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

Enforcement Report - Week of July 3, 2013

  • Print
  • Share
  • E-mail
-
Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Source Plasma 368038850 Class II Blood products, collected from a donor whose annual physical exam was not performed, were distributed. Talecris Plasma Resources Inc Dba International Bioresources
Biologics Red Blood Cells Deglycerolized 02FN07700 Class II Blood products, collected from donors that used the incorrect version of the BDR, were distributed. American Red Cross Blood Services
Biologics Red Blood Cells 02FN07716; 02FN07717; 02FN07718 Class II Blood products, collected from donors that used the incorrect version of the BDR, were distributed. American Red Cross Blood Services
Biologics Red Blood Cells Leukocytes Reduced Irradiated 02FN07714; 02FN07715 Class II Blood products, collected from donors that used the incorrect version of the BDR, were distributed. American Red Cross Blood Services
Biologics Fresh Frozen Plasma 02FN07716; 02FN07717; 02FN07718 Class II Blood products, collected from donors that used the incorrect version of the BDR, were distributed. American Red Cross Blood Services
Biologics Blood and Blood Products for Reprocessing 02FN07700; 02FN07701; 02FN07713; 02FN07714; 02FN07715 Class III Blood products, collected from donors that used the incorrect version of the BDR, were distributed. American Red Cross Blood Services
Biologics Red Blood Cells Leukocytes Reduced 02FN07713 Class II Blood products, collected from donors that used the incorrect version of the BDR, were distributed. American Red Cross Blood Services
Biologics Source Plasma 05MTNA8618 Class II Blood product, collected from a donor who was previously HIV-1/2 reactive, was distributed. BioLife Plasma Services L.P.
Biologics Red Blood Cells Leukocytes Reduced 02LC64792 ;02LC68105 ;02LC72471 Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. American Red Cross Blood Services
Biologics Fresh Frozen Plasma W045006024544; W045006015544 Class III Blood products, stored without continuous monitoring and possibly exposed to unacceptable temperatures, were distributed. Community Blood Center Of Gtr KC
Biologics Platelets Pheresis Leukocytes Reduced W045006905629 Class III Blood products, stored without continuous monitoring and possibly exposed to unacceptable temperatures, were distributed. Community Blood Center Of Gtr KC
Biologics Platelets Pheresis Leukocytes Reduced Irradiated 20LG14558, 20LG14559, 20LG14559, 20LG14565, 20LG14566, 20LR25072, 20LR25075, 20LR25075, 20LR25077, 20LR25082, 20LR25082, 20LR25083, 20LR25083, 20LR25084, 20LR25084, 20LR25085, 20R 21322, Class III Platelets, possibly exposed to unacceptable temperatures, were distributed. American National Red Cross (The)
Biologics Platelets Pheresis Leukocytes Reduced 20LG14560, 21LG14560, 20LG14561, 20LG14561, 20LG14562, 20LG14564, 20LG14568, 20LR21315, 20LR21315, 20LR25072, 20LR25073, 20LR25073, 20LR25074, 20LR25076, 20LR25076, 20LR25079, 20LR25079, 20LR25086, 20LR25087, 20LR25088, 20P 34149, 20P 34175, 20R 21315, 20R 21322, Class III Platelets, possibly exposed to unacceptable temperatures, were distributed. American National Red Cross (The)
Biologics Source Plasma 4270046590 Class II Blood product, collected from a donor whose physical exam was incomplete, was distributed. Csl Plasma Inc
Biologics Red Blood Cells 2316124 Class II Blood products, collected from a donor who was previously deferred, due to testing Anti-HTLV reactive, were distributed.. Community Blood Centers of South Florida, Inc.
Biologics Platelets 2316124 Class II Blood products, collected from a donor who was previously deferred, due to testing Anti-HTLV reactive, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Platelets Leukocytes Reduced Irradiated 2528930A; 2528930B. Class II Blood product, possibly contaminated with bacteria, was distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells Leukocytes Reduced 21KS56402, 21KS56406, 21KS56409, 21KS56413, 21KS56414, 21KS56417, 21KS56419, 21KS56428, 21KS56431, 21KS56432, 21KS56433, 21KS56439, 21KS56443, 21KS56447, 21KS56455, 21KS56459, 21KS56460, 21KS56468, 21KS56470, 21KS56472, 21KS56473, 21KS56475, 21KS56477, 21KS56482, 21KS56487, 21KS56489, 21KS56490, 21KS56500, 21KS56506, 21KS56507, 21KS56512, 21KS56514, 21KS56515, 21KS56680, 21KS56685, 21KS56687, 21KS56691, 21KS56693, 21KS56703, 21KS56707, 21KS56711, 21KS56713, 21KS56720, 21KS56723, 21KS56726, 21KS56729, 21KS56732, 21KS56734, 21KS56739, 21KS56740,  ...
