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U.S. Department of Health and Human Services

Enforcement Report - Week of October 3, 2012

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Source Plasma 7020569758;7020569243;7020561213;7020560515;7020559510;7020558871;7020557589;7020556923;7020555960;7020554644;7020554249;7020551927;7020549396;7020548750;7020546254;7020545607;7020543963;7020542709;7020541769;7020541080;7020540134;7020537340;7020536579;7020535741;7020534950;7020533777;7020532633;7020531792;7020530859;7020530108;7020528828;7020528109;7020527346;7020526610;7020525530;7020525122;7020522123;7020521031;7020518895;7020518020;7020516872;7020516410;7020514961;7020514002;7020505987;7020504543;7020501835;7020501348;7020500269;7020499825;7020496782;7020496011;7020495192 Class II Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed. ZLB Bioplasma, Inc.
Biologics Red Blood Cells Leukocytes Reduced 6554173 Class II Blood products, which were collected from a donor with a history of multiple high risk behaviors, were distributed. Community Blood Bank of Lancaster County Medical Society
Biologics Blood and Blood Products for Reprocessing 6554173 Class II Blood products, which were collected from a donor with a history of multiple high risk behaviors, were distributed. Community Blood Bank of Lancaster County Medical Society
Biologics Fresh Frozen Plasma W045007045551;W045007050899 Class III Blood product, for which viral marker testing was incomplete, were distributed. Community Blood Center of Greater Kansas City
Biologics Red Blood Cells Leukocytes Reduced W045007701266;W045007048992;W045007033136;W045007045551;W045007050899;W045007037595 Class III Blood product, for which viral marker testing was incomplete, were distributed. Community Blood Center of Greater Kansas City
Biologics Platelets Pheresis Leukocytes Reduced Irradiated 3695222(Part A); 3695222(Part B) Class II Blood products, collected using expired control materials, were distributed. Community Blood Bank of Lancaster County Medical Society
Biologics Platelets Pheresis Leukocytes Reduced 3695245; 3695218(Part A), 3695218 (Part B) 3695248 (Part A), 3695248 (Part B); Class II Blood products, collected using expired control materials, were distributed. Community Blood Bank of Lancaster County Medical Society
Biologics Blood and Blood Products for Reprocessing 4718843 Class II Blood products, collected from a donor who received a tatoo within 12 months of donation, were distributed. Mary Greeley Medical Center
Biologics Red Blood Cells 4718843 Class II Blood products, collected from a donor who received a tatoo within 12 months of donation, were distributed. Mary Greeley Medical Center
Biologics Red Blood Cells Leukocytes Reduced W045005138494 Class III Blood product, manufactured without additive solution, was distributed. Community Blood Center of Greater Kansas City
Biologics Red Blood Cells S9911446 Class II Blood product, which tested negative for hepatitis, but was collected from a donor who previously tested positive for the antibody to hepatitis B core antigen (anti-HBcore) on two separate occasions, was distributed. Mercy Medical Center Blood Bank
Biologics Red Blood Cells Leukocytes Reduced W045006019703 Class II Blood product which did not meet Quality Control specifications was distributed. Community Blood Center of Greater Kansas City
Biologics Red Blood Cells Leukocytes Reduced Washed W045006059851 Class III Blood product, with an unacceptable low red cell recovery rate, was distributed. Community Blood Center Of Gtr KC
Biologics Platelets Pheresis Leukocytes Reduced W045006909473 Class III Blood product, which was exposed to unacceptable temperature during storage, was distributed. Community Blood Center Of Gtr KC
Biologics Platelets Pheresis Leukocytes Reduced 006KK04845, 006KK04846, 006KK04847(Part A), 006KK04847(Part B), 006KR45572 Class III Blood products, for which no documentation of shipment or storage at appropriate temperatures were distributed. American National Red Cross (The)
Biologics Fresh Frozen Plasma 09Q 85020 Class II Blood products, collected from a donor who was previously deferred, were distributed American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 09FZ59427; 09GX45894; 09GX47142; 09Q 85020 Class II Blood products, collected from a donor who was previously deferred, were distributed American National Red Cross (The)
Biologics Blood and Blood Products for Reprocessing 09FZ53427; 09GX45894; 09GX47142 Class II Blood products, collected from a donor who was previously deferred, were distributed American National Red Cross (The)
Biologics Platelets Pheresis Leukocytes Reduced K46171;K46171;K46171 Class III Blood products, which did not meet the acceptable product specifications for release, were distributed. Mississippi Valley Reg Bld Ctr
Biologics Platelets Pheresis Leukocytes Reduced W045007905565 Class III In this situation, blood product was stored where the temperature was not continuously monitored, was distributed. Community Blood Center Of Gtr KC
Biologics Red Blood Cells Leukocytes Reduced 8011980 Class III Blood products, which Viral Testing performed, interpreted, or documented incorrectly, were distributed. Community Blood Bank of Lancaster County Medical Society
Biologics Platelets Pheresis Leukocytes Reduced 3754793;3754792 Class III Blood products, which Viral Testing performed, interpreted, or documented incorrectly, were distributed. Community Blood Bank of Lancaster County Medical Society
Biologics Blood and Blood Products for Reprocessing 6067919;6070284;6075510 Class III Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. Community Blood Bank of Lancaster County Medical Society
Biologics Red Blood Cells Leukocytes Reduced 6066046;6070284;6073935;6075510 Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. Community Blood Bank of Lancaster County Medical Society
Biologics Cryoprecipitated AHF 6066046 Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. Community Blood Bank of Lancaster County Medical Society
Biologics Plasma Cryoprecipitated Reduced 6066046 Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. Community Blood Bank of Lancaster County Medical Society
Biologics Fresh Frozen Plasma 6073935 Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. Community Blood Bank of Lancaster County Medical Society
Biologics Blood and Blood Products for Reprocessing 09GH73273 Class III Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 09GH73273 Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 09Q98860; 09Q98888; 09Q98889 Class III Blood products, for which storage conditions and shipment information were undocumented, were distributed. American Red Cross Blood Services
Biologics Blood and Blood Products for Reprocessing 3750331 Class III Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. Community Blood Bank of Lancaster County Medical Society
Biologics Red Blood Cells Leukocytes Reduced 3750331 Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. Community Blood Bank of Lancaster County Medical Society
Biologics Red Blood Cells Leukocytes Reduced W038308071454;W038308071457 Class II Blood products, which component preparation were not prepared in accordance with specifications, were distributed. Mississippi Valley Regional Blood Center
Biologics Red Blood Cells Leukocytes Reduced 004KK58808 Class II Blood products, collected from a donor in whom donor suitability were not adequately determined, were distributed. American National Red Cross (The)
Biologics Blood and Blood Products for Reprocessing 004KK58808 Class II Blood products, collected from a donor in whom donor suitability were not adequately determined, were distributed. American National Red Cross (The)
Biologics Micro SSPTM Allele Specific HLA Class I DNA Typing Tray - B*35 510(K) Number 8K 960062 Product number SSPR1-35 Product Insert Number SSP_DNAT_PIEN Rev 16 Product Name: Micro SSPTM Allele Specific HLA Class I DNA Typing Tray - B*35 Product Number: SSPR1-35 Lot Number: 002, batch 004 Expiration Date: 10/2013 Product Insert Number: SSP- DNAT-P-I EN Rev 16 510(K) Number BK 960062 Product Code MZI Class II HLA typing assay, associated with false negative results, was distributed. One Lambda Inc
Biologics Micro SSP Allele Specific HLA Class I DNA Typing Tray-AB, Product Number: SSP1-AB, Lot 003, batch 007 Micro SSP Allele Specific HLA Class I DNA Typing Tray-AB, Product Number: SSP1-AB, Lot Number 003, batch 007 Expiration August 2013. Product insert Number SSP_DNAT_PI-EN Rev 16; 510(K) Number BK960062; Product Code MZI Class II HLA typing assay, associated with false negative results, was distributed. One Lambda Inc
Biologics Source Plasma 49400010468, 49400015066, 49400019112, 49400024691, 49400029193,49400038129, 49400040982, 49400074365, 49400079780, 49400020981, 49400028123, 49400031613, 49400051710, 49400071850, 49400072693, 49400074701, 49400017328, 49400027892, 49400032720,49400037759, 49400054663, 49400074496, 49400078673, 49400008974, 49400018099, 49400020762, 49400029484, 49400036852,49400048618, 49400056204, 49400072001, 49400079502, 49400021036, 49400027340,49400031058, 49400037943, 49400029249, 49400035251,49400039922, 49400074648,49400079406, 49400049215, 49400049098, 49400025838,49400037003, 49400054911, 49400076694, 49400035470, 49400053636, 49400073725, 49400074947, 49400017627, 49400024907, 49400027737, 49400035390,49400038356, 49400053353, 49400050742,49400010812,49400015470,  ...
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Class II Blood products, collected from a donor, whose suitability to donate was not adequately determined, was distributed. CSL Plasma, Inc.
Biologics Source Plasma 4270034435, 4270033702, 4270032835, 4270032531, 4270031860, 4270031545, 4270030925, 4270030610, 4270029947, 4270029572, 4270029101, 4270028782, 4270028101, 4270027804, 4270027164, 4270026836, 4270026282, 4270025918, 4270025278, 4270024961 Class III Blood products, collected from a donor, for whom donor suitability was not adequately determined, were distributed. Octapharma Plasma, Inc.
Biologics Red Blood Cells Leukocytes Reduced W035811140656; W035811140648; W035811140646; W035811140704; W035811140619; W035811140556; WO35811140707; Class II Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed. BloodSource, Inc.
Biologics Red Blood Cells Leukocytes Reduced Irradiated W035811140557 Class II Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed. BloodSource, Inc.
