SOPP), Santa Fe Chile Seasoning (SFCS), Green Chile Blue Cornbread (GCBB), Cream of Green Chile Chicken Soup (GCCS), Green Chile Stew with Tortilla Mix (GCSB) and Carne Adovada with Sopaipilla Mix (CADB) due to undeclared wheat. Los Chileros De Nuevo Mexico, LTD
Food Los Chileros de nuevo mexico gourmet southwestern cuisine Sopaipilla Mix, Net Wt. 12 oz (340 grams), Los Chileros de Nuevo Mexico, PO Box 6215, Santa Fe, NM 87502 All products sold between 4/21/13 to 10/21/14 Class II Los Chileros De Nuevo Mexico is conducting a field action for Blue Corn Waffle & Pancake Mix (BWPB), Sopaipilla Mix (SOPP), Santa Fe Chile Seasoning (SFCS), Green Chile Blue Cornbread (GCBB), Cream of Green Chile Chicken Soup (GCCS), Green Chile Stew with Tortilla Mix (GCSB) and Carne Adovada with Sopaipilla Mix (CADB) due to undeclared wheat. Los Chileros De Nuevo Mexico, LTD
Food Los Chileros de nuevo mexico gourmet southwestern cuisine Santa Fe Chile Seasoning, 4.5oz (127.6 grams), Los Chileros de Nuevo Mexico, PO Box 6215, Santa Fe, NM 87502 All products sold between 4/21/13 to 10/21/14 Class II Los Chileros De Nuevo Mexico is conducting a field action for Blue Corn Waffle & Pancake Mix (BWPB), Sopaipilla Mix (SOPP), Santa Fe Chile Seasoning (SFCS), Green Chile Blue Cornbread (GCBB), Cream of Green Chile Chicken Soup (GCCS), Green Chile Stew with Tortilla Mix (GCSB) and Carne Adovada with Sopaipilla Mix (CADB) due to undeclared wheat. Los Chileros De Nuevo Mexico, LTD
Food Los Chileros de nuevo mexico gourmet southwestern cuisine Green Chile Blue Cornbread, 9.84 oz., Los Chileros de Nuevo Mexico, PO Box 6215, Santa Fe, NM 87502 All products sold between 4/21/13 to 10/21/14 Class II Los Chileros De Nuevo Mexico is conducting a field action for Blue Corn Waffle & Pancake Mix (BWPB), Sopaipilla Mix (SOPP), Santa Fe Chile Seasoning (SFCS), Green Chile Blue Cornbread (GCBB), Cream of Green Chile Chicken Soup (GCCS), Green Chile Stew with Tortilla Mix (GCSB) and Carne Adovada with Sopaipilla Mix (CADB) due to undeclared wheat. Los Chileros De Nuevo Mexico, LTD
Food Los Chileros de nuevo mexico gourmet southwestern cuisine Carne Adovada with Sopaipilla Mix, 13 oz.., Los Chileros de Nuevo Mexico, PO Box 6215, Santa Fe, NM 87502 All products sold between 4/21/13 to 10/21/14 Class II Los Chileros De Nuevo Mexico is conducting a field action for Blue Corn Waffle & Pancake Mix (BWPB), Sopaipilla Mix (SOPP), Santa Fe Chile Seasoning (SFCS), Green Chile Blue Cornbread (GCBB), Cream of Green Chile Chicken Soup (GCCS), Green Chile Stew with Tortilla Mix (GCSB) and Carne Adovada with Sopaipilla Mix (CADB) due to undeclared wheat. Los Chileros De Nuevo Mexico, LTD
Food Los Chileros de nuevo mexico gourmet southwestern cuisine Cream of Green Chile Chicken Soup, 5.92 oz.., Los Chileros de Nuevo Mexico, PO Box 6215, Santa Fe, NM 87502 All products sold between 4/21/13 to 10/21/14 Class II Los Chileros De Nuevo Mexico is conducting a field action for Blue Corn Waffle & Pancake Mix (BWPB), Sopaipilla Mix (SOPP), Santa Fe Chile Seasoning (SFCS), Green Chile Blue Cornbread (GCBB), Cream of Green Chile Chicken Soup (GCCS), Green Chile Stew with Tortilla Mix (GCSB) and Carne Adovada with Sopaipilla Mix (CADB) due to undeclared wheat. Los Chileros De Nuevo Mexico, LTD
Food Los Chileros de nuevo mexico gourmet southwestern cuisine Green Chile Stew with Tortilla Mix, 13oz., Los Chileros de Nuevo Mexico, PO Box 6215, Santa Fe, NM 87502 All products sold between 4/21/13 to 10/21/14 Class II Los Chileros De Nuevo Mexico is conducting a field action for Blue Corn Waffle & Pancake Mix (BWPB), Sopaipilla Mix (SOPP), Santa Fe Chile Seasoning (SFCS), Green Chile Blue Cornbread (GCBB), Cream of Green Chile Chicken Soup (GCCS), Green Chile Stew with Tortilla Mix (GCSB) and Carne Adovada with Sopaipilla Mix (CADB) due to undeclared wheat. Los Chileros De Nuevo Mexico, LTD