More
Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. American National Red Cross
Biologics Plasma Frozen 21KS56404, 21KS56409, 21KS56414, 21KS56419, 21KS56431, 21KS56455, 21KS56459, 21KS56470, 21KS56475, 21KS56707, 21KS56711, 21KS56713, 21KS56715, 21KS56726, 21KS56732, 21KS56745, 21KS56746, 21KS56801, 21KS58221, 21KS58224, 21KS58231, 21KS58255, 21KS58259, 21KS58264, 21KS58271, 21KS58274, 21KS58285, 21KS58292, 21KS58343, 21KS58355, 21KS58358, 21KS58370, 21KS58376, 21KS58379, 21KS58392, 21KS58398, 21KS58407, 21KS58413, 21KS58422, 21KS58426, 21KS58429, 21KS58431, 21KS58434, 21KS58435, 21KS58442, 21KS58445, 21KS58473, 21KS58496, 21KW47408, 21KW47413,  ...
More
Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. American National Red Cross
Biologics Red Blood Cells 21KS56466, 21KS56479, 21KS56483, 21KS56503, 21KS61478, 21KW47433, 21LC70594, 21LJ41078, 21LK29140, 21W71706, 21W71713, 21W71718, 21W71730, 21W71732, 21W71734, 21W71711, 21KW47408, 21KW47413, 21KS60140, 21KS68252, 21KS68255, 21KS68256, 21KS68257, 21LC70589, 21LC70613, 21LC70626, 21LC70637, 21LC70647, 21LC70660, 21W71695, 21W71696, 21W71723, 21W71728 Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. American National Red Cross
Biologics Red Blood Cells Leukocytes Reduced Washed 21KS58453 Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. American National Red Cross
Biologics Red Blood Cells Leukocytes Reduced Irradiated 21KS58396, 21KS58499, 21KS60090, 21KS61430, 21KS61443, 21KS62656, 21KS64851, 21KS70967, 21KW49314, 21KW50110, 21KW50979, 21KW51223, 21KW51908, 21KW52471, 21KW53556, 21KW53584, 21KW55746, 21KW55747, 21KW59204, 21KW60255, 21KW60262, 21KW60416, 21LC70653, 21LC70665, 21LC71006, 21LC71358, 21LC72748, 21LC77819, 21LC78996, 21LC79018, 21LC79912, 21LC80778, 21LC80797, 21LC80815, 21LC80841, 21LC80851, 21LC82030, 21LC82039, 21LC82068, 21LC82590, 21LC82603, 21LC82635, 21LC82639, 21LC82655, 21LC84390, 21LC84421, 21LC84533, 21LC99782, 21LC99827, 21LG38733,  ...
More
Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. American National Red Cross
Biologics Cryoprecipitated AHF 21KS56479, 21KS56482, 21KS56483, 21KS56487, 21KS56512, 21KS57422, 21KS57766, 21KS57772, 21KS57784, 21KS57807, 21KS57810, 21KS57815, 21KS57828, 21KS57832, 21KS57836, 21KS57838, 21KS57840, 21KS57843, 21KS57845, 21KS57853, 21KS57856, 21KS57857, 21KS57858, 21KS58748, 21KS58767, 21KS58769, 21KS58775, 21KS58779, 21KS58792, 21KS58795, 21KS58803, 21KS58835, 21KS58842, 21KS58849, 21KS58860, 21KS58870, 21KS59265, 21KS59300, 21KS59318, 21KS59341, 21KS59352, 21KS59356, 21KS59359, 21KS59370, 21KS59385, 21KS59390, 21KS60890, 21KS60892, 21KS60895, 21KS60898,  ...
More
Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. American National Red Cross
Biologics Cryoprecipitated AHF, Pooled 21KS57753 Pool 17274, 21KS57755 Pool 17274, 21KS57760 Pool 17275, 21KS58872 Pool 17553, 21KS58873 Pool 17554, 21KS61505 Pool 17952, 21KS61508 Pool 17952, 21KS61522 Pool 17952, 21KS61523 Pool 17953, 21KS62677 Pool 18251, 21KS62684 Pool 18250, 21KS62813 Pool 18270, 21KS62820 Pool 18269, 21KS62839 Pool 18264, 21KS62843 Pool18263, 21KS63743 Pool 18572, 21KS63751 Pool 18573,  ...
More
Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. American National Red Cross
Biologics Plasma Frozen Cryoprecipitate Reduced 21KS58803, 21KS59300, 21KS61529, 21KW49273, 21KW49279, 21KW49688, 21KW49706, 21KW50019, 21KW50061, 21KW50080, 21KW50110, 21KW50112, 21KW50114, 21KW50116, 21KW50508, 21KW50512, 21KW50513, 21KW50518, 21KW50539, 21KW50589, 21KW50634, 21KW50886, 21KW50914, 21KW50925, 21KW50927, 21KW50933, 21KW51259, 21KW51658, 21KW52605, 21KW52608, 21KW53096, 21KW53115, 21KW53456, 21KW53464, 21KW53475, 21KW53483, 21KW55487, 21LC71270, 21LC71272, 21LC71276, 21LC71297, 21LC71363, 21LC71377, 21LC71379, 21LC71568, 21LC71571, 21LC71594, 21LC71595, 21LC71612, 21LC71629,  ...