Biologics Red Blood Cells Leukocytes Reduced W128711300920 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Delta Blood Bank
Biologics Blood and Blood Products for Reprocessing W128711102646 Class III Blood product, collected from a donor whose arm preparation was not documented, was distributed. Delta Blood Bank
Biologics Red Blood Cells Leukocytes Reduced W128711122482 Class II Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed. Delta Blood Bank
Food McClure's Pies & Salads, Inc. Walnut Cinnamon Streusel Cake All product distributed prior to 11/15/2011 Class I Undeclared allergens. Ingredient statement lists "nuts" but is not specific for walnuts. Label does say, "Walnut Cinnamon Streusel Cake." McClures, Inc.
Food McClure's Pies & Salads, Inc. Apple Cinnamon Streusel Cake All product distributed prior to 11/15/2011 Class I Undeclared allergens. Ingredient statement lists "nuts" but is not specific for walnuts. McClures, Inc.
Food McClure's Pies & Salads, Inc. Marble Cake All product distributed prior to 11/15/2011 Class II Undeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour. McClures, Inc.
Food McClure's Pies & Salads, Inc. German Chocolate Cake All product distributed prior to 11/15/2011 Class II Undeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour. McClures, Inc.
Food McClure's Pies & Salads, Inc. Chocolate Cake All product distributed prior to 11/15/2011 Class II Undeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour. McClures, Inc.
Food McClure's Pies & Salads, Inc. Red Velvet Cake All product distributed prior to 11/15/2011 Class II Undeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour. McClures, Inc.
Food McClure's Pies & Salads, Inc. Black Walnut Cake All product distributed prior to 11/15/2011 Class II Undeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour. McClures, Inc.
Food McClure's Pies & Salads, Inc. Yellow Cake All product distributed prior to 11/15/2011 Class II Undeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour. Also, coloring (yellow #5) is not listed. McClures, Inc.
Food McClure's Pies & Salads, Inc. Lemon Crunch Cake All product distributed prior to 11/15/2011 Class II Undeclared allergens. Ingredient statement lists "nuts" but is not specific for walnuts. Also, coloring is not listed - Yellow #5 McClures, Inc.
Food McClure's Pies & Salads, Inc. Lemon Glazed Cake All product distributed prior to 11/15/2011 Class II Undeclared allergens. Ingredient statement does not list coloring - Yellow #5. McClures, Inc.
Food McClure's Pies & Salads, Inc. Orange Cake All product distributed prior to 11/15/2011 Class II Undeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour McClures, Inc.
Food McClure's Pies & Salads, Inc. Apple Dumplings All product distributed prior to 11/15/2011 Class II Undeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour McClures, Inc.
Food McClure's Pies & Salads, Inc. French Apple Pie All product distributed prior to 11/15/2011 Class II Undeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour McClures, Inc.
Food McClure's Pies & Salads, Inc. Peach Pie All product distributed prior to 11/15/2011 Class II Undeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour McClures, Inc.
Food McClure's Pies & Salads, Inc. Blueberry Pie All product distributed prior to 11/15/2011 Class II Undeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour McClures, Inc.
Food McClure's Pies & Salads, Inc. Cherry Pie All product distributed prior to 11/15/2011 Class II Undeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour McClures, Inc.
Food McClure's Pies & Salads, Inc. Apple Pie All product distributed prior to 11/15/2011 Class II Undeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour McClures, Inc.
Food McClure's Pies & Salads, Inc. Pumpkin Pie All product distributed prior to 11/15/2011 Class II Undeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour McClures, Inc.
Food McClure's Pies & Salads, Inc. Banana Cream Pie All product distributed prior to 11/15/2011 Class II Undeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour McClures, Inc.
Food McClure's Pies & Salads, Inc. Cherry Custard Pie All product distributed prior to 11/15/2011 Class II Undeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour McClures, Inc.
Food McClure's Pies & Salads, Inc. Coconut Custard Pie All product distributed prior to 11/15/2011 Class II Undeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour McClures, Inc.
Food McClure's Pies & Salads, Inc. Egg Custard Pie All product distributed prior to 11/15/2011 Class II Undeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour McClures, Inc.
Food McClure's Pies & Salads, Inc. Chocolate Cream Pie All product distributed prior to 11/15/2011 Class II Undeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour McClures, Inc.
Food McClure's Pies & Salads, Inc. Coconut Cream Pie All product distributed prior to 11/15/2011 Class II Undeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour McClures, Inc.
Food McClure's Pies & Salads, Inc. Shoo Fly Pie All product distributed prior to 11/15/2011 Class II Undeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour McClures, Inc.
Food McClure's Pies & Salads, Inc. Chocolate Shoo Fly Pie All product distributed prior to 11/15/2011 Class II Undeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour McClures, Inc.
Food McClure's Pies & Salads, Inc. Pecan Pie All product distributed prior to 11/15/2011 Class II Undeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour McClures, Inc.
Food McClure's Pies & Salads, Inc. Cole Slaw All product distributed prior to 11/15/2011 Class I Undeclared allergens. Ingredient statement lists "mayonnaise" but sub-ingredients are not listed for the mayonnaise McClures, Inc.
Food McClure's Pies & Salads, Inc. Macaroni Salad All product distributed prior to 11/15/2011 Class I Undeclared allergens. Ingredient statement lists "macaroni" but sub-ingredients for macaroni are not listed McClures, Inc.
Food McClure's Pies & Salads, Inc. Broccoli & Cauliflower Salad All product distributed prior to 11/15/2011 Class I Undeclared allergens. Ingredient statement lists "mayonnaise" but sub-ingredients for mayonnaise are not listed. In addition, product label lists cheese but does not list sub-ingredients from the cheese label. McClures, Inc.
Food McClure's Pies & Salads, Inc. Chicken Salad All product distributed prior to 11/15/2011 Class I Undeclared allergens. Ingredient statement lists "mayonnaise" but sub-ingredients for mayonnaise are not listed McClures, Inc.
Food McClure's Pies & Salads, Inc. Egg Salad All product distributed prior to 11/15/2011 Class I Undeclared allergens. Ingredient statement lists "mayonnaise" but sub-ingredients for mayonnaise are not listed McClures, Inc.
Food McClure's Pies & Salads, Inc. Potato Salad All product distributed prior to 11/15/2011 Class I Undeclared allergens. Ingredient statement lists "salad dressing" but sub-ingredients for salad dressing are not listed McClures, Inc.
Drugs Hard Ten Days Capsule, 4500 mg, boxes of 6 packets, OTC, Developed by: American Federal International Living Creature Group and Tibet Gold Source Living Creature Engineering Limited Company, Unit 18, 55 Beijing Road Central, Lhasa, Tibet All lots. Class I Marketed Without an Approved ANDA/NDA: presence of sildenafil www.vitaminbestbuy.com
Drugs Man King Capsules, 2800 mg, boxes of 5 packets, OTC, Developed by: American Wanbao Pharmaceutical International Group and Hainan Wanbao Biological Engineering Co., Ltd., 27 Heping Road, Haikou, Henan Province, UPC 9 009900 0032328 All lots. Class I Marketed Without an Approved ANDA/NDA: presence of sildenafil. www.vitaminbestbuy.com
Drugs Japan Weight Loss Blue Capsules, 9 g (300 mg), 30 count box, Green algae lipotropic (fat dissolving) agent, OTC, Distributed by Vitaminbestbuy.com, Brewerton, NY All lots. Class I Marketed Without an Approved ANDA/NDA: presence of sibutramine www.vitaminbestbuy.com
Biologics Plasma Frozen 506028927; 506028592; Class II Blood products, collected from a donor who gave history which warranted deferral or follow up were distributed. Blood Centers of the Pacific - Irwin Center
Biologics Fresh Frozen Plasma 506083305; Class II Blood products, collected from a donor who gave history which warranted deferral or follow up were distributed. Blood Centers of the Pacific - Irwin Center
Biologics Red Blood Cells Leukocytes Reduced 506030332; 506028927; 506028592; 506077852; 506071807; 506055283; W117009320416Y; W117008302038T; 509238455; 506050613; 506099742; 506088134; 506083305; 504804927; 504804630; 504287307; 500790860; Class II Blood products, collected from a donor who gave history which warranted deferral or follow up were distributed. Blood Centers of the Pacific - Irwin Center
Biologics Red Blood Cells Leukocytes Reduced W038512101381; Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. Walter L. Shepeard Community Blood Center, Inc.
Devices Terumo Advanced Perfusion System 1 ASSEMBLY FLOW POD Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment. Catalog number: 802018 and serial numbers: 00032, 00042, 00056, 00147, 00623, 00700-00764, 00766-00820, and 00823-00847. Class II Terumo Cardiovascular Systems (CVS) received two reports of the false back flow alarms for the Terumo® Advanced Perfusion System 1 when there was no tubing in the flow sensor. Terumo CVS' investigation found that the voltage level on a circuit board was improperly set in a population of flow modules for Terumo System 1, the sensor operates correctly if the tubing is installed and it is highly unlikely that the failure would recur. The failure only occurs when there is no tubing installed in the flow sensor, therefore the only risk to the patient is if the false alarm somehow delays the surgical procedure. There are no known reports of patient injury as a result of this issue. Terumo Cardiovascular Systems Corporation
Devices Terumo Advanced Perfusion System 1 Flow Module indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment. Catalog number: 802018 and serial numbers: 00122, 00337, 00340, 00343-00389, 00391-00395, 00397-00410, 00437, 00438, and 00488. Class II Terumo Cardiovascular Systems (CVS) received one report of a flow module for the Terumo Advanced Perfusion System 1 not displaying blood flow information on the Central Control Monitor or the Centrifugal Control Unit. The tricolor LED on the flow module was not illuminated. Terumo CVS' investigation found that the malfunction was caused by an improper component on a circuit board used in a population of flow modules for Terumo System 1. Terumo Cardiovascular Systems Corporation
Drugs Fentanyl Transdermal System, 100 mcg/h, each transdermal system contains: 10 mg fentanyl and 0.4 mL alcohol USP, Rx only, supplied in single pouches (NDC 0591-3214-54 (pouch)), 5 pouches per carton (NDC 0591-3214-72 (Carton)), Manufactured by Watson laboratories Inc., Corona, CA, Distributed by: Watson, Pharma Inc. Lot number 455040A (carton) 455040 (pouch) Class II Subpotent; some patches may not contain fentanyl gel Watson Laboratories, Inc.
