• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of December 5, 2012

  • Print
  • Share
  • E-mail
-
Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Red Blood Cells C85832 Class II Blood product, which was collected from a donor who traveled to malarial endemic areas, was distributed. Mississippi Valley Reg Bld Ctr
Biologics Red Blood Cells Leukocytes Reduced LR07481 Class II Blood products, which were collected from a donor who traveled to malarial endemic areas, were distributed. Mississippi Valley Reg Bld Ctr
Biologics Red Blood Cells Leukocytes Reduced Irradiated LR06314 Class II Blood products, which were collected from a donor who traveled to malarial endemic areas, were distributed. Mississippi Valley Reg Bld Ctr
Biologics Source Plasma 07OUTE7481; 07OUTE6595; 07OUTE5995; 07OUTE5440; 07OUTE3268; 07OUTE2865; 07OUTE1483; 07OUTE1041; 07OUTD9210; 07OUTD8745; 07OUTD8184; 07OUTD7577; 07OUTD6988; 07OUTD6075; 07OUTD5854; 07OUTD0584; 07OUTC7070; 07OUTC6440; 07OUTC1645; 07OUTC2199; 07OUTC3461; 07OUTC3772; 07OUTC4978; 07OUTC5334; 07OUTC5999 Class II Blood products, which were collected from a donor in which donor suitability were not adequately determined, were distributed. BioLife Plasma Services L.P.
Biologics Source Plasma 07OUTF1661; 07OUTF2092; 07OUTF3219; 08OUTF2071; 08OUTF4413; 08OUTF5051; 08OUTF5772; 08OUTF6290; 08OUTF6931; 07OUTF4170; 07OUTF4787; 2473; 08OUTF7761; 08OUTF8282 Class III Blood products, which were collected from a donor in which donor suitability were not adequately determined, were distributed. BioLife Plasma Services L.P.
Biologics Source Plasma 07IMOD8365; 07IMOD8086; 07IMOD9626; 08IMOC2350; 08IMOC1236; 08IMOC0517; 08IMOB9411; 08IMOA7165; 07IMOF2982; 07IMOF1494; 07IMOE8541; 07IMOE8131; 07IMOE7029; 07IMOE5551; 07IMOE4790; 07IMOE2580; 07IMOE1607; 07IMOD9837; 07IMOD2723; 07IMOD3620; 07IMOD4070; 07IMOD5186; 07IMOD5575; 07IMOD6637; 07IMOD6938 Class II Blood products, collected from a donor who did not have a complete physical examination, were distributed. BioLife Plasma Services L.P.
Biologics Source Plasma 0120670922; 0120670420; 0120669623; 0120669233; 0120668631; 0120666057; 0120664300; 0120663873; 0120662673; 0120661633; 0120660951; 0120660581; 0120660044; 0120659556; 0120658867; 0120658422; 0120657338; 0120657046; 0120656310; 0120655992; 0120651739; 0120651008; 0120650195; 0120649474; 0120648612; 0120648062; 0120647087; 0120646615; 0120645595; 0120645206; 0120644218; 0120643550; 0120637632; 0120635366; 0120634217; 0120633574; 0120632409; 0120631978; 0120630408; 0120629596; 0120628386; 0120627877; 0120626800; 0120626336; 0120624193; 0120623705; 0120622656; 0120622229; 0120621101; 0120620702; 0120619738; 0120619204; 0120618173; 0120617647; 0120616569; 0120615589; 0120614950; 0120614086; 0120613388; 0120611482; 0120611242. Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. CSL Plasma, Inc.
Biologics Source Plasma 0111149111; 0111147834; 0111146858; 0111145398; 0111144544; 0111140295; 0111139418; 0111137586; 0111136853; 0111135164; 0111132473; 0111110562; 0111108783; 0111108007; 0111105480; 0111104143; 0111103129; 0111101609; 0111100446; 0111098621; 0111097833; 0111096140; 0111094912; 0111093305; 0111092212; 0111090898; 0111089695; 0111086002; 0111084770; 0111083520; 0111082406; 0111081158; 0111079979; 0111078736; 8750013927; 8750012649; 8750011299; 8750009785; 8750008278; 8750007210; 8750005857; 8750003894; 8750000361; 0111072791; 0111070491; 0111069856; 0111066340; 0111065204; 0111062461; 0111061817; 0111057970; 0111056553; 0111053550; 0111052886. Class II Blood products, which were collected from a donor in which donor suitability were not adequately determined, were distributed CSL Plasma, Inc.