More
Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. American National Red Cross
Biologics Platelets Leukocytes Reduced 2554004; 2554004 (split product) Class III Blood products, possibly contaminated with bacteria, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Platelets Pheresis Leukocytes Reduced Irradiated 7755526 Class II Blood products, which were possibly contaminated with peptostreptococcus, were distributed. New York Blood Center, Inc.
Biologics Platelets Pheresis Leukocytes Reduced 7755526 Class II Blood products, which were possibly contaminated with peptostreptococcus, were distributed. New York Blood Center, Inc.
Biologics Platelets Pheresis Leukocytes Reduced 2563975 Class II Blood product, labels applied to blood unit or product with incorrect and/or missing information, was distributed. Community Blood Centers of South Florida, Inc.
Biologics Platelets Pheresis Leukocytes Reduced 2626417 Class II Blood products, possibly contaminated with bacteria, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Source Plasma 4270122230; 4270106949; 4270101308; 4270099113; 4270098694 Class III Blood products, collected from a donor, whose suitability to donate were not adequately determined, were distributed. Csl Plasma Inc
Biologics Source Plasma 4270111724; 4270109791; 4270108726; 4270107852 Class III Blood products, collected from a donor, whose suitability to donate were not adequately determined, were distributed. Csl Plasma Inc
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 2685957 Class II Blood product, labeled with incorrect or missing information, expiration date, was distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells Leukocytes Reduced 06LH04370 Class III Blood product, in which quality control did not meet specifications, was distributed. American National Red Cross (The)
Biologics Plasma Frozen within 24 hours (FP24) KL219351 Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. Providence Health System - Southern California
Biologics Source Plasma 08JMOH6315; 08JMOH5467 Class II Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed. BioLife Plasma Services LP
Biologics Source Plasma 0481168670; 0481164626; 0481162229; 0481151092; 0481149193; 0481147587; 0481142478; 0481135217; 0481133655 0481132172; 0481129937; 0481127849; 0481126845; 0481124261; 0481123369; 0481118863; 0481117754; 0481115886; 0481114916; 0481108353; 0481106858; 0481105016; 0481104035; 0481102241; 0481101556; 0481099665; 0481098882; 0481078512; 0481064959; 0481058585; 0481057630; 0481056877; 0481055904; 0481052197; 0481050378; Class II Blood products, collected from a donor whose routine physical examination was inadequately documented, were distributed. CSL Plasma Inc
Drugs Pure-Aid Allergy Relief, Diphenhydramine HCL Caplets, 25 mg, 20 caplets, Exclusively distributed by: Kareway Products Inc., Compton, CA --- UPC 8 56023 00158 2 Lot# 6781202 & 6781302 Class II Labeling: Not Elsewhere Classified; foil label on immediate blister pack indicates active ingredient as Chlorpheniramine rather than Diphenhydramine Kareway Product Inc
Biologics Source Plasma 09JMOC7038;09JMOC6415;09JMOC4184;09JMOC3299;09JMOB7889;09JMOB7058;09JMOB5778;09JMOB4515;09JMOB2187;09JMOA7431;09JMOA6680;09JMOA4269;09JMOA2844;09JMOA0654;08JMOK5375;08JMOK5119;08JMOK3680;09JMOC9312;08JMOK1687;08JMOK1133;08JMOJ9615;08JMOJ8551;08JMOJ5074;08JMOJ4145;08JMOJ2690;08JMOJ1794;08JMOJ0294;08JMOI9447;08JMOI8093;08JMOI7418;08JMOI5784;08JMOI4798;08JMOI3458;08JMOI2427;08JMOI1121;08JMOI0396;08JMOH8755;08JMOH7876;08JMOH6484;08JMOH5568 Class II Blood products, which were collected from a donor who had received a ear piercing within 12 months of the donation, were distributed. BioLife Plasma Services LP
Biologics Source Plasma 08MIDA5663, 08MIDA6675, 08MIDA6977, 08MIDA7108, 08MIDA7706, 08MIDA7941, 08MIDA8006, 08MIDA8391, 08MIDA8567, 08MIDA8822, 08MIDA9235, 08MIDA9269, 08MIDA9612, 08MIDA9796, 08MIDB0125, 08MIDB0231, 08MIDB0373, 08MIDB0613, 08MIDB1221, 08MIDB1409, 08MIDB1604, 08MIDB1606, 08MIDB1724, 08MIDB2310, 08MIDB2596, 08MIDB2702, 08MIDB3409, 08MIDB3773, 08MIDB4458, 08MIDB4459, 08MIDB4653, 08MIDB4821, 08MIDB5004, 08MIDB5426, 08MIDB5708, 08MIDB5764, 08MIDB6237, 08MIDB6472, 08MIDB6847, 08MIDB6996, 08MIDB7613, 08MIDB7999, 08MIDB8781, 08MIDB9151, 08MIDB9320, 08MIDB9800, 08MIDB9953, 08MIDB9978, 08MIDC0189, 08MIDC0332,  ...