Devices This voluntary medical device correction is related to Alcon products that present a 23G nonvalved trocar cannula and infusion cannula together. These items are available as components within Accurus 23G TotalPLUS Pak, Accurus 23G Combined Procedure Packs (0.9mm and 1.1mm), Constellation 23G Total PLUS Pak, Constellation 23G Combined Pack (0.9 mm and 1.1 mm) and 23G Small Parts Kit. Single use 23G non-valved trocar cannulas are used to provide internal access to the ocular cavity during ophthalmic surgery. Single use infusion cannulas are used for the infusion of fluid or air during ophthalmic surgery to maintain intraocular pressure during posterior segment surgeries. 1) 23G TotalPLUS Pak: Accurus Standalone - 8065750828, 2) 23G Combined Pack 0.9mm: Accurus Standalone - 8065750814, 3) 23G Combined Pack 1.1mm: Accurus Standalone - 8065750816, 4)23G TotalPLUS Pak: Constellation Standalone - 8065751058, 5) 23G Combined Pack 0.9mm: Constellation Standalone -8065751077, 6) 23G Combined Pack 1.1mm: Constellation Standalone - 8065751065.  ...
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Class II This medical device correction is related to Alcon products that present a 23G non-valved trocar cannula and infusion cannula together because of an issue regarding the loose fit between the 23G non-valved trocar cannula and infusion cannula that could potentially cause a detachment between the non-valved trocar cannula and infusion cannula during surgery. Alcon Research, LTD.
Drugs Vecuronium Bromide for Injection, For IV use only, 20 mg per vial, 10 x 10 mg Vials, lyophilized powder per carton, Rx Only, Mfr. By: Ben Venue Laboratories, Bedford, OH 44146: Mfg for: Bedford Labs, Bedford, OH 44146, NDC 55390-039-10. Lot #2067134 Exp 5/31/2013, NDC 55390-039-10 Class I Presence of Particulate Matter Ben Venue Laboratories Inc
Devices Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. For in vitro diagnostic use. Intended for the detection and quantitative determination of IgG antibody to VZV in human sera. Kit lot codes: 2325600-566, 2325601-566, 2325600-567, 2325601-567, 2325600-568 Class III The Positive Control for the Captia Varicella-Zoster Virus (VZV) IgG Kit has been reported as running high out of its assigned ISR range. Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Food Bulk Foods, Inc. Yellow Corn Meal, Light Roast, 25 lb; Bulk Foods, Inc. Yellow Corn Meal, Light Roast, 50 lb No codes; all product "Purchase by date shown 12/29/2012" Class II FDA samples of product tested positive for Fumonisin Haldeman Mills
Food Bulk Foods, Inc. Yellow Corn Meal, Regular Roast, 25 lb; Bulk Foods, Inc. Yellow Corn Meal, Regular Roast, 50 lb No codes; all product "Purchase by date shown 12/29/2012" Class II FDA samples of product tested positive for Fumonisin Haldeman Mills
Food Brinser's Best Yellow Corn Meal, 5 lb; Stauffer's Corn Meal, 2 lb No codes; all product "Purchase by date shown 12/29/2012" Class II FDA samples of product tested positive for Fumonisin Haldeman Mills
Devices BP7561 OPTI CCA-TS B-Lac Cassette (25 per box) Cassettes are consumables used in the OPTI CCA-TS Analyzer intended to be used for in vitro measurements of pH, PCOX2 PO2, lactate (lactic acid), total hemoglobin (tHb), and oxygen saturation (SO2), in heparinized whole blood samples (either arterial or venous) on the OPTI CCA-TS system, in either a clinical setting or point of care locations. Cassettes contain one-time use sensors that are used with the OPTI CCA-TS analyzer to perform in-vitro measurements of blood gases and metabolites. OPTI CCA-TS B-Lac Cassettes are supplied in boxes of 25 and may only used with the OPTI CCA-TS Analyzer. Lot numbers: 110650, 114650, 114651, 114652, 114653, 116650, 116652, 117650, 118651, 121650, 121651, 122652, 122652, 122653, 122654, 122655, 122656, 122657, 123654, 123655, 124650, 133650, 134651, 136650, 146650, 149650, 202650, 208650, 208651, 209560, 209651, 211650, 212651, 213650, 214650, 215650, 215651, 221650, 222650 and 224650. Class II The values reported for PCO2 by BP7561 B-Lac cassettes are biased at high concentrations when used at altitudes above 2800 feet (853 meters). OPTI Medical Systems, Inc
Drugs Synthroid (levothyroxine sodium) Tablets USP, 50 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-4552-90. 18265A8, Exp 09/20/2013 Class II Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets. Abbott Laboratories
Drugs Synthroid (levothyroxine sodium) Tablets USP, 75 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-5182-90. Lot: 18353A8, Exp 08/31/2013 Class II Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets. Abbott Laboratories
Drugs Synthroid (levothyroxine sodium) Tablets USP, 112 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-9296-90 Lot: 18355A8, Exp. 09/26/13 Class II Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets. Abbott Laboratories
Drugs Thallous Chloride Tl 201 Injection, Diagnostic Sterile, Non-Pyrogenic Solution, a) 2.8 mL (NDC 0019N12028) b) 6.3ml (NDC 0019N12063) For Intravenous Administration, each milliliter contains 37 MBq (1 mCi) Thallous Chloride Tl 201 (no carrier added) at date and time of calibration, 9 mg sodium chloride and 0.9% (v/v) benzyl alcohol as a preservative, RX, Mallinckrodt Inc., St. Louis, MO 63134 Lot 120-2686, exp. 8/2/12. Class III Labeling: Correct Labeled Product Miscart/Mispack: labels on outer containers do not match labels on vials (the correct label) Mallinckrodt Inc
Food "Derby City Vending "Infielder's Breakfast" Biscuit and Gravy, Daybreak Selections, Ingredients: PILLSBURY buttermilk biscuit, PIONEER biscuit gravy mix, PURNELLS sausage***Fresh Thru***Derby City Vending Louisville, KY 40206" Product is stamped: Fresh Thru 4/21/12 - 6/17/12 Class II During an FDA inspection of the firm on 6/12/2012, the firm was notified that they were missing the following allergen declarations from their labels: soy, milk, eggs and wheat. Derby City Vending Inc
Food Derby City Vending "Finish Line" Hand Made Chicken Salad Ingredients: 100% whole wheat bread, Fresh hand cut chicken breast, miracle whip, salt, pepper, celery, pickle relish Fresh Thru***Derby City Vending Louisville, KY 40206 Product is stamped: Fresh Thru 4/21/12 - 6/17/12 Class I During an FDA inspection of the firm on 6/12/2012, the firm was notified that they were missing the following allergen declarations from their labels: soy, milk, eggs and wheat. Derby City Vending Inc
Food Derby City Vending "Heckuva" Grilled Ham And Swiss Deli Selections Ingredients: Classic Pit-Style Ham, KLOSTERMAN sub bun, Swiss Cheese, mayonaise packet, SYSCO Clasic Redskin Potato Salad Fresh Thru***Derby City Vending Louisville, KY 40206 Product is stamped: Fresh Thru 4/21/12 - 6/17/12 Class I During an FDA inspection of the firm on 6/12/2012, the firm was notified that they were missing the following allergen declarations from their labels: soy, milk, eggs and wheat. Derby City Vending Inc
Devices DEXIS Imaging Suite - catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3 Radiological Image Processing System Catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3 Class II A condition can occur during renumbering of the patient database using the DEXCopy feature. When renumbering is being performed using the DEXCopy feature and multiple patients with an identical name are present, the software will assign all subsequent records to the first patient record, resulting in mixed patient records. In order for this problem to occur several conditions need to be met: 1) DEXIS Imaging Suite versions 10.0.0 - 10.0.3 must be installed, 2) The DEXCopy feature Mus thave been used to renumber the patient database, and 3) Two or more patients with identical names must be present within the database. Imaging Sciences International, LLC
Drugs CARDIOGEN-82 (Rubidium Rb 82 Generator), 140 millicurie, Rx Only, For Elution of sterile nonpyrogenic Rubidium Chloride Rb 82, Manufactured for: Bracco Diagnostics Inc. Princeton, NJ 08543 by Medi-Physics, Inc. South Plainfield, NJ 07080, NDC 0270-0091-01 Lot numbers 09101-121251 and 09101-121391 Class II GMP deviation; Sr-82 levels exceeded alert limit specification Bracco Diagnostics Inc
Drugs Levetiracetam Tablets, USP 500 mg, 500 count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-5615-05 Lot ZLMM12063, Exp March 2014 Class II Adulterated Presence of Foreign Tablets: Pharmaceutical manufacturer may have distributed foreign tablets in bottles of Levetiracetam Tablets, USP 500 mg. Mylan Pharmaceuticals Inc.