Devices Medpro Elastomeric Infusion Pump. AccuFlux, Model # CT-0020-100H. Product Usage: The devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications. It is the responsibility of the user to ensure that the medication is prepared and administered accordance with the drug manufacturers package insert. The devices deliver controlled amounts of medication directly to the intraoperative site for pain management and or antibiotic administration. The devices infuse the medication at an hourly flow rate. Medications are infused intraoperatively and postoperatively through intramuscular or subcutaneous routes. The devices are also intended for controlled delivery of local anesthetics in close proximity to nerves for post operative regional anesthesia and pain management. Routes of administration may be intraoperative or percutaneous. It is for continuous infusion of medications for general infusion use, including antibiotic delivery and chemotherapy. AccuFlux, Lot#: 91209. Class I Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being reclassified by the Agency as a Class I. The recall was initiated because First Medical Source has confirmed that these lots may have a higher flow rate than specified. The use of this product may lead to over-administration of drug solutions to the patients. The product may fail to meet nominal flow rate of ±15%. First Medical Source LLC
Food Mercer's Ice Cream Old Fashioned Cookie Dough, Half Gallon, (1.89 Liter), UPC 036667 200231 1243, 1236, 1208, 1224, 1203, 1214 Class II The ice cream product contained soy lecithin (the ingredient statement listed lecithin only). Quality Dairy Farms Inc.
Food Mercer's Ice Cream Cookies 'N Cream, Half Gallon (1.89 Liter), UPC 036667 200392 1243, 1236, 1208, 1224, 1203, 1214 Class II The ice cream product contained soy lecithin (the ingredient statement listed lecithin only). Quality Dairy Farms Inc.
Food Mercer's Ice Cream Cream N' Coffee Fudge, Half Gallon, (1.89 Liter), UPC 074513 003513 1243, 1236, 1208, 1224, 1203, 1214 Class II The ice cream product contained soy lecithin (the ingredient statement listed lecithin only). Quality Dairy Farms Inc.
Devices IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com; Customer Service: 888.499.0079 The X-Post Reamer is an accessory to the IO FiX Screw and Washer System that is used for reaming bone most common to orthopedic surgical procedures. Product coding is listed as Catalog Number: Lot Number and are as follows: 118-0005:126564; 118-30016:127375; 118-30018:AP6A08; 118-30020:AP6A07. Class II Product Event Reports revealed a broken reamer experienced intra-operatively. Pre-drilling was not performed prior to reaming. Extremity Medical LLC
Biologics Red Blood Cells Washed W11631271022400; Class III Blood product, which was washed with an incorrect wash solution, was distributed. Florida Blood Services, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W035812021588; W035812021588; W035811150375; W035811074394; W035811060067; W035810379496; W035810403681; Class II Blood products, collected from a donor who was permanently deferred, were distributed. BloodSource, Inc.
Biologics Platelets Pheresis Leukocytes Reduced W035812006969; W035811150375; W035811074394; W035811074394; W035811060067; W035810379496; W035810403681; Class II Blood products, collected from a donor who was permanently deferred, were distributed. BloodSource, Inc.
Biologics Red Blood Cells Leukocytes Reduced W035812006758; W035810322840; W035810321291; W035809206091; W035809227265; W035809124885; Class II Blood products, collected from a donor who was permanently deferred, were distributed. BloodSource, Inc.
Biologics Blood and Blood Products for Reprocessing W036512069578; Class III Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed. LifeShare Blood Centers
Biologics Platelets Pheresis Leukocytes Reduced W115112219699*; Class II Blood product, which did not meet acceptable product specifications, was distributed. LifeSouth Community Blood Centers Inc - Birmingham Region
Biologics Platelets Pheresis Leukocytes Reduced W1151122175155; Class II Blood product, which did not meet the acceptable product specifications, was distributed. LifeSouth Community Blood Centers Inc
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W0470121985440 (Part A); W0470121985440(Part B) Class II Blood products, for which quality control and distribution of products did not meet specifications, were distributed. New York Blood Center, Inc.
Biologics Red Blood Cells Leukocytes Reduced W036212407825; Class II Blood products, which were collected from a donor who gave history which warranted deferral or follow up, were distributed. Belle Bonfils Memorial Blood Center
Biologics Plasma Frozen within 24 hours (FP24) W036212402329; Class II Blood products, which were collected from a donor who gave history which warranted deferral or follow up, were distributed. Belle Bonfils Memorial Blood Center
Drugs Reumofan Plus Tablets, 30-count bottle per Box, (remaining label information in Spanish) all lots within expiry through 2016 Class I Marketed without an approved NDA/ANDA: Samantha Lynn Inc. is recalling Reumofan Plus Tablets because it contains undeclared drug ingredients making it an unapproved drug. Samantha Lynn, Inc
Biologics Red Blood Cells Leukocytes Reduced Irradiated W036810136115(Part A); W036810136115(Part B) Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells 8486241; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Fresh Frozen Plasma 8486241; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells Leukocytes Reduced W120612090715; Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. Michigan Blood
Devices GE Healthcare Optima XR 220amx 30kw Mobile X-ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireless Detector, which is intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR). Model No - 5555000-5 Class II GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima XR22Oamx and Optima XR200amx with Digital Upgrade. GE Healthcare, LLC