More
Class II Blood products, collected from a donor who received tattoos within 12 months of donation, were distributed BioLife Plasma Services L.P.
Biologics Source Plasma 4200121733, 4200121009, 4200120541, 4200119892, 4200119445, 4200118401, 4200118072, 4200117188, 4200116950, 4200115891, 4200115583, 4200114690, 4200114409, 4200113424, 4200112815, 4200112247, 4200111781, 4200111182, 4200110583, 4200110061, 4200109379, 4200108583, 4200108356, 4200107097, 4200106713, 4200105612, 4200105244, 4200104240, 4200103792, 4200103001, 4200101666, 4200099990, 4200099607, 4200098799, 4200098502, 4200097683, 4200097454, 4200096654, 4200096265, 4200095655 Class II Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed. Talecris Plasma Resources
Drugs 0.9% Sodium Chloride Injection, USP, Polyolefin Flexible Container, a) 500 mL (NDC 0409-7983-30), b) 1000 mL (NDC 0409-7983-48), c) 250 mL (NDC 0409-7983-02), d) 150 mL (NDC 0409-7983-61), Rx Only, by Hospira, Inc., Lake Forest, IL 60045 Lot #: a) 89-135-JT, 04-224-JT, 07-138-JT, Exp 4/13, 08-160-JT Exp. 8/13 ; b) 08-163-JT, 90-036-JT, 02-048-JT, Exp 2/13; c) 93-102-JT, 11-063-JT, Exp 9/12; d) 93-096-JT, Exp 11/12 Class II Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags. Hospira Inc.
Drugs 70% Dextrose Injection USP, 2000 mL, Rx Only, by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7120-07 Lot #: 13-041-JT, Exp 1/14 Class II Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags. Hospira Inc.
Drugs 0.45% Sodium Chloride Injection, USP, Rx Only, 250 mL, by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7132-02 Lot #: 93-153-JT, Exp 9/12 Class II Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags. Hospira Inc.
Drugs 5% Dextrose Injection USP, a) 250 mL (NDC 0409-7922-02), b) 500 mL (NDC 0409-7922-30), by Hospira, Inc., Lake Forest, IL 60045 Lot #: a) 01-201-JT, Exp 7/12; b) Lot 91-054-JT, Exp 7/12 Class II Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags. Hospira Inc.
Drugs 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL VisIV Container, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7926-48 Lot #: 11-161-JT, Exp 11/13 Class II Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags. Hospira Inc.
Drugs 20% Dextrose Injection, USP, a) 500 mL in 1000 mL Partial-Fill Container (NDC 0409-7935-19), b) 500 mL VisIV Container (NDC 0409-7953-30), c) 1000 mL VisIV Container, (NDC 0409-7953-48), Rx Only, Hospira, Inc., Lake Forest, IL 60045 Lot #: a) 09-183-JT, Exp 3/13; b) 01-081-JT, Exp 7/12; c) 07-078-JT, 91-083-JT, Exp 7/12 Class II Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags. Hospira Inc.
Drugs 0.9% Sodium Chloride Irrigation, USP, 3000 mL, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7972-08 Lots #: 04-151-JT, 06-040-JT, Exp 4/13 Class II Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags. Hospira Inc.
Drugs 1.5% Glycine Irrigation, USP, 3000 mL, Rx Only, Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7974-08 Lot #: 95-057-JT, Exp 11/12 Class II Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags. Hospira Inc.
Drugs 0.9% Sodium Chloride Injection, USP, a) 50 mL (NDC 0409-7984-13), b) 50 mL (NDC 0409-7984-36), c) 100 mL (0409-7984-37), Rx Only, Hospira, Inc., Lake Forest, IL 60045 Lot #: a) 11-085-JT, Exp 11/13; b) 06-111-JT, Exp 12/12, c) 93-030-JT, 14-044-JT, Exp 9/12 Class II Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags. Hospira Inc.
Veterinary Boots & Barkley American Beef Bully Sticks, 6 count, UPC 647263899189, Distributed by Target Corporation Minneapolis, MN 55403, Target Brands, Inc. Made in the U.S.A. Promotes Plaque and Tartar Reduction; packaged in transparent flexible plastic with a folded paper label enclosed with staples. The label is white, red and blue with black, white, red, and blue print writing and a photograph of a black and white dog. Best By dates of 20APR2014 DEN to 03OCT2014 DEN. Class I Kasel Industries is recalling Boots & Barkley American Beef Bully Sticks, 6 count, due to possible contamination with salmonella bacteria. Kasel Associates Industries, Inc.