Devices Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: The Titanium Polyaxial Reduction Head is a part of the Matrix Spine System. Intended for posterior pedicle screw fixation (Tl OS2- ilium), posterior hook fixation (Tl-L5), or anterolateral fixation (T8-L5). Part Number 04.634.002 Lot Number 6816781 Class I Two nonconforming parts of the Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws may have been inadvertently packaged and shipped. It is believed that the inner diameter of the Reduction Head may not have been machined to the correct specification. Synthes, Inc.
Devices Calcitonin ELISA Kit, Code No. 7024, 7024BU. Intended use of this product is the quantitative determination of Calcitonin in human serum. Lot No. 2180, 2178, 2167, 2124, 2089, 2071 and 2041. Class II A potential issue with false high values. Biomerica
Food Alfalfa seed: Organic, Alfalfa, NOP Oregon Tilth, Net Wt. 55 LB, International Specialty Supply SAL1-3BL Class I A sample taken by FDA of one lot of alfalfa seed tested positive for Salmonella International Sprout Holding Inc.
Devices Relief ACP Oral Care Gel intended to relieve discomfort from dentin sensitivity. Sold separately in single, single syringe, 4 packs, 6 packs and in teeth whitening kits - List of Relief ACP Oral Care Gel products distributed in U.S. SKU Number Lot Number PV1602 14111008 PV1602 14127009 PV1609 14141018 - List of Teeth Whitening kits containing Relief ACP Oral Care Gel products distributed in U.S. SKU Number Lot Number ZM2665 14090044 ZM2665 14097026 ZM2665 14104024 ZM2665 14106004 ZM2665 14113035 ZM2665 14121018 ZM2665 14122005 ZM2665 14134020 ZM2666 14104025 ZM2666 14105025 ZM2666 14113028 ZM2666 14118015 ZM2666 14127019 ZM2666 14134030 ZM2666  ...
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Class II Product sold after April 1, 2014 were inadvertently filled with hydrogen peroxide teeth whitening gel (6% concentration as dispensed) on one side of the dual barrel syringe instead of the intended component (phosphate gel). Consequently, use of this product by patients may result in a neutral effect or increased sensitivity. Discus Dental LLC
Food Macadamia nuts in various formats: (1.) Western Family Macadamia Diced Nuts, Net Wt 5 oz. plastic bags Distributed by:Western Family Foods, Inc. Portland, OR UPC 0 15400 16635 5 (2.) Shur Fine Macadamia Diced Nuts, Net Wt 5 oz. plastic bags. Distributed by:Western Family Foods, Inc. Portland, OR UPC 0 15400 86635 4 (3.) HyVee Macadamia Nuts, Net Wt 2 oz. plastic bags. Distributed by:Hy-Vee Inc, West Des Moines Iowa, UPC 0 75450 13287 815400 16635 (4.) market pantry Chopped Macadamia Nuts, Net Wt 2.25 oz. plastic bags. Distributed by:Target Corp., MN, UPC 0 85239 52108 3 (5.) Pears Gourmet Macadamia Nuts Raw, Net Wt 1 LB, plastic bags with gold adhesive label. Distributed by:Marathon Ventures, Bellevue, NE UPC 0 75049 42186 4 (6.) CWD Cash-Wa Distributing, Co. Macadamia Nuts Raw, Net Wt 5 LBS, Distributed by:Cash-Wa Distributing, Co, Kearney, North Platte and Sidney, NE (7.) Macadamia Nuts Raw, Net Wt 5 LBS, Distributed by:Pegler Sysco, Lincoln, NE (8.) Bulk Case Mayan Gold Macadamia Nuts Style #5, Net Wt 25 LBS, Distributed by:Marathon Ventures, Bellevue, NE. Macadamia nuts in various formats: (1.) "Western Family" Best  ...