Food Approximately 5 lb bag of Pre-cooked Conch Fritters labeled in part: "***NEPTUNE'S CONCH FRITTERS PRECOOKED***Ingredients: Conch, Flour, Onions, Milk, Bell Peppers, Eggs, Garlic, Salt, Black Pepper, Lime Juice & Hot Pepper Sauce.***Packed by Triton Seafood Co. Miami, FL 33166***Pack: 125 Units Net Wt. 5# (approx.)*** W152BA, W152BB, W153BC, W152BD, W152BE, W162BA, W162BB, W162BC, W162BD, W162BE, W172BA, W172BB, W172BC, W172DB Class II Triton Seafood Co recalled their Neptune brand frozen Pre-cooked Conch Fritters and Conch Fritter Batter because the allergen, "Wheat" was not identified on the product label. Triton Seafood Co.
Food Approximately 5 lb plastic bucket of Conch Fritter Batter labeled in part: "***NEPTUNE'S CONCH FRITTERS ALL NATURAL***Ingredients: Conch, Flour, Onions, Milk, Bell Peppers, Eggs, Garlic, Salt, Black Pepper, Lime Juice, Hot Pepper Sauce.***Packed by Triton Seafood Co. Miami, FL 33166*** Net Weight 5 lbs.*** W152BA, W152BB, W153BC, W152BD, W152BE, W162BA, W162BB, W162BC, W162BD, W162BE, W172BA, W172BB, W172BC, W172DB Class II Triton Seafood Co recalled their Neptune brand frozen Pre-cooked Conch Fritters and Conch Fritter Batter because the allergen, "Wheat" was not identified on the product label. Triton Seafood Co.
Devices Sleek OTW***REF 426-1201X***Inflated Balloon Dia/mm***1.25***Inflated Balloon Length/mm***15***Usable Catheter Length/cm***150*** Lot 50027149***2013-09***Cordis*** Sleek***OTW***REF Cat. No. 426-1201X***PTA Dilatation Catheter***Cordis***Johnson Johnson Company***LOT Lot No. 50027149***Use by 2013-09***Sterile***EO***Method of Sterilization: ETO***ClearStream***Clearstream Technologies, Ltd.***Moyne Upper, Enniscorthy Co Wexford, Ireland***Phone: +353-53-92-37111***Fax: +353-53-92-37-100***Made in Ireland***Distributed by: Cordis Cashel***Cahir Road, Cashel, Co. Tipperary, Ireland***Tel: +353--(0)62-70000. The SLEEK OTW Percutaneous Transluminal Angioplasty (PTA) Peripheral Catheter Family is a non-reusable semi-compliant coaxial design catheter with a balloon mounted on its distal tip. The hub/"Y" connector consists of a through lumen, allowing the catheter to track over a guidewire, and a balloon port, used to inflate the balloon. The catheter shaft is small beneath the balloon achieve low profile. The distal tip is further tapered to accept the appropriate guidewire. Platinum iridium bands serve to locate the balloon under fluoroscopy. A 0.014" (0.356 mm) guidewire is recommended for use with the SLEEK OTW Catheter. Lot #50027149 Class II On 1/20/2011 Cordis Corporation , Miami Lakes, FL initiated a recall of their Sleek OTW PTA Dilatation Catheter Model #4261201X Lot #50027149 and Model #4261501X Lot #50026688. Product is incorrectly labeled. Cordis Corporation
Devices Sleek ***OTW ***Ref ***426-1501X***Inflated Balloon Dia/mm 1.5 Inflated Balloon Length/mm 15 Usable Catheter Length/cm 150***Lot 50026688***2013-09***Cordis***PTA Dilatation Catheter***Cordis***Johnson Johnson Company***Sterile***EO***Method of Sterilization: ETO***ClearStream***Clearstream Technologies, Ltd.***Moyne Upper, Enniscorthy Co Wexford, Ireland***Phone: +353-53-92-37111***Fax: +353-53-92-37-100***Made in Ireland***Distributed by: Cordis Cashel***Cahir Road, Cashel, Co. Tipperary, Ireland***". The SLEEK OTW Percutaneous Transluminal Angioplasty (PTA) Peripheral Catheter Family is a non-reusable semi-compliant coaxial design catheter with a balloon mounted on its distal tip. The hub/"Y" connector consists of a through lumen, allowing the catheter to track over a guidewire, and a balloon port, used to inflate the balloon. The catheter shaft is small beneath the balloon achieve low profile. The distal tip is further tapered to accept the appropriate guidewire. Platinum iridium bands serve to locate the balloon under fluoroscopy. A 0.014" (0.356 mm) guidewire is recommended for use with the SLEEK OTW Catheter. Lot #50026688. Class II On 1//20/2011 Cordis Corporation , Miami Lakes, FL initiated a recall of their Sleek OTW PTA Dilatation Catheter Model #4261201X Lot #50027149 and Model #4261501X Lot #50026688. Product is incorrectly labeled. Cordis Corporation
Devices KY LIQUIBEADS Vaginal Moisturizer; Distributed By: McNeil-PPC, Inc. Skillman, NJ 08558-9418; UPC 380041087704; 380040087958. Personal lubricant The following Lot Numbers were identified: 2721W; 2591W; 2321W; 1681W; 0921W; 0651W; 0471W; 0361W; 0221W; 0041W; 0110H; 0100H; 0090H; 0080H; 0030H; 0179H; 0159H; 0219H and 3489RT. Class II Johnson & Johnson Healthcare Products (JJHP) is voluntarily recalling this product to address FDA concerns that the product should have been cleared under a separate medical device application. This voluntary recall is not being conducted on the basis of any consumer safety or product performance issues related to K-Y LIQUIBEADS. JJHP received a Warning Letter on May 23, 2012 indicating that this device, KY Liquibeads Vaginal Moisturizer, is misbranded under the section 502(o) the Act, 21 U.S.C. 352(o), because we did not notify the agency of our intent to introduce the device into commercial distribution, as required by 510(k) of the Act, U.S.C. 360(k). The Warning Letter indicated that changes were made to the predicate device that would require submission of a new 510(k). Mc-NEIL-PPC, Inc.
Devices Invacare® I-Fit" Shower Chair (Models 9780, 9781, 9781-1), Invacare Corporation, Elyria, OH 44035. These shower chairs are designed for individuals who require seating support when bathing or showering and provide comfort and safety in the bathtub. 9780, 9781, 9781-1 Class II On August 6, 2012, Invacare voluntarily recalled the Invacare® I-Fit" Shower Chair (Models 9780, 9781, 9781-1) based on the return, quality and adverse event data received. Invacare Corporation
Devices BariAir Therapy System The BariAir Therapy System is a risk management treatment system designed for large and / or difficult-to-manage patients. The BariAir Therapy System provides low air-loss pressure management therapy, pulsation, percussion, Turn Assist. flexible patient positioning capabilities and built-in scales for patients weighing 300 Ib* to 850 Ib ([136*-386 kg] including accessories). The BariAir Therapy System is indicated to aid in: " Patients whose body weight and size pose a significant risk or care management issue to the patient or staff during the performance of routine nursing care. " Large patients weighing between 300 Ib* and 850 Ib (136*-386 kg) including accessories. " Large patients who are difficult to turn. " Preventing and treating pressure ulcers. " Large patients requiring percussion therapy. Multiple Serial Numbers with Model Numbers: 404000,405500, 405500RF Class II KCI has issued a medical device correction for the BariAir Therapy System Hand Pendent. The BariAir Therapy System is not designed to allow the patient to place the bed into the patient exit position. KCI has received complaints indicating that patients used the hand pendent to inadvertently place the BariAir Therapy System into a pseudo-exit position. In a small number of instances, this allowed the patient to unintentionally exit the therapy system, resulting in some patients receiving minor injuries. KCI USA, Inc.
Food Wildwood Emerald Valley Kitchen Organic Medium Salsa, 30 oz. Pack size 6/30 oz per case, 14 oz Pack size 6/14oz per case, Packaged in plastic cup, sealed with film and capped with plastic cap. Product labeling reads in part:" WILDWOOD Emerald Valley KITCHEN ORGANIC MEDIUM SALSA***MANUFACTURED BY PULMUONE FOODS USA, Inc. Fullerton, CA 92833***" UPC 0-52334-11665-0, Item # 0291623. UPC 0-52334-11653-7, Item # 0291638 Class II The firm recalled due to a potential non-safety quality concern related to a particular ingredient that was causing premature spoilage. Pulmuone Wildwood Inc
Food Wildwood Emerald Valley Kitchen Organic Mild Salsa, 14 oz. Pack size 6/14 oz per case. Packaged in plastic cup, sealed with film and capped with plastic cap. Product labeling reads in part:" WILDWOOD Emerald Valley KITCHEN ORGANIC MILD SALSA***NET WT. 14 OZ (850g)***MANUFACTURED BY PULMUONE FOODS USA, Inc. Fullerton, CA 92833***" UPC 0-52334-11659-9, Item # 0291628. Class II The firm recalled due to a potential non-safety quality concern related to a particular ingredient that was causing premature spoilage. Pulmuone Wildwood Inc
Food Wildwood Emerald Valley Kitchen Organic Hot Salsa, 14 oz. Pack size 6/14 oz per case. Packaged in plastic cup, sealed with film and capped with plastic cap. Product labeling reads in part:" WILDWOOD Emerald Valley KITCHEN ORGANIC HOT SALSA***NET WT. 14 OZ (850g)***MANUFACTURED BY PULMUONE FOODS USA, Inc. Fullerton, CA 92833***" UPC 0-52334-11660-5, Item # 0291635. Class II The firm recalled due to a potential non-safety quality concern related to a particular ingredient that was causing premature spoilage. Pulmuone Wildwood Inc
Food Wildwood Emerald Valley Kitchen Organic Medium Salsa - Canada (containing French in labeling), 397 mL. Pack size 6/14 oz per case. Packaged in plastic cup, sealed with film and capped with plastic cap. Product labeling reads in part:" WILDWOOD Emerald Valley KITCHEN ORGANIC MEDIUM SALSA***NET WT. 397mL, MANUFACTURED BY PULMUONE FOODS USA, Inc. Fullerton, CA 92833***". UPC 0-52334-11659-9, Item # 0291661. Class II The firm recalled due to a potential non-safety quality concern related to a particular ingredient that was causing premature spoilage. Pulmuone Wildwood Inc
Food Wildwood Emerald Valley Kitchen Organic Mild Salsa - Canada (containing French in labeling), 397 mL. Pack size 6/14 oz per case. Packaged in plastic cup, sealed with film and capped with plastic cap. Product labeling reads in part:" WILDWOOD Emerald Valley KITCHEN ORGANIC MILD SALSA***NET WT. 397mL, MANUFACTURED BY PULMUONE FOODS USA, Inc. Fullerton, CA 92833***". UPC 0-52334-11653-7, Item # 0291662. Class II The firm recalled due to a potential non-safety quality concern related to a particular ingredient that was causing premature spoilage. Pulmuone Wildwood Inc
Food Wildwood Organic Mild Salsa , 14 oz, Pack size 6/14 oz per case. Packaged in plastic cup, sealed with film and capped with plastic cap. Product labeling reads in part:" WILDWOOD ORGANIC salsa MILD ***NET WT. 14OZ, MANUFACTURED BY PULMUONE FOODS USA, Inc. Fullerton, CA 92833***". UPC 0-30871-33001-2, Item # 0291710. Class II The firm recalled due to a potential non-safety quality concern related to a particular ingredient that was causing premature spoilage. Pulmuone Wildwood Inc
Food Wildwood Organic Medium Salsa , 14 oz, Pack size 6/14 oz per case. Packaged in plastic cup, sealed with film and capped with plastic cap. Product labeling reads in part:" WILDWOOD ORGANIC salsa MILD ***NET WT. 14OZ, MANUFACTURED BY PULMUONE FOODS USA, Inc. Fullerton, CA 92833***". UPC 0-30871-33002-9, Item # 0291711. Class II The firm recalled due to a potential non-safety quality concern related to a particular ingredient that was causing premature spoilage. Pulmuone Wildwood Inc
Food Whey Protein Concentrate, Net Weight: 1lb (454g) Batch/Lot#0120712 Class I True Nutrition is recalling Whey Protein Isolate, Whey Protein Concentrate, and Hydrolyzed Whey Protein because they contain undeclared milk. MyoSci Technologies Inc.