Veterinary Nature's Deli Chicken Jerky Dog Treats, 2.5 lbs. bag, UPC 647263800208, Best By "091913 DEN", Division of Kasel Industries, Denver, CO 80205. Packaged in a transparent, flexible, plastic bag; the bag is yellow with black and white print writing and a photograph of a golden retriever dog on it. Best By "09192013 DEN" Class I Kasel Associated Industries is voluntarily recalling a specific lot of Nature's Deli Chicken Jerky Dog Treats, 2.5 lbs. bag, due to possible contamination with Salmonella bacteria. Kasel Associates Industries, Inc.
Veterinary Boots & Barkley Roasted American Pig Ears, net wt 12 oz, 12 count, UPC 647263899158. Delicious Treat for Dogs, Made in the U.S.A. Distributed by TARGET Corporation, Minneapolis, MN 55403. Best By 13SEP2014DEN. Class I Kasel Associated Industries is voluntarily recalling a specific lot of Boots & Barkley Roasted American Pig Ears, due to possible contamination with Salmonella bacteria. Kasel Associates Industries, Inc.
Veterinary Boots & Barkley, American Variety Pack Real Beef & Pork Treats for Dogs, net wt 32 oz., UPC 490830400086; Product of U.S.A. Distributed by TARGET Corporation, Minneapolis, MN 55403, Packaging is white, blue and red with red, black and blue print writing. Best By 13SEP2014DEN. Class I Kasel Associated Industries is voluntarily recalling a specific lot of Boots and Barkley American Variety Pack, due to possible contamination with Salmonella bacteria. Kasel Associates Industries, Inc.
Devices Sarns " TCM II Temperature Control Module The Sarns" TCM II Temperature Control Module is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and is indicated for controlling and monitoring patient temperature Catalog Number 4416 and Serial Numbers: 4656, 4657, 4658,4659, 4661, 4662, and 4663. Class II Internal testing found certain Sarns" TCM II systems were released with incorrectly assembled heatsink assemblies which could cause the units to fail. Terumo Cardiovascular Systems Corporation
Veterinary Ivermectin/pyrantel flavored chewables for dogs up to 25 lbs., each tablet contains 68 mcg. ivermectin and 57 mg. pyrantel as pamoate salt, RX, ANADA 200-302, packaged with the following brand names and configurations: (1) Virbac Animal Health Iverhart Plus Flavored Chewables, packaged 6 tablets per box, 10 boxes per display, product #0170DS. Manufactured by: Virbac AH, Inc., Fort Worth, TX; (2) Wormshield Flavored Chewables Hannah Pharmaceuticals, packaged 6 tablets per box, 10 boxes per display, product #0210DS. Manufactured for: Schuyler LLC, Portland, OR; and (3)Virbac Animal Health Iverhart Plus Puppy Pac, promotional Information packet containing 1 tablet, product #01800. Manufactured by: Virbac AH, Inc., Fort Worth, TX; Iverhart Plus and Wormshield lots:120844 and 120196: Puppy Pac lot 120844 only Class III Firm testing found recalled lots to be out of specification with sub-potent results. Virbac Corporation
Veterinary Worm Shield (ivermectin/pyrantel) Flavored Chewables to prevent heartworm disease and to treat and control ascarid and hookworm infections in dogs. Hannah Pharmaceuticals Manufactured for Schuyler LLC Portland OR Product number 0210DS - lots:120844 and 120196 Class III Firm testing found recalled lots to be out of specification with sub-potent results. Virbac Corporation
Veterinary Worm Shield (ivermectin/pyrantel) Flavored Chewables to prevent heartworm disease and to treat and control ascarid and hookworm infections in dogs. Hannah Pharmaceuticals Manufactured for Schuyler LLC Portland OR Product number 0210DM - lots:120202 and 120845 Class III Firm testing found recalled lots to be out of specification with sub-potent results. Virbac Corporation
Veterinary Iverhart Plus (ivermectin/pyrantel) Flavored Chewables to prevent heartworm disease and control ascarid and hookworm infections in dog Product number 0170DM - lot 120202 Class III Firm testing found recalled lots to be out of specification with sub-potent results. Virbac Corporation
Veterinary Iverhart Plus (ivermectin/pyrantel) Flavored Chewables to prevent heartworm disease and control ascarid and hookworm infections in dog Product number 0170DL - lots:120856; 120076 and 120086 Class III Firm testing found recalled lots to be out of specification with sub-potent results. Virbac Corporation
Biologics Source Plasma 12MKEB3730 Class II Blood product, collected from a donor whose scheduled physical examination was incomplete, was distributed. Interstate Blood Bank, Inc. of Wisconsin
Devices The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially designed data program application (software), which is supplied for installation in existing mainframe or decentralized computers or a computer network. This software system will not be the software directly used to run, steer, or control any specific laboratory analyzer or equipment. It is intended for use in laboratory facilities, including a central laboratory or in a multiple laboratory environment servicing satellite laboratories, reference laboratories, clinics, etc. Centricity Laboratory System is not intended for direct patient contact. Software Versions 3.3, 4.0, and 4.1 Class II If environment variables MICRO_CORRECT_MSG_TYPE and CORRECT_MSG_TYPE are set to different values, in Microbiology result entry when released results (Final Report released) are changed and the Corrected Result messages are edited on the free-text form, some of the originally entered panel free-text is lost. For this issue to occur the original result must be amended and the environmental variables set to different values. GE Healthcare It
Biologics Red Blood Cells Leukocytes Reduced W069112100292; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Mississippi Blood Services Inc.