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Class I Macadamia nuts may have possible contamination with Salmonella florida. Marathon Ventures Inc
Devices Cannulaide, Model 101, 102, 103. The Cannulaide product is composed of die-cut hydrocolloid-coated polyurethane film with an integral hook strip (i.e., Velcro) to allow for the use of a loop material to help secure a nasal interface. The Cannulaide is applied under and over the nose of infants to provide a protective barrier to the philtrum, columella, septum, nares, and tip of nose. It is available in multiple sizes that vary the external geometry and nare hole size and spacing to allow for use on infants ranging from less than 700 grams to greater than 3000 grams. It is a non-sterile, single patient use, disposable device. CA 101: Lot 54219; CA 102: Lot 52834; CA 103: Lot 53813; Class II Cannulaide recalled May 2008 due to improper seal of the pouch. Beevers Manufacturing & Supply, Inc.
Devices Remel TB Potassium Permanganate (.5% Aqueous) 40192, packaged in 250 ml bottles, 5/pkg. A stain for use in qualitative procedures as a counterstain in the fluorescent microscopic detection of mycobacteria. Lot: 293086 Expiration 01Apr2015 Class II The product may appear cloudy or discolored and may not perform correctly in presumptive diagnosis of mycobacterial disease. Remel Inc
Devices The J700 Floor Mounted Tube Stand (FMTS) is intended to support and position the diagnostic x-ray tube housing assembly for a medical radiographic procedure. The product consists of a vertical column (with counterbalanced vertical carriage, counterweight and pulley system), horizontal floor car and a floor mounted track to ride on. Model Numbers: J700-01, J700-02, J700-03, J700-04 Class II The welds on J700 tube stands may be insufficient resulting in tube stand breakage, damage to the X-Ray machine, and/or patient or healthcare provider injury. Summit Industries Inc.
Devices Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur adn Tibia) is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. 00-5970-000-25 JTOMA-JL-0636-L8 Pin Guide LOT#: 56602902 Class II The box of guides for case JTOMA-JL-0636-L contained two (2) femoral guides instead of one (1) femoral guide and one (1) tibial guide. The device did not meet specification: One tibia guide missing and one femur guide contained an edge which was +0.04 mm over specification. Materialise USA LLC
Drugs Heparin Sodium in 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container Lot #: N003061; N003079; and N003087. Class II Subpotent Drug: Heparin raw material was found to have low potency Baxter Healthcare Corporation
Devices CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft ). Box of 5 Model Number(s): R2010 Intended Use: Diagnosis and treatment of non-invasive HPV-related or unrelated lesions of the lower genital tract. Lot 159621 Exp Date: 2017-05 Class II Outer box is mislabeled as P/N R2010- Large Radius Loop Electrode instead of P/N R1010- Medium Radius Loop Electrode CooperSurgical, Inc.
Devices 8MM,POTTS SCISSORS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Part number: 470001-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings. Class II Deviations in reprocessing steps from those stated in the reprocessing instructions, can cause surface degradation of the housing; and/or, accelerate mechanical wear of the instrument. Intuitive Surgical, Inc.
Devices 8MM,LARGE NEEDLE DRIVER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Part number: 470006-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings. Class II Deviations in reprocessing steps from those stated in the reprocessing instructions, can cause surface degradation of the housing; and/or, accelerate mechanical wear of the instrument. Intuitive Surgical, Inc.
Devices 8MM,BLACK DIAMOND MICRO FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Part number: 470033-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings. Class II Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument. Intuitive Surgical, Inc.
Devices 8MM,LONG TIP FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Part number:470093-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings. Class II Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument. Intuitive Surgical, Inc.
Devices 8MM,MICRO BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Part number: 470171-05; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings. Class II Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument. Intuitive Surgical, Inc.