Devices GE Healthcare Optima XR 220amx 15kw Mobile X-Ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireless Detector, which is intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR). Model No - 5555000-6 Class II GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima XR22Oamx and Optima XR200amx with Digital Upgrade. GE Healthcare, LLC
Devices GE Healthcare Optima XR 200 amx with Digital Upgrade. The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireless Detector, which is intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR). Model No - 5421698 Class II GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima XR22Oamx and Optima XR200amx with Digital Upgrade. GE Healthcare, LLC
Devices Devices includes a Multi Port Inflator or without Multi Port Inflator (MPI). All the devices are vascular blood flow machines. Devices are distributed with pressure cuffs of varying sizes as accessories. Affected models include *2100-SX, 3000 series, 2017, 2016, 2015, 2014, 1059, 1059-A, *1059-C, *1058-C, 4000 series, 1100 series, 1060 series, 1080 series, 234 and 246. (* = current production model) All the devices are used in the study and diagnosis of vascular disease and blockages in the upper and lower extremities. Domestic Distribution: 013053, 013104, 013107, 013124, 013154, 013182, 013193, 014203, 014237, 014248, 014249, 014252, 014253, 014254, 014269, 014276, 014310, 014335, 014339, 014361, 014366, 014376, 014380, 014381, 014382, 014384, 014397, 014401, 014406, 014416, 014424, 014429, 014431, 014443, 014444, 014448, 014454, 014458, 014530, 014532, 014533, 014540, 014542, 014545, 014547, 014551, 014552, 014552, 014553, 014598, 014601, 014604, 014608, 014616, 014654, 014657, 014659, 014660, 014661, 014663, 103077, 105X-600001024, 105X-600001025, 105X-600001026, 105X-600001027, 105X-800001019, 105X-800001022, 105X-800001023, 105X-800001024, 105X-800001026, 105X-800001027, 105X-800001027, 105X-800001028, 105X-800001029, 105X-800001030, 105X-800001031, 105X-E00001001, 105X-E00001002, 105X-E00001003, 105X-E00001004, 105X-E00001005, 105X-E00001007, 105X-E00001008, 105X-E00001009, 105X-E00001010, 105X-E00001011, 105X-E00001012, 105X-E00001013, 105X-E00001014, 105X-E00001016, 105X-E00001017, 105X-E00001018, 105X-E00001019, 105X-E00001020, 105X-F00001000, 105X-F00001001, 105X-F00001002, 105X-F00001003, 105X-F00001004, 105X-F00001005, 105X-F00001005, 105X-F00001006, 105X-F00001007, 105X-F00001008, 105X-F00001009, 105X-F00001010, 105X-F00001011, 105X-F00001012, 105X-F00001013, 105X-F00001014, 105X-F00001015, 105X-F00001016, 105X-F00001017, 105X-F00001018, 105X-F00001020, 105X-F00001021, 105X-F00001022, 105X-F00001023. There are also devices that pre-dated bar codes, as well as devices with unknown codes that the firm is unable to identify. Foreign distribution: 01301, 013043, 013044, 013045, 013046, 013072, 013076, 013175, 013181, 013183, 013188, 014215, 014386, 014392, 014393, 014456, 014535, 014550, 014551, 014561, 014562, 014563, 105X-800001025, 105X-922001017, 105X-922001018, 105X-922001019, 105X-922001021, 105X-9221020, 105X-923001001, 105X-923001002, 105X-923001003, 105X-923001004, 105X-923001005, 105X-923001006, 105X-923001007, 105X-923001007, 105X-923001009, 105X-923001010, 105X-923001011, 105X-E00001000, 105X-E00001003, 105X-E00001006, 105X-E00001015, 105X-F00001019. There are also devices that pre-dated bar codes, as well as devices with unknown codes that the firm is unable to identify. Class II Parks Medical Electronics, Inc. was made aware of two incidents where an air supply tube from their PARKS PVR unit was inadvertently connected to an IV in the patient's arm instead of into the blood pressure cuff. Parks Medical Electronics, Inc
Devices The Is-anti-Sm test kits****Catalog No: 720-240*** Product Usage: The Diamedix Is-anti-Sm Test Kit is an EIA procedure intended for the detection and semi-quantitation of antibodies against the Sm antigen in serum as an aid in the diagnosis of autoimmune disease. The results are reported in ELISA units (EU) per ml determined by comparison to a Calibrator. Catalog # 720-240, Lot # T0401, Expiration Date: November 18. 2012 Class II Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering high out of specification. Diamedix Corporation
Food Nestle Coffee-Mate Coffee Creamer, Original Flavor, packaged as 3/8 fl oz single serve tubs.50 single serve tubs are packaged in a self dispensing fiberboard box. Four fiberboard boxes are packaged in a case. UPC code on the 50 count box: 50000-351107. A production code on the 50 count box: 214651186 with a time stamp from 2:30 to 3:34. Best buy date on 50 count box: Mar 2013 Class II Nestle Professional Vitality initiated a recall on 10/9/12 of their Nestle COFFEE-MATE Original Liquid Creamer Singles due to a manufacturing error that causes the creamer to become acidic. Nestle Professional
Food "Sazon con Culantro y Achiote" (seasoning) 100917, 100920, 101110, 101201, 110120, 110503, 110624, 110802, 120224, 120330, 120612, 120821, 120924 Class II Undeclared colors: FD&C Yellow #5, Yellow#6 and Red #40 Gasco Industrial
Food Gluten Free Cafe Cinnamon Sesame Bar. The Retail Carton has a UPC 70795-03451 and the Individual Bar has a UPC 70795-03551. The product is labeled in parts: "***Cinnamon Sesame Bars With Flax Seeds & Roasted Peanuts***gluten free cafe***NET WT .95 OZ (27g); myglutenfreecafe.com; glutenfreechoices.com Best By dates: 16APR13 BU1, 17APR13 BU1, 15MAR13 BU1, 22SEP12 BU1, 22AUG12 BU1, 23AUG12 BU1, 29JUN12 BU1, 24MAY12 BU1, 25APR12 BU1, and 02MAR12 BU1 Class I Gluten Free Cafe Cinnamon Sesame Bar is recalled due to the potential to be contaminated with Salmonella. The recalled Roasted peanuts from Sunland Inc., were used as ingredients in this product. BumbleBar, Inc.