Food Whey Protein Isolate Cold-Filtration, Net Weight: 1lb (454g) Batch/Lot#0030812 Class I True Nutrition is recalling Whey Protein Isolate, Whey Protein Concentrate, and Hydrolyzed Whey Protein because they contain undeclared milk. MyoSci Technologies Inc.
Food Whey Protein Isolate MicroFiltration, Net Weight: 1lb (454g) Batch/Lot#0040812 Class I True Nutrition is recalling Whey Protein Isolate, Whey Protein Concentrate, and Hydrolyzed Whey Protein because they contain undeclared milk. MyoSci Technologies Inc.
Food Whey Protein Isolate Cross-Flow Microfiltration, Net Weight: 1lb (454g) Batch/Lot#0730712 Class I True Nutrition is recalling Whey Protein Isolate, Whey Protein Concentrate, and Hydrolyzed Whey Protein because they contain undeclared milk. MyoSci Technologies Inc.
Food Hydrolyzed Whey Protein High Grade, Net Weight: 1lb (454g) Batch/Lot#0680512 Class I True Nutrition is recalling Whey Protein Isolate, Whey Protein Concentrate, and Hydrolyzed Whey Protein because they contain undeclared milk. MyoSci Technologies Inc.
Devices ***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source GCT Class II Linvatec Corporation dba ConMed Linvatec, Largo, FL initiated a recall of their products LS7700 Xenon Universal Light Source and LS7600 Xenon Light Source are intended to be used with an endoscope to provide illumination during endoscopic procedures. Linvatec Corp. dba ConMed Linvatec
Devices ***REF LS7700***Qty 1*** EC REP*** ConMed Linvatec Xenon Universal Light Source GCT Class II Linvatec Corporation dba ConMed Linvatec, Largo, FL initiated a recall of their products LS7700 Xenon Universal Light Source and LS7600 Xenon Light Source are intended to be used with an endoscope to provide illumination during endoscopic procedures. Linvatec Corp. dba ConMed Linvatec
Food Cucina Fresca Smoked Tomato Sauce. Product is packaged in a glass jar, net weight 24 oz. The UPC is 8-84337 00522-4 Lot 11002A and 11002B. Code is deciphered as: First digit = Shift; Second, Third, and Fourth digit = Julian date; Fifth digit = Production year Class I Smoked Tomato Sauce was recalled due to undeclared milk. The jars actually contain Cucina Fresca Tomato Vodka Sauce, which contains milk as an ingredient, but was mis-labeled as Smoked Tomato Sauce and the label does not declare milk. Cucina Fresca, Inc.
Devices Covidien Duet TRS 45 3.5 mm Universal Straight Single Use Loading Unit. Product Code: DUET4535. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas. All lot numbers Class II Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications Covidien LP
Devices Covidien Duet TRS 45 3.5 mm Universal Articulating Single Use Loading Unit. Product Code: DUET4535A. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas. All lot numbers Class II Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications. Covidien LP
Devices Covidien Duet TRS 45 4.8 mm Universal Straight Single Use Loading Unit. Product Code: DUET4548. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas. All lot numbers Class II Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications. Covidien LP
Devices Covidien Duet TRS 45 4.8 mm Universal Articulating Single Use Loading Unit. Product Code: DUET4548A. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas. All lot numbers Class II Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications Covidien LP
Devices Covidien Duet TRS 60 3.5 mm Universal Straight Single Use Loading Unit Product Code: DUET6035. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas. All lot numbers Class II Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications Covidien LP
Devices Covidien Duet TRS 60 3.5 mm Universal Articulating Single Use Loading Unit. Product Code: DUET6035A. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas. All lot numbers Class II Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications Covidien LP
Devices Covidien Duet TRS 60 4.8 mm Universal Straight Single Use Loading Unit. Product Code: DUET6048. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas. All lot numbers Class II Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications Covidien LP
Devices Covidien Duet TRS 60 4.8 mm Universal Articulating Single Use Loading Unit. Product Code: DUET6048A. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas. All lot numbers Class II Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications. Covidien LP
Biologics Cornea 121180100 Class II Corneas, recovered in a manner that may increase the risk of the introduction, transmission, or spread of communicable diseases, were distributed. Rocky Mountain Lions Eye Bank
Biologics Cornea 120114100 Class II Expired human cornea was distributed. Lions Eye Bank of Texas
Biologics Cornea 100791OD; 100791OS Class II Human corneas, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed. Upstate New York Transplant Services
Biologics Tendon 8169473 Class II Human tendon, with a swab culture positive for coagulase-negative Staphylococcus, was distributed. RTI Biologics, Inc.
Biologics Tendon 7576144; 7576145; 7576146; 7576147; 7576148; 7576149; 7576150 Class II Human tendons, with a culture positive for coagulase negative Staphylococcus, were distributed. RTI Biologics, Inc.
Food Daniella Mangoes May be identified by Daniella sticker with a PLU code of 3114, 4051, 4311, 4584 or 4959. All fruit had identifying stickers with label "Daniella" and one of the following PLU numbers: 3114, 4051, 4311, 4584 or 4959. Class I Firm is recalling certain lots of Daniella brand mangoes because they may be contaminated with Salmonella. Mangoes have been linked to a number of recent cases of salmonellosis in Canada, and may be linked to cases in California and perhaps other states Splendid Products
Devices Computed Tomography X-Ray Systems, (Brilliance 6, Brilliance 16, MX8000 Dual v. Exp, GEMINI Dual), Philips Healthcare Systems, Cleveland, OH. The Brilliance 6, 16 and MX8000 Dual v. Exp are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. GEMINI Dual is an imaging system that combines positron emission tomography (PET) and X-ray computed tomography. The GEMINI produces attenuation and non-attenuation corrected images of the distribution of PET radiopharmaceuticals in the head, body and total body as well as X-ray transmission images of these areas. The PET and CT images are registered and displayed in a fused format to provide combined PET and anatomical data at different angles for interpretation by trained health professionals. The PET and CT portions of the system can be used either as an integrated system or as a stand-alone PET or CT system. GEMINI can provide CT data suitable for use in attenuation correction. System Code #: 728130; Serial #: 8128, 8158 & 8369. System Code #: 728256; Serial #: 3695, 3703, 371 &, 3719. System Code #: 728246; Serial #: 3463, 3508, 3519, 3548, 3552, 3591, 3592, 3593, 3603, 3637, 3648, 3654, 3659, 3661, 3675, 3679, 3687, 3692, 5451, 5515, 5543, 5567, 5583, 5586, 5658,  ...
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Class II A bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumulator detaching from the tube housing assembly within the gantry. Philips Medical Systems (Cleveland) Inc
Food Product Name: Walnuts 160z. Brand Name: Markets of Meijer Meijer Distribution, Inc. Grand Rapids, MI49544 UPC 8-8692619782-2 Lot Number: 08 2150 Class II The firm was notified by a produce manager at one of the store locations that some of the bags from this lot of product contain pecans in addition to walnuts. Pecans are not listed in the ingredient statement and are not called out as an allergen. Meijer Distribution, Inc
Biologics Umbilical Cord Blood Stem Cells 111112016 Class II Umbilical cord blood stem cells, not tested in accordance with the manufacturer's instructions to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents, were distributed. Viacord Processing Laboratory
Biologics Cornea 2010063945; 2010063946 Class II Human corneas, recovered from a donor whose donor eligibility may have been been determined with inaccurate and/or incomplete donor records, were distributed. Lions Eye Institute for Transplant & Research, Inc.