Biologics Blood and Blood Products for Reprocessing W069112100292; Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Mississippi Blood Services Inc.
Biologics Red Blood Cells Leukocytes Reduced W035811160557; W035811088380; W035810480891; W035810351796; W035809225308; W035808122086; W035808040583; LR55337; GG43148; LQ20765; LQ00760; LM40001; Class II Blood products, collected from a donor who was previously deferred for a positive HIV test result, were distributed. BloodSource, Inc.
Biologics Blood and Blood Products for Reprocessing W035809225308; W035811160557; W035811088380; W035810480891; W035810351796; W035808122086; W035808040583; LR55337; GG43148; LQ20765; LQ00760; LM40001; Class III Blood products, collected from a donor who was previously deferred for a positive HIV test result, were distributed. BloodSource, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W118813700191; W118813700191; Class II Blood products, collected from a donor who reported a post donation illness, were distributed. The Blood Alliance, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 1018764; 1125778; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. OneBlood / dba CBCF
Biologics Red Blood Cells Leukocytes Reduced W045112384837; Class II Blood products, collected from a donor who lived with a hepatitis positive individual, were distributed. Community Blood Center of the Ozarks
Biologics Cryoprecipitated AHF W045112384837; Class II Blood products, collected from a donor who lived with a hepatitis positive individual, were distributed. Community Blood Center of the Ozarks
Biologics Blood and Blood Products for Reprocessing W045112384837; Class II Blood products, collected from a donor who lived with a hepatitis positive individual, were distributed. Community Blood Center of the Ozarks
Biologics Red Blood Cells Leukocytes Reduced W227012054348; Class II Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed. Community Blood Center of Carolinas
Biologics Fresh Frozen Plasma W227012054348; Class II Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed. Community Blood Center of Carolinas
Biologics Cryoprecipitated AHF W045112351950; Class II Blood products, collected from a donor whose sexual partner had a history of hepatitis B, were distributed. Community Blood Center of the Ozarks
Biologics Red Blood Cells Leukocytes Reduced 6833181; 6840218; W045111238317; Class II Blood products, collected from a donor whose sexual partner had a history of hepatitis B, were distributed. Community Blood Center of the Ozarks
Biologics Red Blood Cells W045109951768; 6980871; 6882797; W045110161552; W045110143792; Class II Blood products, collected from a donor whose sexual partner had a history of hepatitis B, were distributed. Community Blood Center of the Ozarks
Biologics Blood and Blood Products for Reprocessing W045110143792; 6833181; W045109951768; 6980871; 6943518; 6882797; 6840218; W045112351950; W045111327405; W045111238317; W045110161552; Class II Blood products, collected from a donor whose sexual partner had a history of hepatitis B, were distributed. Community Blood Center of the Ozarks
Drugs 0.9% Sodium Chloride Injection, USP, 50 mL Mini-Bag Plus Container, Rx only, distributed by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0553-11 Lot: P293118; Exp Date: 10/13 Class II Labeling Wrong Barcode; It may display wrong product code reflecting 0.9% Sodium Chloride Injection , USP 100 mL in MINI-BAG Plus container instead of 50 mL. Baxter Healthcare Corp.
Biologics Cornea CW101074OD; CW101074OS Class III Human Corneas, recovered from a donor whose donor eligibility determination was incomplete related to evaluating the donor's clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. Eye Bank Of Wisconsin, Inc.
Biologics Blood Grouping Reagent, Anti-S (Monoclonal) 813607001; 820312001 Class III Seraclone Anti-S, with a decreased reactivity in two lots numbers, was distributed. Bio-Rad Medical Diagnostics GmbH
Devices Brilliance CT 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems. Produce cross-sectional images of the body by computer reconstruction of x-ray transmission. The following codes are affected by this recall:System Code #728231,  ...