Food Gluten Free Cafe Chocolate Sesame Bar. The Retail Carton has a UPC 70795-03450 and the Individual Bar has a UPC 70795-03550. The product is labeled in parts: "***Chocolate Sesame Bars With Flax Seeds & Roasted Peanuts***gluten free cafe***NET WT .95 OZ (27g); myglutenfreecafe.com; glutenfreechoices.com Best By dates: 01MAY13 BU1, 30APR13 BU1, 18MAR13 BU1, 20OCT12 BU1, 19OCT12 BU1, 17OCT12 BU1, 16OCT12 BU1, 04JUL12 BU1, 03JUL12 BU1, 26APR12 BU1, and 21MAR12 BU1. Class I Gluten Free Cafe Chocolate Sesame Bar is recalled due to the potential to be contaminated with Salmonella. The recalled Roasted peanuts from Sunland Inc., were used as ingredients in this product. BumbleBar, Inc.
Devices 100/120V AC, Advanced Perfusion System Platform (APS) The Terumo® Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. Catalog number: 801763 and all serial numbers Class II Terumo Cardiovascular System (TCVS) has received reports of a situation where users experienced a total loss of functionality for some System 1 units. The reports indicate that the units went blank and shut down with no sign of power and battery backup did not initiate. The result is all pumps stop, with no safety system functionality, and the battery would not be activated. The user would be limited in the ability to provide adequate cardiopulmonary support. The potential injury is high should this apparently rare event occur and the event with recovery steps is not described in the operator manual. Terumo Cardiovascular Systems Corporation
Devices 220/240V AC, Advanced Perfusion System Platform (APS) The Terumo® Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. Catalog number: 801764 and all serial numbers Class II Terumo Cardiovascular System (TCVS) has received reports of a situation where users experienced a total loss of functionality for some System 1 units. The reports indicate that the units went blank and shut down with no sign of power and battery backup did not initiate. The result is all pumps stop, with no safety system functionality, and the battery would not be activated. The user would be limited in the ability to provide adequate cardiopulmonary support. The potential injury is high should this apparently rare event occur and the event with recovery steps is not described in the operator manual. Terumo Cardiovascular Systems Corporation
Devices NexGen CompleteKnee Solution Stemmed Nonaugmentable Tibial component The NexGen® system is a semiconstrained, nonlinked condylar knee prostheses. The device is indicated for patients with severe knee pain and disability due to rheumatoid arthritis; osteoarthritis; traumatic arthritis; polyarthritis; collagen disorders and/or avascular necrosis of the femoral condyle; post-traumatic loss of joint configuration (particularly when there is patellofemoral erosion, dysfunction or prior patellectomy); moderate valgus, varus or flexion deformities; salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. Catalog 00-5986-047-02, lots 62049114 and 62045235. Class II Zimmer is initiating a lot specific recall of the NexGen® Stemmed Nonaugmentable Tibial Component due to the devices being processed through a manufacturing cleaning operation that was operating outside of the validated parameters. As a result, the devices may contain residual particulate from the manufacturing process. Risks include: Allergic reaction due to the foreign material or late onset allergic reaction and accelerated polyethylene wear caused by third body particles. Zimmer, Inc.
Devices Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier The intended use of these devices is to protect both patient and healthcare worker from transfer of microorganisms, body fluids and particulate matter. Part Number Lot Number 4511 201008270110 Class II The firm initiated the recall due to a labeling error. The boxes labeled as Pinnacle Cure Sleeve 4511, which fits 11mm light guides, actually contain Pinnacle Cure Sleeves that fit 7mm or 8mm light guides (part number 4500). Metrex Research, LLC.