Food Pistachios, Shelled Raw, 4 /2.5 Packed by Tropical Food Nut & Fruit- Orlando, FL 32811 GFS Item #866580 10015196182512, Lot 060412, 052912, Best By 02/03/13 Class I Gordon Food Service is recalling Tropical Food Nut & Fruit Shelled Raw Pistachios , because there is potential for the box to be mis-packed with chopped peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume this product. Gordon Food Service
Food ***Dulce De Leche "Del Campo"***Ice Cream "Base" (Flavor)***FB 23546***Mfg. Date***Keep Refrigerated at 40*f***Lot#***Net Wt 55 LBS***Indalco Food Corp., Miami, FLA (305) 620 1444*** Caramel milk spread is packed in white plastic pails of 55 lbs. under the firm's brand name "Del Campo". Lot # 721 and Lot # 728 Class I On June 28, 2011, Indalco Foods, Corp., Miami, FL initiated a voluntary recall of their product caramel milk spread ice cream base (dulce de leche heladero). Product labeling does not list Milk. Indalco Foods Corp.
Food Fruit Mixes: 1) Dining In® Super Fruit Medley,10.5oz, UPC 1122508396, Use by date 9/6/2012; 2) Ready Pac® Super Fruit Blend, 6oz , UPC 7774523076, Use by Dates 9/8/2012 or earlier, 9/6/2012 & 9/7/2012; 3) Ready Pac® Super Fruit Medley, 10.5oz, UPC 7774523746, Use by dates 9/8/2012 or earlier, 9/6/2012 & 9/7/2012. Ready Pac® Super Fruit Medley, 298g , UPC 7774524023, Use by dates 9/8/2012 or earlier and 9/8/2012. 1) Use by date 9/6/2012; 2) Use by dates 9/8/2012 or earlier, 9/6/2012 & 9/7/2012; 3) Use by dates 9/8/2012 or earlier and 9/8/2012 Class I Firm is voluntarily recalling, out of an abundance of caution, packaged fruit products containing mangoes, distributed through August 30th 2012, since they contain Daniella Brand mandoes, which have been recalled by supplier Splendid Products, due to potential contamination with Salmonella Braenderup. Ready Pac Foods Inc
Food Mango: 1) Dining In® Mango ,10.5oz , UPC 1122508640, Use by Date 9/7/2012; 2) Wawa® Mango, 8oz, UPC 2619106437, Use by dates 9/6/2012 or earlier. 1) Use by Date 9/7/2012; 2) Use by dates 9/6/2012 or earlier Class I Firm is voluntarily recalling, out of an abundance of caution, packaged fruit products containing mangoes, distributed through August 30th 2012, since they contain Daniella Brand mandoes, which have been recalled by supplier Splendid Products, due to potential contamination with Salmonella Braenderup. Ready Pac Foods Inc
Food Ready Pac® Fruit Tray Bien®, 907g UPC 7774523415 and Use by date 9/8/2012. Ready Pac® Fruit Tray Bien® 32oz UPC 7774521606, Use by date 9/8/2012 or earlier. UPC 7774523415 Use by date 9/8/2012. UPC 7774521606, Use by date 9/8/2012 or earlier. Class I Firm is voluntarily recalling, out of an abundance of caution, packaged fruit products containing mangoes, distributed through August 30th 2012, since they contain Daniella Brand mandoes, which have been recalled by supplier Splendid Products, due to potential contamination with Salmonella Braenderup Ready Pac Foods Inc
Food Ready Pac® Fruit & Chocolate Platter, 40oz , UPC 7774523673, Use by dates 9/6/2012 & 9/7/2012 UPC 7774523673, Use by dates 9/6/2012 & 9/7/2012 Class I Firm is voluntarily recalling, out of an abundance of caution, packaged fruit products containing mangoes, distributed through August 30th 2012, since they contain Daniella Brand mandoes, which have been recalled by supplier Splendid Products, due to potential contamination with Salmonella Braenderup. Ready Pac Foods Inc
Food Ready Pac® Sliced Mango, 10.5oz , UPC 7774523751, Use by dates 9/8/2012 or earlier, 9/6/2012 & 9/7/2012. Ready Pac® Sliced Mango, 32oz, UPC 0000088356, Use by dates 9/6/2012 & 9/7/2012. Ready Pac® Sliced Mango, 32 oz, UPC 7774522859, Use by dates 9/8/2012 or earlier and 9/6/2012 & 9/7/2012. UPC 7774523746, Use by dates 9/8/2012 or earlier, 9/6/2012 & 9/7/2012. UPC 7774524023, Use by dates 9/8/2012 or earlier and 9/8/2012. Class I Firm is voluntarily recalling, out of an abundance of caution, packaged fruit products containing mangoes, distributed through August 30th 2012, since they contain Daniella Brand mandoes, which have been recalled by supplier Splendid Products, due to potential contamination with Salmonella Braenderup. Ready Pac Foods Inc
Food Ready Pac® Mango Fandango", 32oz, UPC 7774524099, Use by dates 9/8/2012 or earlier and 9/6/2012 & 9/7/2012. Use by dates 9/8/2012 or earlier and 9/6/2012 & 9/7/2012. Class I Firm is voluntarily recalling, out of an abundance of caution, packaged fruit products containing mangoes, distributed through August 30th 2012, since they contain Daniella Brand mandoes, which have been recalled by supplier Splendid Products, due to potential contamination with Salmonella Braenderup. Ready Pac Foods Inc
Food Ready Pac® Gourmet Fruit Bowl, 64oz , UPC 7774522620, Use by dates 9/9/2012 or earlier and 9/7/2012 & 9/8/2012. UPC 7774522620, Use by dates 9/9/2012 or earlier and 9/7/2012 & 9/8/2012. Class I Firm is voluntarily recalling, out of an abundance of caution, packaged fruit products containing mangoes, distributed through August 30th 2012, since they contain Daniella Brand mandoes, which have been recalled by supplier Splendid Products, due to potential contamination with Salmonella Braenderup. Ready Pac Foods Inc
Food Ready Pac® Sweet Sunshine Platter, 37oz, UPC 7774524204, Use by dates 9/8/2012 or earlier and 9/6/2012 & 9/7/2012. UPC 7774524204, Use by dates 9/8/2012 or earlier and 9/6/2012 & 9/7/2012. Class I Firm is voluntarily recalling, out of an abundance of caution, packaged fruit products containing mangoes, distributed through August 30th 2012, since they contain Daniella Brand mandoes, which have been recalled by supplier Splendid Products, due to potential contamination with Salmonella Braenderup. Ready Pac Foods Inc
Food Ready Pac® Seasons Choice", 32oz, UPC 7774524276, Use by dates 9/8/2012 or earlier and 9/7/2012 & 9/8/2012. UPC 7774524276, Use by dates 9/8/2012 or earlier and 9/7/2012 & 9/8/2012. Class I Firm is voluntarily recalling, out of an abundance of caution, packaged fruit products containing mangoes, distributed through August 30th 2012, since they contain Daniella Brand mandoes, which have been recalled by supplier Splendid Products, due to potential contamination with Salmonella Braenderup. Ready Pac Foods Inc
Food Starbucks® Seasonal Harvest Fruit Blend, 6oz, UPC 6211171390, Use by dates 8/22/2012 through 9/7/2012 and 9/4/2012 & 9/5/2012. UPC 6211171390, Use by dates 8/22/2012 through 9/7/2012 and 9/4/2012 & 9/5/2012. Class I Firm is voluntarily recalling, out of an abundance of caution, packaged fruit products containing mangoes, distributed through August 30th 2012, since they contain Daniella Brand mandoes, which have been recalled by supplier Splendid Products, due to potential contamination with Salmonella Braenderup. Ready Pac Foods Inc
Food Walmart® Super Fruit Blend, 10oz, UPC 7774523327, Use by dates 9/6/2012 & 9/7/2012. UPC 7774523327, Use by dates 9/6/2012 & 9/7/2012. Class I Firm is voluntarily recalling, out of an abundance of caution, packaged fruit products containing mangoes, distributed through August 30th 2012, since they contain Daniella Brand mandoes, which have been recalled by supplier Splendid Products, due to potential contamination with Salmonella Braenderup. Ready Pac Foods Inc
Food Walmart® Seasonal Blend ,16oz, UPC 7774523761, Use by dates 9/6/2012 & 9/7/2012. Walmart® Seasonal Blend, 32oz, UPC 7774523765, Use by dates 9/6/2012 & 9/7/2012. UPC 7774523761, Use by dates 9/6/2012 & 9/7/2012. UPC 7774523765, Use by dates 9/6/2012 & 9/7/2012. Class I Firm is voluntarily recalling, out of an abundance of caution, packaged fruit products containing mangoes, distributed through August 30th 2012, since they contain Daniella Brand mandoes, which have been recalled by supplier Splendid Products, due to potential contamination with Salmonella Braenderup. Ready Pac Foods Inc
Devices Alere Triage TOX Drug Screen 9 Panel, P/N: 94402. The Alere Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Alere Triage Meters for the qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine, THC and tricyclic antidepressants in urine. The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or above therapeutic doses. Lot Codes: K51245RB, W51022RB, W51207RB Class II Alere San Diego is recalling Alere Triage TOX Drug Screen because there is a possibility that after installing the code chip provided with the affected lots: AMP, BAR, and PCP, the threshold ranges may not be consistently set correctly in all meters. Alere San Diego, Inc.
Devices Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature. U.S. Lot #: 737538, 737576, 738162, 738486, 738641, 739286, 739518, 739837, 740078, 740090, 740306, 740310, 740575, 740579, 740583, 740591, 740599, 740824, 740828, 740832, 740836, 742024, 742028, 742032, 742036, 742040, 742234, 742238, 742246, 742250, 742509, 742513, 742517, 742521, 742759, 742767, 742775, 742783, 742932, 742936, 742940, 742944, 742948, 742952, 742956, 743092, 743096,  ...