More
Class II If the operator selects a patient name from the worklist using the mouse and then selects a different patient name using the keyboard (arrow keys then press enter) the patient name that populates the exam information page is the patient name selected with the mouse. Also, it is possible to begin a normal clinical scan while the anti-virus scan is running. However, if the user is running a bolus tracking scan, typical real time information is not displayed to the user. The consequence is the user may initiate the clinical scan either earlier or later than desired resulting in a mistimed bolus. And, if the operator is running a bolus tracking scan at the time the anti-virus is scheduled to run and the operator ignores or is not aware of the McAfee VirusScan Notification message displayed on the screen, typical real time information will not be displayed to the user. The consequence is the user may initiate the clinical scan either earlier or later than desired resulting in a mistimed bolus. Philips Medical Systems (Cleveland) Inc
Devices Quick Connect QLC1677E, QRC1699E, QPC1721E and QFC1683E. STERIS Corporation, Mentor, OH 44060 QLC1677E, QRC1699E, QPC1721E and QFC1683E contain processing instructions, a Quick Reference Wall Chart and a flow unit. The flow unit consists of a Quick Reference Card, tubing, tethers and adapters for connecting specified devices to Flexible Processing Trays/Containers. LOT NUMBERS: QLC1677E: 1986157 - 2740157; QRC1699E: 1953884- 3376282 & QPC1721E/ QFC1683E: 3809423-Q001121. Class II During a routine label review, the firm identified four SYSTEM 1E Quick Connects that will be updated to reflect the removal of obsolete device models. This labeling review process also highlighted the opportunity to combine two existing quick connects into a single product while eliminating the obsolete models. Steris Corporation
Biologics Red Blood Cells Leukocytes Reduced W036813020316; W036813020316 Class II Blood products, collected from an ineligible donor, were distributed. OneBlood / dba CBCF
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 1163414 Class II Blood products, collected from an ineligible donor, were distributed. OneBlood / dba CBCF
Biologics Fresh Frozen Plasma 1163414 Class II Blood products, collected from an ineligible donor, were distributed. OneBlood / dba CBCF
Biologics 4R1583 "CPD/ADSOL DBL Flex-Excel/Sample Diversion SYS/PL146/PL2209 500 mL" FM11J31036, FM11J10022 Class III Blood-Pack Units, with missing labeling on the satellite bags, were distributed. Fenwal Inc
Biologics 4R3307E CPD/DSOL DBL WB RS-2000 W/FENWAL Express System/Y-Sampling Site 500 mL PL146 FM12J04016 Class III Blood-Pack Units, with missing labeling on the satellite bags, were distributed. Fenwal Inc
Biologics 4R3325E CPD/ADSOL TPL WB RS-2000 W/FENWAL Express System/Sample Diversion SYS 500 mL PL146 FM11J28016, FM11L06018 Class III Blood-Pack Units, with missing labeling on the satellite bags, were distributed. Fenwal Inc
Biologics 4R3329E CPD/ADSOL DBL WB RS-2000 W/FENWAL Express System/Sample Diversion SYS 500 mL PL146 FM12C13011 Class III Blood-Pack Units, with missing labeling on the satellite bags, were distributed. Fenwal Inc
Biologics 4R3340E CPD/ADSOL TPL WB RZ-2000 W/FENWAL Express System/Y-Sampling Site 500 mL PL146 FM12L19044 Class III Blood-Pack Units, with missing labeling on the satellite bags, were distributed. Fenwal Inc
Food Hot Dog Buns 8 Count Earthgrains Baking companies, Inc. Horsham, PA 19044 Best By Date 5 - 21 Class II Due to the possible presence of metal fragments caused by a faulty manufacturing part at a North Carolina bakery BIMBO Bakeries USA
Food Colonial Cookout Enriched Buns - 12 count Earthgrains Baking companies, Inc. Horsham, PA 19044 Best By Date 5 - 20 Class II Due to the possible presence of metal fragments caused by a faulty manufacturing part at a North Carolina bakery BIMBO Bakeries USA
Food Colonial Party Pack Enriched Buns - 12 count Sara Lee, Downers Grove, IL 60515 Best By Date 5 - 20 Class II Due to the possible presence of metal fragments caused by a faulty manufacturing part at a North Carolina bakery BIMBO Bakeries USA
Food Colonial Party Pack Sesame Seed Enriched Buns - 12 count Sara Lee, Downers Grove, IL 60515 Best By Date 5 - 20 Class II Due to the possible presence of metal fragments caused by a faulty manufacturing part at a North Carolina bakery BIMBO Bakeries USA
Food Colonial 12 Seeded Enriched Buns Sara Lee, Downers, Grove, IL 60515 Best By Date 5 - 21 Class II Due to the possible presence of metal fragments caused by a faulty manufacturing part at a North Carolina bakery BIMBO Bakeries USA