Devices 8MM,PROGRASP FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Part number: 470093-04 ; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings. Class II Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument. Intuitive Surgical, Inc.
Devices 8MM,MARYLAND BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Part number: 470172-05; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings. Class II Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument. Intuitive Surgical, Inc.
Devices 8MM MONOPOLAR CURVED SCISSORS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Part number: 470179-04 All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings. Class II Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument. Intuitive Surgical, Inc.
Devices 8MM RESANO FORCEPS,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Part number: 470181-04 ; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings. Class II Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument. Intuitive Surgical, Inc.
Devices 8MM PERMANENT CAUTERY HOOK,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Part number:470183-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings. Class II Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument. Intuitive Surgical, Inc.
Devices 8MM PERMANENT CAUTERY SPATULA,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Part number 470184-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings. Class II Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument. Intuitive Surgical, Inc.
Devices 8MM FENESTRATED BIPOLAR FORCEPS,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Part number 470205-05; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings. Class II Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument. Intuitive Surgical, Inc.
Devices 8MM, TENACULUM FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Part number; 470207-04 All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings. Class II Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument. Intuitive Surgical, Inc.
Devices 8MM, CARDIAC PROBE GRASPER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Part number;470215-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings. Class II Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument. Intuitive Surgical, Inc.
Devices 8MM, LARGE HEM-O-LOK CLIP APPLIER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Part number; 470230-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings. Class II Intuitive Surgical, Inc.
Devices 8MM, ATRIAL RETRACTOR SHORT RIGHT ; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Part number; 470246-04 ; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings. Class II Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument. Intuitive Surgical, Inc.
Devices 8MM, DUAL BLADE RETRACTOR; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Part number; 470249-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings. Class II Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument. Intuitive Surgical, Inc.
Devices 8MM, MEGA SUTURECUT ND; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Part number; 470309-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings. Class II Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument. Intuitive Surgical, Inc.
Devices 8MM, SMALL GRASPING RETRACTOR ; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Part number; 470318-04 ; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings. Class II Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument. Intuitive Surgical, Inc.
Devices 8MM,MEDIUM-LARGE CLIP APPLIER ; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Part number; 470327-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings. Class II Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument. Intuitive Surgical, Inc.
Devices 8MM, CURVED BIPOLAR DISSECTOR; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Part number; 470344-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings. Class II Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument. Intuitive Surgical, Inc.
Devices 8MM, TIP-UP FENESTRATED GRASPER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Part number; 470347-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings. Class II Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument. Intuitive Surgical, Inc.
Devices GDC-10 360 SOFT 3mm x 6cm SR ; GDC 360° Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's general medical condition - are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques, or( b) inoperable Model M003347306SRO, Lot number: 14467382; Exp. May 2014. Class II Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date. Stryker Neurovascular
Devices GDC-10 360 10mm x 30cm SR ; GDC 360° Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's general medical condition - are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques, or b) inoperable Model M0033461030SRO, Lot number: 13239506; Exp. Jan 2013. Class II Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date. Stryker Neurovascular
Devices GDC-18 360 20mm x 33cm ; GDC 360° Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's general medical condition - are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques, or b) inoperable Model M00334820330, Lot number: 12881100; Exp. Jul 2012. Class II Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date. Stryker Neurovascular
Devices Target 360 Standard 12mm x 30cm; Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. Target Detachable Coils are indicated for endovascular embolization of: " Intracranial aneurysms " Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae " Arterial and venous embolizations in the peripheral vasculature Model M0035461230, Lot number: 13817326; Exp. Oct 2013. Class II Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date. Stryker Neurovascular
Devices Gateway OTW 2.75mm x 9mm; The Gateway PTA balloon catheter is indicated for balloon dilation of the stenotic portion of intracranial arteries for the purpose of improving intracranial perfusion. Model M00320072209270, Lot number: 12693091; Exp. Jun 2012. Class II Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date. Stryker Neurovascular
Drugs Testosterone CYP-250/PROP-20 mg, 10 Ml Syringe, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-0326-44 141006HH, 11/6/14 Class II Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Perry Drug Inc.