Food Bolthouse Farms Carrot Chips (Croustilles Aux Carottes). No Preservatives. Product of the U.S.A. Net Wt. 16 oz (1 lb) 454 b poids net. UPC 71464 17209 Product was also packed under brand names of Safeway Farms, UPC 21130 70217 and Farm Stand (private label for SuperValue). Bolthouse Farms, Bakersfield, CA Bolthouse Farms Best if Used by NOV 12 2012 04 T xxxx BF212 J11 and Best If used by Nov 13, 2012 04T XXXX BF212 J12. Safeway Farms Best if Used by Nov 13, 2012 06 T xxx S2682 BF 212 J12 286. Farm Stand Best If Used by Nov 12-12-2012, 04 t xxxx BF 212 J11-12. Class I Random sampling conducted by the North Carolina Department of Agriculture and Consumer Protective Services had a positive result for Salmonella in Bolthouse Carrot Chips. Wm Bolthouse Farms Inc
Food Murray's WAFFLE CONE DIP, NET WEIGHT - 7 lb 8 oz (3.40 kg), Product Item Code 835462, Bar code 0 06847 66003 2. The product is packaged in # 10 cans, 3 cans per case. Lot # 1217800201; Expiration date 06/17/2014 Class I The product contains undeclared allergens milk and soybean oil due to mislabeling. CSM Bakery Products NA
Drugs Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT --- NDC 0597-0149-54 Lot 201900 Expiration Date: JAN 2015 Class II Defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product Boehringer Ingelheim Roxane Inc
Devices Kimberly-Clark Patient Warming System - Model 1000 Control Unit The product is a thermal regulating system, indicated for monitoring and controlling patient temperature. Serial Number - SA09043017, SA09043019, SA0904320, SA09043018, SA09043015, SA09043012, SA09043016, SA09043014, SA09043013, SA09043009, SA09043011, SA09043010, SA09043008, SA09043007, SA09043006, SA09043003, SA09043005, SA09043004, SA09043002, SA09043001, SA09020013, SA09020012, SA09020014, SA09020011, SA09020010, SA09020009, SA0902008, SA09020006, SA09020007, SA08343100, SA09020004, SA09020005, SA09020002, SA09020003, SA09020001, SA08343099, SA08343098, SA08343097, SA08343096, SA08343095, SA08343094, SA08343093, SA08343092, SA08343091, SA08343090, SA08343089, SA08343087, SA08343088, SA08343086, SA08343085, SA08343083, SA08343084, SA08343053, SA08343073, SA08288014, SA08288002, SA08343054, SA08343082, SA08343081, SA08343080, SA08343079, SA08343078, SA08343077, SA08165007, SA08343076, SA08343075, SA08343074, SA08343072, SA08343055, SA08288007, SA08343071, SA08343070, SA08343069, SA08343068, SA08343067, SA08343066, SA08343065, SA08343064, SA08343063, SA08343059, SA08343058, SA08343062, SA08343061, SA08343060, SA08343056, SA08343057, SA08288012, SA08288017, SA08288016, SA08288015, SA08288013, SA08288011, SA08288009, SA08288006, SA08288003, SA08288010, SA08288008, SA08288004, SA08288005, SA08288001, SA08165013, SA08165014, SA08165015, SA08165018, SA08165016, SA08165017, SA08165006, SA08165005, SA08165011, SA08165012, SA08165010, SA08165009, SA08165004, SA08165008, SA08165002, SA08165003, SA08144035, SA08144030, SA08165001, SA08144034, SA08144033, SA08144032, SA08144031, SA08144029, SA08144028, SA08144025, SA08144027, SA08144021, SA08144026, SA08144024, SA08144023, SA08144022, SA08136010, SA08136006, SA08136003, SA08136009, SA08136005, SA08136004, SA08136007, SA08136001, SA08136002, SA08136008, SA08094129, SA08094137, SA08094141, SA08094136, SA08094150, SA08094153, SA08094152, SA08094151, SA08094149, SA08094145, SA08094148, SA08094147, SA08094143, SA08094146, SA08094142, SA08094144, SA08094140, SA08094139, SA08094138, SA08094134, SA08094130, SA08094132, SA08094135, SA08094131, SA08094133, SA08094127, SA08094128, SA08094125, SA08094126, SA08094124, SA08017044, SA08017049, SA08017045, SA08017040, SA08017034, SA08017035, SA08017041, SA08017047, SA08017042, SA08017043, SA08017048, SA08017039, SA08017046, SA08017038, SA08017037, SA08017030, SA08017036, SA08017028, SA08017029, SA08017027, SA08017033, SA08017031, SA08017032, SA07344022, SA07344029, SA07344028, SA07344026, SA07344027, SA07344030, SA07344021, SA07344023, SA07344024, SA07344025, SA07320002, SA07320001, SA07320014, SA07320015, SA07320013, SA07320011, SA07320012, SA07320006, SA07320005, SA07320008, SA07320010, SA07320009, SA07320007, SA07320004, SA07320003, SA07261006, SA07257008, SA07261004, SA07261007, SA07261002, SA07257004, SA07257007, SA07257003, SA07257002, SA07261005, SA07261008, SA07261003, SA07261001, SA07257005, SA07257006, SA07257001, SA07250005, SA07250004, SA07250002, SA07250003, SA07250001, SA07228007, SA07228008, SA07228001, SA07228002, SA07228003, SA07228004, SA07228005, SA07228006, SA07180006, SA07180005, SA07180004, SA07180003, SA07180002, SA07180001, SC07171006, SC07171005, SC07171004, SC07171003, SC07171002, SC07171001 Class II Error 85 alarm on the Model 1000 Control Unit was occasionally triggered inappropriately. Kimberly-Clark Corporation