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Class II Abbott Vascular is recalling the Armada 35 and Armada 35 LL PTA Catheters because they have discovered that some devices may exhibit difficulty inflating and/or deflating. Abbott Vascular
Devices Varian brand Eclipse Treatment Planning System, Model Number: H48; Eclipse 8.9 and 10.0 Reference/FSCA Identifier: CP-08922; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithim is specifically indicated for planning proton treatment of neoplasms of the eyes. CP-08922: LIST OF SERIAL NUMBERS: H480001 ,H480130 ,H480301 ,H480446 ,H480623 ,H480795 ,H480976 ,H481088 ,H481222 ,H481382 ,H481544 ,H481777 ,H481931 ,H480002 ,H480131 ,H480302 ,H480448 ,H480624 ,H480798 ,H480981 ,H481089 ,H481229 ,H481383 ,H481545 ,H481778 ,H481932 ,H480008 ,H480132 ,H480305 ,H480449 ,H480627 ,H480808 ,H480982 ,H481090 ,H481230 ,H481389 ,H481556 ,H481787 ,H481935 ,H480009 ,H480133 ,H480312 ,H480450 ,H480628 ,H480814  ...
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Class II Varian has identified an anomaly with the Eclipse Treatment Planning where an outdated assigned Hounsfield Unit [HU] value can be used for dose calculation when the clock on the Eclipse Client Workstation is not synchronized with the Database/System Server. Treatment of the patient using these values can therefore lead to under or over-dose. Varian Medical Systems, Inc. Oncology Systems
Drugs Atrovent HFA Inhalation Aerosol, (ipratropium bromide) 12.9 grams, 200 metered actuations, Rx only, Packaged Exclusively by: Dispensing Solutions, Inc., Santa Ana, CA --- NDC 68258-8952-01, DSI product #8A0947 Lot # F23989, F22311 Class II Label Mix up; side panel of sticker label applied by Dispensing Solutions Inc. incorrectly indicates product name as Ventolin HFA 90 mcg instead of correctly as Atrovent HFA 12.9 grams Inhalation Aerosol Dispensing Solutions, Inc
Devices Embolectomy Catheters (Models A44XX, A4FXX, CE0XXXST, and CE0XXX): Model Numbers & Description: A4402, 3F-40CM, SYNTEL RT-EMB; A4403, 3F-80CM, SYNTEL RT-EMB; A4404, 4F-40CM, SYNTEL RT-EMB; A4405, 4F-80CM, SYNTEL RT-EMB; A4406, 5F-80CM, SYNTEL RT-EMB; A4407, 6F-80CM, SYNTEL RT-EMB; A4408, 7F-80CM, SYNTEL RT-EMB; A4F00, 2F-60CM (PREM) SYNTEL CATHETER; A4F01, 2F-80CM, (PREM) SYNTEL CATHETER; A4F02, 3F-40CM, (PREM) SYNTEL CATHETER; A4F03, 3F-80CM, (PREM) SYNTEL CATHETER; A4F04, 4F-40CM, (PREM) SYNTEL CATHETER; A4F05, 4F-80CM, (PREM) SYNTEL CATHETER; A4F06, 5F-80CM, (PREM) SYNTEL CATHETER; A4F07, 6F-80CM, (PREM) SYNTEL CATHETER; A4F08, 7F-80CM, (PREM) SYNTEL CATHETER; CE0260ST, L2F-60CM PREM SYNTEL CATH; CE0280ST, L2F-80CM PREM SYNTEL CATH; CE0340ST, 3F-40cm (PREM) SYNTEL CATHETER; CE0380ST, 3F-80CM PREM SYNTEL CATH; CE0440ST, 4F-40CM PREM SYNTEL CATH; CE0480ST, 4F-80CM PREM SYNTEL CATH; CE0580ST, 5F-80CM PREM SYNTEL CATH; CE0680ST, 6F-80cm (PREM) SYNTEL CATHETER; CE0780ST, 7F-80CM PREM SYNTEL CATH; CE0340, 3F-40cm, SYNTEL RT-EMB; CE0380, 3F-80cm, SYNTEL RT-EMB; CE0440, 4F-40cm, SYNTEL RT-EMB; CE0480, 4F-80cm, SYNTEL RT-EMB; CE0580, 5F-80cm, SYNTEL RT-EMB; CE0680, 6F-80cm, SYNTEL RT-EMB; CE0780, 7F-80cm SYNTEL RT-EMB. BARD Embolectomy Catheters are indicated for the removal of emboli and thrombi from the peripheral arterial system. These devices consist of a catheter body with a latex-free balloon on the distal end and an inflation hub on the proximal end. Model Numbers: Lot Numbers A4402: 1157054, 1163804, 1170473. A4403: 1157060, 1162689, 1166031, 1169109. A4404: 1160223, 1163803, 1166725, 1171181. A4405: 1155214, 1157053, 1161472, 1162967, 1164628, 1168912. A4406: 1155428, 1162945, 1167745, 1170042. A4407: 1154478, 1162866, 1168604. A4408: 1163626. A4F00: 1164152, 1164627, 1168666. A4F01: 1156256, 1160007, 1163628, 1168231. A4F02: 1156522, 1161792, 1170399. A4F03: 1155855, 1157052, 1161793, 1160310, 1159725, 1163215, 1163961, 1167855, 1169632, 1164626, 1165853. A4F04:  ...
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Class II Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have a potential for packaging particulate matter to reside on the product. Applied Medical Resources Corp
Devices Biliary Catheters (Models A47XX and CB0XXXXX): Model Numbers & Description: A4752, SYNTEL BILIARY 5F-23CM CATHETER; A4754, SYNTEL BILIARY 5F-40CM CATHETER; A4762, SYNTEL BILIARY 6F-23CM CATHETER; CB052308, SYNTEL BILIARY 5F-23CM CATH; CB054008, SYNTEL BILIARY 5F-40CM CATH; CB062313, SYNTEL BILIARY 6F-23CM CATH. Biliary Catheters are indicated for the removal of stones and ductal debris from the biliary system. Model Numbers: Lot Numbers A4752: 1165670. A4754: 1156762. A4762: 1155852, 1165674. CB052308: 1164350. CB054008: 1164305. CB062313: 1164306. Class II Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have a potential for packaging particulate matter to reside on the product. Applied Medical Resources Corp
Devices Irrigation Catheters (Models IRR-XXX-XX): Model Numbers & Description: IRR-023-10F,CATHETER IRRIGATION 10F 23CM; IRR-080-4F, CATHETER, IRRIGATION 4F 80CM; IRR-080-6F, CATHETER, IRRIGATION 6F 80CM. Irrigation Catheters are indicated for irrigation in the peripheral vascular system and biliary tree. Model Numbers: Lot Numbers IRR-023-10F: 1158230. IRR-080-4F: 1156082, 1170185, 1164648. IRR-080-6F: 1158960. Class II Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have a potential for packaging particulate matter to reside on the product. Applied Medical Resources Corp
Devices Catheter Irrigation Set labeled in part: ***24K Arthroscopy Outflow/Suction Tubing Set*** This Arthroscopy Tubing Set is intended for use, in conjunction with the ConMed Linvatec 24k Pump, for pump-induced outflow and/or suction of fluid from the joint during arthroscopic procedures. Catalog # 24k100 Lot #: 20853-000 20854-000 20855-000 21791-000 22172-000 22414-000 22513-000 22667-000 22724-000 22725-000 23606-000 23912 23912-000 23971-000 24177-000 24296-000 24348-000 24373-000 24476-000 24559-000 24671-000 24703-000 24905-000 25668-000 25794-000 25931-000 26025-000 26041-000 26294-000 26448-000 26486-000 27130-000 27255 27255-000 27322 27520 Class II ConMed Linvatec recalled their 24k Arthroscopy Outflow/Suction Tubing Set (Product Number 24k100)because there is a possibility that the product may have a breach in the Tyvek seal that could potentially compromise the sterility of the contents. Linvatec Corp. dba ConMed Linvatec
Devices Philips Digital Diagnost-Mobile Detector Holder for Digital Diagnost (Single Detector, Dual Detector, Release 3) System codes: 712020, 712022, 712025 This system is used for making X-ray exposures for diagnostics. Serial Numbers: SN10000053 SN11000644 SN10000648 SN10000649 SN11000226 SN10000703 SN11000032 SN10000407 SN11000105 SN11000112 SN11000212 SN11000231 SN11000030 SN10000468 SN11000146 SN11000217 SN11000238 SN11000407 SN11000154 SN10000297 SN10000515 SN11000129 SN11000266 SN11000412 SN11000442 SN11000063 SN11000441 SN10000416 SN10000414 SN10000424 SN11000034 SN10000018 SN11000050 SN10000113 SN10000442 SN11000057 SN11000419 SN10000482 SN10000670 SN10000690 SN10000689 SN10000694 SN11000461 SN10000544 SN11000095 SN11000329 SN11000464 SN10000554 SN10000635 SN10000107 SN10000413 SN10000557 SN11000092 SN11000100 SN11000118 SN11000145 SN11000161 SN11000193 SN11000194 SN11000228 SN11000294 SN11000371 SN10000038 SN10000101 SN10000102 SN10000641 SN10000664 SN11000027 SN10000537 SN10000650 SN11000130 SN11000142 SN11000216 SN11000269 SN11000286 SN11000288 SN11000311 SN11000320 SN10000363 SN10000246 SN10000512 SN11000033 SN11000053 SN11000080 SN11000271 SN11000478 SN11000474 SN11000013 SN11000005 SN11000008 SN11000004 SN11000141 SN11000007 Class II The Wireless Portable Detector (WPD) is not fixed securely inside the Mobile Detector Holder and may fall down Philips Healthcare Inc.