Drugs Methyl B12 25 mg/mL Inj., 10 Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-2014-37 141006GG, 11/6/14; 141009FF, 11/9/14; 141014BB, 11/9/14; 141014BB, 11/14/14; 1410164, 11/16/14; 141021GG, 11/21/14; 141030DD, 11/30/14 Class II Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Perry Drug Inc.
Drugs Tri-Mix (PGE-10MCG/PAP-30MG/PT 5Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5123-09 141008BB, 11/8/14; 141008CC, 11/8/14; 141010G, 11/10/14; 141010J, 11/10/14; 141010K, 11/10/14; 141013GG, 11/13/14; 141015DD, 11/15/14; 141015BB, 11/15/14; 141020GG, 11/20/14; 141024HH, 11/24/14; 141024II, 11/24/14; 141024JJ, 11/24/14; 141028BB, 11/28/14; 141028CC, 11/28/14; 141031GG, 12/1/14; Class II Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Perry Drug Inc.
Drugs Leuprolide 50 mcg/0.1 mL Micro Lupron Kit, 5Ml, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-1124-57 141007DD, 11/7/14; 141015GG, 11/15/14; 141031II, 12/1/2014; 141031AA, 11/31/14; 141031JJ, 12/1/14; Class II Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Perry Drug Inc.
Drugs Phenylephrine HCl (100 mcg/mL syr) in 0.9% NaCl 1 mg / 10 mL, 3Ml Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5230-12 141008AA, 11/8/14; 141017E, 11/17/14; 141030EE, 11/30/14 Class II Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Perry Drug Inc.
Drugs Testosterone Cyp 200 mg/mL Sesame Inj., 4Ml Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-7906-71 141013DD, 11/13/14 Class II Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Perry Drug Inc.
Drugs HCG Low Dose 30 IU/0.1 mL, 5 Ml vial, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-0231-54 141009DD, 11/9/14 Class II Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Perry Drug Inc.
Drugs Tri-mix Antidote 10 each Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-0205-17 141010K, 11/10/14 Class II Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Perry Drug Inc.
Drugs HCG Low Dose 10 IU / 0.1 mL, 5 Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS ---NDC 88888-2596-17 141010I, 11/10/14; 141017F, 11/17/14; Class II Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Perry Drug Inc.
Drugs HCG 200 IU/mL Injection, 30Ml, 10 mL vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-7745-68 141015DD, 11/15/14 Class II Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Perry Drug Inc.
Drugs HCG 10,000 U/ 10 mL PF Inj, 8Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5012-34 141015FF, 11/15/14; 141024KK, 11/24/14; 141031CC, 12/1/14 Class II Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Perry Drug Inc.
Drugs 2Ml HCG 10,000 U/ MB12 - 12,000 MCG/10 Ml Inj, 0.25ML (250IU), Rx, Perry Drug Compounding Pharmacy, Overland Park, KS ---NDC 88888-7945-17 141016A, 11/16/14 Class II Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Perry Drug Inc.
Drugs Cyclosporine 0.045 % Sol PF, 12 mL bottle, Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5120-67 141013CC, 11/13/14 Class II Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Perry Drug Inc.
Drugs HCG-20,000 U/2 mL Vial, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS ---NDC 88888-2195-47 141021DD, 11/21/14; Class II Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Perry Drug Inc.
Drugs Tri Mix PF SYR 0.5 mL Inj., Compounded Rx, 10 each, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5036-49 141021FF, 11/21/14; 141028CC, 11/28/14 Class II Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Perry Drug Inc.
Drugs HCG - 10,000 Unit PF Inject, 1mL Syringe, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS NDC 88888-0216-49 141021CC, 11/21/14 Class II Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Perry Drug Inc.
Drugs Sodium Tetradecyl SO4 0.3% Inj., 30 Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-6427-90 141030FF, 11/30/14 Class II Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Perry Drug Inc.
Drugs Amlodipine Besylate Tablets, USP 10 mg, Rx Only, 90 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-123-16 Lot #: MP4344, Exp 04/2016 Class III Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344. Zydus Pharmaceuticals USA Inc
Food Alfalfa Seed in plastic lined bags labeled in part *** VNS Alfalfa, NET WT. 25 KG Lot SAL2-3BJ Product of AUSTRALIA, International Specialty Supply *** SAL2-3BJ Class I A sample of one lot of product tested positive for salmonella. International Sprout Holding Inc.