Drugs Vicks NyQuil Cold & Flu, Nighttime Relief, 12 FL OZ bottle, Dist. by Proctor and Gamble, Cincinnati, OH 45040. NDC 37000-808-12 Lot #2278171941, Exp. 09/14, Lot #2282171981, Exp. 09/14 . Class II Labeling Illegible: Portions of the product labeling in the area of the dosing directions, the warnings & other information sections is obscured. Procter & Gamble Co
Food Jimmy Dean French Toast & Sausage Sandwich, Net Wt 3.9 oz (110g); a food service individually butcher paper wrapped, fully cooked frozen sandwich; 12 sandwiches per 2.74 lb case; UPC 54500 51434 Incorrect back label: UPC 54500 51434, item 51434, code date 12292P1; Case SKU 51366 Class I Some of the Jimmy Dean French Toast & Sausage Sandwiches were mislabeled on the back label with an ingredients statement for another product, resulting in undeclared allergens, egg and soy, not listed on the label. Hillshire Brands Company
Food Nesquik Chocolate Powder, 1) 6x40.7oz, UPC 0 28000 68230 9. 2) 12x21.8oz, UPC 0 28000 68090 9. 3) 12x10.9oz, UPC 0 28000 67990 3. Production codes: 1) 2282574810 and 2282574820. 2)2278574810, 2278574820, 2279574810, 2279574820, 2284574820, 2284574830, 2285574810, 2285574820, 2287574820, 2289574810, 2289574820. 3) 2278574810. Class I Nestle is recalling Nesquik Chocolate Powder because certain lots of its ingredients, calcium carbonate, may be contaminated with Salmonella. Nestle USA
Food Kroger Deluxe French Vanilla Magnifique Ice Cream, 48 FL OZ laminated carton. INGREDIENTS: MILK, CREAM, SUGAR***CONTAINS: MILK, EGGS DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202***800-632-6900 or www.kroger.com. UPC 11110 50718; Sell By: Jun 12, 2013 49-70 Class I The firm was notified that the ice cream may contain Pecans and, if eaten, could result in severe allergic reaction in persons sensitive to Pecans Kroger Co
Devices The brand name is MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set, Lot Code LBG001. The generic name is infusion administration set. Labeling indicates ~10 ml, Latex-free Infusion Set with Needle-free Port, One injection Port. Device is single use only, do not resterilize, and is available only by prescription. Device made in U.S.A. by Iradimed Corporation located in Winter Park, FL 32792. Lot LBG001, Exp 07/2016 The MRidium MRI Infusion Pumps and Infusion Sets are intended for general hospital or clinical use by medical professionals whenever it is required to infuse patients with intra-venous or intra-arterial fluids before, during, or after Magnetic Resonance Imaging (MRI) scans. The device is available for sale only upon the order or a physician or other related licensed medical professional, and not intended for any home use applications. The device Lot Code is LBG001. The "L" indicates facility, Las Piedras Facility. The "B" indicates year manufactured, 2012. The "G" indicates month manufactured, July. The "001" indicates the sequential lot build, restarts at 1 every month. Class II Iradimed Corporation is recalling MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set, Lot Code LBG001 because a section of the device does not meet specifications. Iradimed Corporation
Devices Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle Ref: UMH700 The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning of the uterus, fallopian tubes and ovaries is desirable. These types of surgeries include laparoscopic tubal ligation, and/or operative laparoscopy All serial numbers Class II Excessive pressure exerted on the uterine tip when attached to the Arch may, under certain circumstances, cause the internal steel rod of the tip to protrude through the cleaning hole on the shaft of the handle Cooper Surgical, Inc.
Devices Cooper Surgical Advincula Arch , Reusable Uterine Manipulator Handle Ref: UMH750 The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning of the uterus, fallopian tubes and ovaries is desirable. These types of surgeries include laparoscopic tubal ligation, and/or operative laparoscopy Arch handles with a serial number less than 1204001, or between 1111001 0 and 1111 0069 Class II Excessive pressure exerted on the uterine tip when attached to the Arch may, under certain circumstances, cause the internal steel rod of the tip to protrude through the cleaning hole on the shaft of the handle Cooper Surgical, Inc.
Drugs Arranon (nelarabine) Injection 5mg/mL, 50mL Vials, Rx only, For I.V. Infusion only, GlaxoSmith Kline, Research Triangle Park, NC 27709. Made in England, NDC 0007-4401-06 Lot # C536707 Exp 02/14, C538830 Exp.02/14, C533169 Exp. 02/14 Class II Impurities/Degradation Products: Potential for drug related impurities to exceed the specification limits. GlaxoSmithKline, LLC.