Devices Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, Rx only, Distributed by Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, Manufactured by Greathbatch Medical, 2300 Berkshire Lane North, Minneapolis, MN 55441. To facilitate transvenous introduction of diagnostic / therapeutic catheters into the vasculature and into the chambers of the heart. Q2112752, Q2110939, Q2130137, Q2131250, Q2130212, Q2150143, W2162515, W2163769, W2160626, W2175891, W2172722, W2184492, W2196366, W2184490, W2205843 Class II During the investigation of four returned Z Flex 270 Steerable Sheaths that were used with cardiac cryoablation balloon catheters, the internal PTFE sheath liners were found to display varying degrees of damage that could pose an embolic risk to a patient. Greatbatch Medical
Food Seasoned Clams, 240 grams not available. Class II M & K Trading is recalling Korean Molluscan Shellfish because the product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. M & K Trading Inc
Food Sam's Club Chunky Cinnamon Streusel, Net Wt 25 lb, in white plastic pails, Manufactured for Sam's Club, Bentonville, AR 72716, Best if stored in a cool, dry location between 65 - 75 degrees Farenheit. 2-203-19-81; 2-203-19-82; 2-203-19-83; 2-223-19-01; 2-223-19-02; 2-223-19-03; 2-223-19-04; 2-236-19-83; 2-236-19-84; 2-236-19-87 Class I Dawn Foods is recalling 251, 25 lb pails of Chunky Cinnamon Streusel due to the omission of the major allergens milk and soy from the finished product label. Dawn Food Products, Incorporated
Devices Progel Pleural Air Leak Sealant, Model #: PGPS002 Lot #: 111202-002 Product Usage: The Progel Pleural Air Leak Sealant is indicated for application to visceral pleura during an open thoracotomy after standard visceral pleural closure with, for example, sutures or staples, of visible air leaks (;::2mm) incurred during open resection of lung parenchyma. Model #: PGPS002 Lot #: 111202-002 Class II Product was distributed with an incorrect expiration date. Product was labeled with an expiration date of 2013-04 and should have been labeled with 2012-09. Neomend Inc
Devices TSX-301A/2 Aquilion One CT System. The TSX-30IAl2 is a whole body CT scanner. This device captures cross sectional volume data sets. The device consists of a gantry, patient couch (table) and peripheral cabinets used for data processing and display. This device is intended to produce cross sectional volume sets of the anatomy. Additionally the system, when used by a trained professional, is capable of proving data for dynamic and perfusion studies of organs and extremities. Item number TSX-301 A/2D Serial Numbers: 2DA0792004, 2DA07X2005, 2DA07Y2010, 2DA0792002, 2DA07X2008, 2DA0842023. Class II The SureStart function may not operate in the usual manner, and you may obtain abnormal analysis results when using the cerebral blood flow analysis function. Toshiba American Medical Systems Inc
Devices Hologic Fluoroscan Mini C-Arm Model with InSight2, Software version 4.0 and 4.0.1 The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with general fluoroscopic visualization of a patient, including but not limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation. Software version 4.0 and 4.0.1 Class II InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may be flipped 180°around vertical axis. InSight FD, version 5.0.1 and 5.0.2 - DICOM images stored in PACS may be lipped 180° around vertical axis as well as 180° around a horizontal axis. Hologic, Inc.
Devices Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1and 5.0.2 The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with general fluoroscopic visualization of a patient, including but not limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation. Software version 5.0.1and 5.0.2 Class II Fluoroscan Mini C-Arm models -InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may be flipped 180°around vertical axis. InSight FD, version 5.0.1 and 5.0.2 - DICOM images stored in PACS may be lipped 180° around vertical axis as well as 180° around a horizontal axis. Hologic, Inc.
Devices SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing name RayAutoplan, aka t-RayAutoplan, commercial name (TomoTherapy) SharePlan Intended use: t-RayAutoplan is a software that, based on the planned dose distribution from a TomoPlan treatment planning system, generates a family of individually optimized IMRT plans and presents their characteristics to the user in a GUI. Among the generated plans, the user selects and clinically approves a treatment plan and exports it electronically to DICOM, for subsequent treatment of the patient. The intended users of t-RayAutoplan shall be clinically qualified staff, such as medical physicists, medical doctors or dosimetrists. version 1.2.1 (build number 1.3.1.10). Class II This notice concerns behavior of the SharePlan that may be unexpected and not clearly described in the user manual. This behavior has not caused patient mistreatment or other incidents. However, the described user actions must be adhered to for best agreement between treatment plan evaluation and the clinical outcome of the delivered treatment. The behavior appears, when importing RFA-files (.asc). In such cases, special notice has to be taken of the coordinate system used. The correction is to modify the labelling. RAYSEARCH LABORATORIES AB
Devices UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. Product Usage: The UltraFlow HPC Flow Directed Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media. Lot # 9374298 Class II The recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Directed Micro Catheters and Marathon Flow Directed Micro Catheters may have been mislabeled. Micro Therapeutics Inc, Dba Ev3 Neurovascular
Devices Marathon Flow Directed Micro Catheter, Model #105-5055. Product Usage: The Marathon Flow Directed Micro Catheter is intended to access the peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media. Lot # 9374210 Class II The recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Directed Micro Catheters and Marathon Flow Directed Micro Catheters may have been mislabeled. Micro Therapeutics Inc, Dba Ev3 Neurovascular
Drugs 5% Dextrose Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E0062, NDC 0338-6346-02; b) 500 mL AVIVA Container, product code 6E0063, NDC 0338-6346-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA Lot #: a) C841114, C841254, Exp 09/12; C842229, C842898, C843037, C843326, C844209, Exp 10/12; C844456, C844928, C846089, C846246, C847178, Exp 11/12; C848044, C848804, C849869, C849810, C850313, Exp 12/12; C852574, C852673, C853168, C853275, C853473, Exp 01/13; C854331, C855098, C855551, Exp 02/13; C856690, C856815, C857813, Exp 03/13; C858829, C858951, C859884, C860049, C860304,  ...
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Class II Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP). Baxter Healthcare Corp.
Drugs 10% Dextrose Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 6E0163, NDC 0338-6347-03 Lot #: C832840, Exp 02/13 Class II Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP). Baxter Healthcare Corp.
Drugs 5% Dextrose and 0.45% Sodium Chloride Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 6E0173, NDC 0338-6308-03 Lot #: C828814, Exp 12/12; C841551, Exp 04/13 Class II Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP). Baxter Healthcare Corp.
Drugs 0.9% Sodium Chloride Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E1322, NDC 0338-6304-02; b) 500 mL AVIVA Container, product code 6E1323, NDC 0338-6304-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA Lot #: a) C840892, C841007, C841403, Exp 09/12; C842377, C842757, C843748, C843946, Exp 10/12; C844332, C845065, C845198, C845347, C846873, C847301, C847608, Exp 11/12; C848481, C848937, C849554, C850180, Exp 12/12; C850966, C851097, C851212, C852459, C853044, C853614, Exp 01/13; C853747, C854455, C854711, C854836, C854943, C856013, C856138, Exp 02/13; C856948, C858027, Exp 03/13;  ...
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Class II Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP). Baxter Healthcare Corp.
Drugs Lactated Ringer's Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E2322B, NDC 0338-6307-02; b) 500 mL AVIVA Container, product code 6E2323, NDC 0338-6307-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA Lot #: a) C847749, Exp 11/12; C847897, Exp 12/12; C860668, Exp 04/13; b) C855445, Exp 09/13; C861492, Exp 12/13 Class II Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP). Baxter Healthcare Corp.
Devices Siemens Magnetom Skyra, Verio, Spectra and Biograph MMR Nuclear Magnetic Resonance Imaging System and Tomographic Imager Model numbers: 10276755 (Verio), 10684333 (Verio Dot), 10684334 (Verio Dot upgrade), 10432915 (Skyra), 10655588 (Spectra), and 10433372 (Biograph mMR) Class II When positioning the Flex Large 4 Coil (part No. 8625761) off-center in left-right direction as it is used for example for hip and shoulder imaging and, in addition at an off-center position with respect to the head-foot direction, the coil can heat up in the area of the electronic housing (white plastic lids). Siemens Medical Solutions USA, Inc
Drugs Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 50 mL Single patient infusion vial, 500 mg/50 mL (10 mg/mL), NDC 0409-4699-33; c) 100 mL Single patient infusion vial, 1 g/100 mL (10 mg/mL), NDC 0409-4699-24; Rx only, Hospira, Inc., Lake Forest, IL 60045 USA Lot No: a) 93-857-DJ, 93-896-DJ, Exp 1SEP2012; 04-515-DJ, Exp 1APR2013; 06-802-DJ, Exp 1JUN2013; b) 01-175-DJ, Exp 1JAN2013; 04-565-DJ, Exp 1APR2013; c) 03-388-DJ, Exp 1MAR2013; The lot number may be followed by 01 or 02 Class II Presence of Particulate Matter: A single visible particulate was observed and confirmed in sample bottles of the recalled lots during retain inspection. Hospira Inc.
Drugs NAPROXEN TABLETS USP, 500 mg, 100-count Tablets per bottle, Rx only, Manufactured by: Glenmark Generics Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Generics Inc., USA, Mahwah, NJ 07430; NDC 68462-190-01. Lot #: 02112930, 02112934, 02112941, Exp 09/14; 2112985, 02112986, 02113334, Exp 10/14; 02113360, 02113372, 02113420, 02113606, 02113663, 02113664, Exp 11/14. Class II Labeling: Label Mix-Up: Bottles labeled as Naproxen Tablets USP, 500 mg, 100-count may contain 90-count Pravastatin Sodium Tablets, 40 mg. Glenmark Generics Inc., USA
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