Devices Esprit V1000 Ventilator, Model No. V1000 and Esprit/V200 Conversions The Esprit V1 000 and EspriW200 Conversion Ventilators are microprocessor-controlled, electrically powered mechanical ventilators. Intended for use by medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients. All Esprit V1000 ventilators manufactured prior to December 31, 2004 and those units manufactured prior to 12/2004 that have been converted to V200. Class II If the power supply fan mounting screws are installed incorrectly, the ends of the screws may touch the power supply printed circuit board assembly (PCBA) and short to ground. This may prevent the ventilator to switch to battery power if AC power is disrupted.. Respironics California Inc
Devices 7F NeuroFlo Catheter, Model 1027 The NeuroFlo Catheter is a multi-lumen device with two balloons mounted near the distal tip for the treatment of cerebral ischemia resulting from symptomatic vasospasm following aneurysmal subarachnoid hemorrhage. The NeuroFlo Catheter is under Humanitarian Device Exemption and not commercially released under a premarket notification or premarket approval. Model 1027, Catalog number 8700-000775-01, lot 0021. Class II After aquisition of assets of CoAxia, Zoll discovered that one lot of NeuroFlo Catheters was manufactured by another firm and an HDE supplement listing as the owner of the product was not filed. ZOLL Circulation, Inc.
Devices Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE TSX-301C X-ray CT system with a 320-row 0.5 mm detector is provided with a 7.5-MHU large-capacity X-ray tube unit, and permits scanning over large areas at the high-speed of 0.35 s per rotation. The system features are; 160-mm-wide area detector, station, gantry and patient couch operation controls, image reconstruction, high-speed volume scan, high-quality images, selectable image slice thickness, dual-monitor system, improved image diagnosis functions, high-speed volume data workflow, exposure reduction, ECG-gated scan and reconstruction, and SUREFluoro. The CT cardiac function analysis software is used to analyze cardiac function using data obtained by performing cardiac MPR processing for ECG-gated scan data according to the cardiac axis. Aquilion ONE is a dynamic volume CT system that supports whole-body scanning. This 320-detector row system generates 640 slices per rotation using the coneXact reconstruction algorithm. In addition, the high-speed rotation mechanism and the fast reconstruction unit of the system allow the rapid image acquisition to further improve throughput in CT examinations. Item CFA Software Serial Number: Description TSX-301C/2D 2BA1362093 Aquilion One Vision Class II This recalled is being issued due to a potential problem with the cardiac function analysis software (CFA). It has been found that, due to the problem with the software, incorrect analysis results may be displayed in the Function Parameters for the Entire Heart displayed as analysis results of the CFA and in a Left-Ventricular Volume Curve generated based on some of those parameters. Toshiba American Medical Systems Inc
Devices Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE TSX-301A/2D X-ray CT system with a 320-row 0.5 mm detector is provided with a 7.5-MHU large-capacity X-ray tube unit, and permits scanning over large areas at the high-speed of 0.35 s per rotation. The system features are; 160-mm-wide area detector, station, gantry and patient couch operation controls, image reconstruction, high-speed volume scan, high-quality images, selectable image slice thickness, dual-monitor system, improved image diagnosis functions, high-speed volume data workflow, exposure reduction, ECG-gated scan and reconstruction, and SUREFluoro. Item CFA Software Serial Number: Description TSX-301A/2D 1BA07X2002 Aquilion One TSX-301A/2D 1BA07X2001 Aquilion One Class II This recalled is being issued due to a potential problem with the cardiac function analysis software (CFA). It has been found that, due to the problem with the software, incorrect analysis results may be displayed in the Function Parameters for the Entire Heart displayed as analysis results of the CFA and in a Left-Ventricular Volume Curve generated based on some of those parameters. Toshiba American Medical Systems Inc
Food Frozen Raw Yellowfin Tuna Ground Meat (Thunnus albacares), Grade: AAA, Net Weight: 10 lbs (100%), Wild Caught, Product of Indonesia, Imported and distributed by Heartlight Seafood LLC, 429 SW 195th Ave., Pembroke Pines, FL 33029, Production Date: 06/10/2014, Best used by 06/10/2016, UPC 207935110006 Lot #128578 Class II Sushi House Inc. is conducting a voluntary recall of Heartlight Ground Tuna because it may contain histamines which exceed 50 ppm. SUSHI HOUSE INC.