Food Chicken of the Sea Solid White Tuna in Water, 7 oz., 48 cans per case (case: 6 sets of multi-unit packs of 8 cans each), UPC 4800000097, case UPC 4800076127. Best By Date Can Code October 1 2016 BE11D ASWAP October 1 2016 BE11D ASWAP October 1 2016 BE14D ASWAP October 1 2016 BE14D ASWAP October 1 2016 BE15D ASWAP October 1 2016 BE15D ASWAP October 1 2016 BE1AD ASWAP October 1 2016 BE1BD ASWAP October 1 2016 BE1CD ASWAP October 1 2016 BE1CD ASWAP October 1 2016 BE1CD ASWAP October 1 2016 BE1DD ASWAP October 1 2016 BE1DD ASWAP October 1 2016 BE1ED ASWAP October 1 2016 BE1AD ASWAP October 1 2016 BE1ED ASWAP October 1 2016 BE1BD ASWAP October 1 2016 BE1CD ASWAP October 1 2016 BE1ED ASWAP October 1 2016 BE15D ASWAP October 1 2016 BE1BD ASWAP October 1 2016 BE1CD ASWAP October 1 2016 BE1DD ASWAP October 1 2016 BE1ED ASWAP October 10 2016 BEA1D ASWAP October 10 2016 BEA1D ASWAP October 10 2016 BEAED ASWAP October 11 2016 BEBAD ASWAP October 11 2016 BEB1D ASWAP October 11 2016 BEBDD ASWAP October 11 2016 BEB1D ASWAP October 11 2016 BEB2D ASWAP October 11 2016 BEB3D ASWAP October 11 2016 BEB3D ASWAP October 11 2016 BEB3D ASWAP October 11 2016 BEB3D ASWAP October 11 2016 BEB4D ASWAP October 11 2016 BEB5D ASWAP October 11 2016 BEB5D ASWAP October 11 2016 BEBAD ASWAP October 11 2016 BEBAD ASWAP October 11 2016 BEBAD ASWAP October 11 2016 BEBAD ASWAP October 11 2016 BEBBD ASWAP October 11 2016 BEBBD ASWAP October 11 2016 BEBCD ASWAP October 11 2016 BEBCD ASWAP October 11 2016 BEBDD ASWAP October 11 2016 BEBDD ASWAP October 11 2016 BEBDD ASWAP October 11 2016 BEBED ASWAP October 11 2016 BEBED ASWAP October 11 2016 BEBED ASWAP October 12 2016 BECCD ASWAP October 12 2016 BEC4D ASWAP October 12 2016 BECAD ASWAP October 12 2016 BECBD ASWAP October 12 2016 BECCD ASWAP October 12 2016 BEC1D ASWAP October 12 2016 BEC5D ASWAP October 12 2016 BECBD ASWAP October 12 2016 BECCD ASWAP October 2 2016 BE21D ASWAP October 2 2016 BE21D ASWAP October 2 2016 BE22D ASWAP October 2 2016 BE22D ASWAP October 2 2016 BE23D ASWAP October 2 2016 BE23D ASWAP October 2 2016 BE24D ASWAP October 2 2016 BE24D ASWAP October 2 2016 BE25D ASWAP October 2 2016 BE25D ASWAP October 2 2016 BE2BD ASWAP October 2 2016 BE2CD ASWAP October 2 2016 BE2DD ASWAP October 2 2016 BE21D ASWAP October 2 2016 BE25D ASWAP October 2 2016 BE2AD ASWAP October 2 2016 BE2DD ASWAP October 2 2016 BE22D ASWAP October 2 2016 BE22D ASWAP October 2 2016 BE2BD ASWAP October 2 2016 BE22D ASWAP October 2 2016 BE25D ASWAP October 2 2016 BE2AD ASWAP October 2 2016 BE2BD ASWAP October 2 2016 BE2BD ASWAP October 2 2016 BE2CD ASWAP October 2 2016 BE2CD ASWAP October 2 2016 BE2DD ASWAP October 2 2016 BE2DD ASWAP October 2 2016 BE2ED ASWAP October 2 2016 BE21D ASWAP October 2 2016 BE2AD ASWAP October 2 2016 BE2BD ASWAP October 2 2016 BE2BD ASWAP October 2 2016 BE2BD ASWAP October 2 2016 BE2CD ASWAP October 2 2016 BE2DD ASWAP October 2 2016 BE2ED ASWAP October 3 2016 BE31D ASWAP October 3 2016 BE31D ASWAP October 3 2016 BE31D ASWAP October 3 2016 BE31D ASWAP October 3 2016 BE31D ASWAP October 9 2016 BE93D ASWAP October 9 2016 BE93D ASWAP October 9 2016 BE95D ASWAP October 9 2016 BE9AD ASWAP October 9 2016 BE9AD ASWAP October 9 2016 BE9BD ASWAP October 9 2016 BE9BD ASWAP October 9 2016 BE91D ASWAP October 9 2016 BE92D ASWAP October 9 2016 BE93D ASWAP October 9 2016 BE93D ASWAP October 9 2016 BE94D ASWAP October 9 2016 BE94D ASWAP October 9 2016 BE95D ASWAP Class I Chicken of the Sea is recalling Solid White Tuna in Water because the product label has undeclared soy allergen. Tri-Union Seafoods, L.L.C dba Chicken of the Sea.
Drugs Advair HFA (fluticasone propionate 45 mcg and salmeterol 21 mcg) Inhalation Aerosol, 12g, 120 Metered Actuations, For Oral Inhalation with Advair HFA actuator only, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0715-20. Lot #: 1ZP2465, Exp Oct-12, 1ZP5224, Exp. Nov-12, 1ZP5455, 1ZP6916, Exp. Dec-12, 1ZP8042, 1ZP9593, Exp Jan-13, 1ZP9900, Exp. Mar-13, 1ZP1134, Exp. Apr-13, 1ZP3190, 2ZP6531, Exp. May-13, 2ZP6924, 2ZP7258, Exp. Jul-13, 2ZP1886, 2ZP9975, 2ZP0027, 2ZP9782, Exp. Sep-13, 2ZP1331, Exp. Oct-13, 2ZP2366, Exp. Nov-13. Class III Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification. GlaxoSmithKline, LLC.
Drugs Advair HFA (fluticasone propionate/salmeterol) Inhalation Aerosol, 45mcg/21 mcg 60 Actuations INST, NDC 0173-0715-22, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709. 1ZP3065, Exp. Oct-12, 1ZP5453, Exp. Dec-12, 1ZP3315, Exp. May-13, 2ZP9974, Exp. Sep-13. Class III Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification. GlaxoSmithKline, LLC.
Devices Echo Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless Porous Stem (Orthopedic Implant) Indications: 1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2) rheumatoid arthritis, 3) correction offunctional deformity, 4) treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques, 5) revision of previously failed total arthoplasty. Catalog Number: 192411 and Lot Number Identification: 244800 Class II It was reported that the surgeon noticed that the Echo 11mm hip stem had an etching indicating it was 13mm stem. Biomet, Inc.
Food Ground Hot Pepper Chillies, 5 oz. plastic jars, 24 jars/case; jars labeled in part ***Imported and distributed by Nina International Inc., P.O. Box 2176, Hyattsville, MD 20784***Product of Ghana*** UPC 745851004004 Class I Food may be contaminated with Salmonella. Ernimich, Inc. (dba Nina International, Inc.)
Devices The Vertex Max Drill Tube is a component within the Navigated Vertex Max Drill Guide Set (item 9733370). The Navigated Vertex Max Drill Guide Set is intended to be used with a Medtronic Computer Assisted Surgery System to help assist with screw placement during spine surgical procedures. The device is reusable and requires sterilization according to product labeling. . Lot number 120203. Class II Medtronic is recalling certain Vertex Max Drill Tubes which are used with the StealthStation System due to a defect related to the internal threading for component set up. Medtronic Navigation, Inc.
Food Almondine Wedding Cookies sold by the pound. Purchased between 10/22/2012 and 11/15/2012 Class I Product contains undeclared allergen: almonds . Whole Foods Market South Seafood Distribution
Food Wedding Cookies (Baked Fresh In-Store), Whole Foods Market, sold by the pound. Purchased between 10/22/2012 and 11/15/2012 Class I Product contains undeclared allergens: pecans. Whole Foods Market South Seafood Distribution
Food United Dairy Farms brand Oatmeal Cookie Overload Ice Cream 3 gallon, corrugated square B23111 B23712 Class I Product may contain salmonella United Dairy Farmers Inc
Drugs Atorvastatin Calcium Tablets, 10 mg, 90 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257, USA, by: Ranbaxy Laboratories Ltd., New Delhi - 110019, India, NDC #: 63304-827-90 Lot #s: 2436144, 2436582, 2441567, 2441568, Exp 08/31/2014. Class II Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates. Ranbaxy Inc.
Drugs Atorvastatin Calcium Tablets, 20 mg, 90 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257, USA, by: Ranbaxy Laboratories Ltd., New Delhi - 110019, India, NDC #: 63304-828-90 Lot #s: 2436731, 2437381, 2437940, 2437942, 2437945, 2437947, 2437952, 2437953, 2437960, 2440676, 2440677, 2440680, 2440681, Exp 08/31/2014. Class II Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates. Ranbaxy Inc.
Drugs Atorvastatin Calcium Tablets, 40 mg, a) 90 tablets per bottle, b) 500 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257, USA, by: Ranbaxy Laboratories Ltd., New Delhi - 110019, India, NDC #: a) 63304-829-90, b) 63304-829-05. a) 40 mg 90 count, Lot #s: 2434265, 2434266, 2434824, 2434826, 2434827, 2434828, 2434829, 2434830, 2434831, Exp 07/31/2014; 2436580, 2436725, 2436727, 2436729, 2437377, 2437380, 2437941, 2437943, 2437944, 2437949, 2437950, 2437955, Exp 08/31/2014. b) 40 mg 500 count, Lot #s: 2437956, 2437957, 2440675, Exp 08/31/2014. Class II Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates. Ranbaxy Inc.
-
-