Food Organic Brown Rice Flour; 25 lb. bulk bags Organic Brown Rice Flour ( UPC # 073416 00500 6) were distributed in retail store bulk bins. Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems if consumed raw. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. lot # 141027 exp. 10/27/2015 lot # 141028, exp. 10/28/2015 Lot # 141029 exp. 10/29/2015 . Sold between November 4 and November 12, 2014. Class I Customer notified Lundberg Family Farms of a positive Salmonella test on Organic Brown Rice Flour. Wehah Farms
Food Eco Farm Fine Brown Rice Flour; 25 lb. bulk bags Organic Brown Rice Flour ( UPC # 073416 00500 1) were distributed in retail store bulk bins. Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems if consumed raw. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. Lundberg Family Farms, Richvale, CA lot # 141029 exp. 10/29/2015; Lot # 141030 exp. 10/30/2015 . Sold between November 4 and November 12, 2014. Class I Customer notified Lundberg Family Farms of a positive Salmonella test on Organic Brown Rice Flour. Wehah Farms
Devices BrightView product code: 882478 BrightView X product code: 882480 BrightView XCT product code: 882482 and 882454 BrightView: 11000022, 11000028, 11000050, 1000067, 11000070, 11000073, 1000079, 11000080, 11000084, 11000088, and 11000109. BrightView X:4000007, 4000034, 4000045, 4000049, 4000050, 4000052, 4000055, 4000057, 4000062, 4000091, 4000110, 4000119, 4000145, 4000178, 4000186, 4000192, 4000203, 4000215, 4000221, 4000234, 4000267, 4000268, 4000273, 4000315, 4000332, 4000335, 4000337, 4000340, 4000343, 4000349, 4000351, 4000359, 4000391, 4000404, 4000436, 4000447, 4000493,  ...
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Class II Software issues Philips Medical Systems (Cleveland) Inc
Devices IntelliSpace Portal DX/HX/EX model number: 881001 IntelliSpace Portal DX/HX/EX Upgrade model number: 881011 IntelliSpace Portal DX/HX/EX Demo model number: 881012 IntelliSpace Portal IX model number; 881030 IntelliSpace Portal DX/HX/EX: 96027,96029,96025,96030,96031,85479,79935, 98087,85175,96024,106013,450003, 950002, 950003,35009,35030,870056, 550012, 85081, 97069, 45001985333, 35036, and 85382. IntelliSpace Portal DX/HX/EX Upgrade: 950100, 55003, and 81178. IntelliSpace Portal DX/HX/EX Demo: 85451 and 87290. IntelliSpace Portal  ...
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Class II Software defect Philips Medical Systems (Cleveland) Inc
Devices LUNA Chest, Model No. LU4006 Kit Lot Numbers: 13116, 14012, 14017, 14056, 14074, 14103, 14107 Drape Lot Numbers: D132172, D132602, D162692, D132602, D132712, D141002, D130282 Class III Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label. Novadaq Technologies, Inc.
Devices Non-sterile drape Kit Lot Numbers: 14082, 14091, 14104, 14106 Drape Lot Numbers: D132712, D133102, D141022, D130282 Class III Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label. Novadaq Technologies, Inc.
Food Karlsburger Foods Taco Seasoning, Item Numbers 43823 (Packaged in 23 oz resealable plastic containers), Item #43807 (Packaged in 7 lb. resealable plastic containers), Item #43825 (Packaged in 25 lb. bag in a box), and Item #43850 (Packaged in 50 lb. bag in a box). Item Numbers 43823, 43807, 43825, and 43850. Class I Taco Seasoning has an allergen of milk in the product that is not declared on the label. Karlsburger Foods, Inc.
Food Karlsburger Foods Low Sodium Taco Seasoning, Item Numbers 16423 (Packaged in 23 oz resealable plastic containers), Item #16465 (Packaged in 6.8 lb. resealable plastic containers), and Item #16425 (Packaged in 25 lb. bag in a box). Item Numbers 16423, 16465, and 16425. Class I Taco Seasoning has an allergen of milk in the product that is not declared on the label. Karlsburger Foods, Inc.
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