Food Great Value 8 Jumbo Hamburger Buns Distributed By: Wal-Mart Stores, inc., Bentonville, AR 72716 Best By Date 5 - 21 Class II Due to the possible presence of metal fragments caused by a faulty manufacturing part at a North Carolina bakery BIMBO Bakeries USA
Food Kerns Beef Buns - 12 count Distributed By: K-VA-T Food Stores, Inc., Arbingdon, VA 24210 Best By Date 5 - 20 Class II Due to the possible presence of metal fragments caused by a faulty manufacturing part at a North Carolina bakery BIMBO Bakeries USA
Food Kroger White Jumbo Hamburger Buns - 8 Buns Distributed By: The Kroger Co. Cincinnati, Ohio 45202 Best By Date 5 - 21 Class II Due to the possible presence of metal fragments caused by a faulty manufacturing part at a North Carolina bakery BIMBO Bakeries USA
Food Kroger Sandwich Enriched Buns - 12 count Distributed By: The Kroger Co., Cincinnati, Ohio 45202 Best By Date 5 - 20 Class II Due to the possible presence of metal fragments caused by a faulty manufacturing part at a North Carolina bakery BIMBO Bakeries USA
Food Sara Lee Hearty & Delicious 100% Whole Wheat 8 Bakery Buns Sara lee, Downers Grove, IL 60515 Best By Date 5 - 21 Class II Due to the possible presence of metal fragments caused by a faulty manufacturing part at a North Carolina bakery BIMBO Bakeries USA
Food Sara Lee Classic White 12 Hamburger Buns Sara Lee, Downers Grove, IL 60515 Best By Date 5 - 20 Class II Due to the possible presence of metal fragments caused by a faulty manufacturing part at a North Carolina bakery BIMBO Bakeries USA
Food 8 Bakery Buns Sara Lee Hearty & Delicious Sesame Seed and Sara Lee Gourmet Sesame Seed Hamburger Buns Restaurant Style - 12 count Sara Lee, Downers Grove, IL 60515 Best By Date 5 - 21 Class II Due to the possible presence of metal fragments caused by a faulty manufacturing part at a North Carolina bakery BIMBO Bakeries USA
Food 8 Bakery Buns Sara Lee Hearty & Delicious White Sara Lee, Downers Grove, IL 60515 Best By Date 5 - 21 Class II Due to the possible presence of metal fragments caused by a faulty manufacturing part at a North Carolina bakery BIMBO Bakeries USA
Food Sunbeam 12 Enriched Hamburger Buns and Sunbeam 12 (Seeded) Hamburger Buns Earthgrains Baking companies, Inc. Horsham, PA 19044 Best By Date 5 - 20 Class II Due to the possible presence of metal fragments caused by a faulty manufacturing part at a North Carolina bakery BIMBO Bakeries USA
Food Foodservice 100% Whole Wheat Hamburger Buns - 12 Ct Earthgrains Baking companies, Inc. Horsham, PA 19044 Best By Date 5 - 21 Class II Due to the possible presence of metal fragments caused by a faulty manufacturing part at a North Carolina bakery BIMBO Bakeries USA
Food Food Service Hamburger Buns Wheat with Oat 12 CT Earthgrains Baking companies, Inc. Horsham, PA 19044 Best By Date 5 - 21 Class II Due to the possible presence of metal fragments caused by a faulty manufacturing part at a North Carolina bakery BIMBO Bakeries USA
Food Foodservice Hamburger Buns - 12 Count Earthgrains Baking companies, Inc. Horsham, PA 19044 Best By Date 5 - 20 Class II Due to the possible presence of metal fragments caused by a faulty manufacturing part at a North Carolina bakery BIMBO Bakeries USA
Food Foodservice Hamburger Buns - 20 Count Earthgrains Baking companies, Inc. Horsham, PA 19044 Best By Date 5 - 21 Class II Due to the possible presence of metal fragments caused by a faulty manufacturing part at a North Carolina bakery BIMBO Bakeries USA
Food Hamburger Buns Bimbo Bakeries USA 255 Business Center Dr. Horsham, PA 19044 Food Service Hamburger Buns, Seeded and Unseeded, all counts: Best By Date 5 - 20 Class II Due to the possible presence of metal fragments caused by a faulty manufacturing part at a North Carolina bakery BIMBO Bakeries USA
Food Seeded Hamburger Buns Bulk Best By Date 5 - 20 Class II Due to the possible presence of metal fragments caused by a faulty manufacturing part at a North Carolina bakery BIMBO Bakeries USA
Devices Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Product is manufactured and distributed by Microgenics Corporation, Fremont, CA MAS Bilirubin is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Includes Bilirubin with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument. Catalog Number: 10014432; Lot Numbers: 1MQ310, Expiration Date: 31 Dec 2013, 2CQ310, Expiration Date: 31 Mar 2014, 2KQ310, Expiration Date: 31 Oct 2014 Class II It has been confirmed from in-house testing that Direct Bilirubin (DBIL), and Total Bilirubin (TBIL) claimed in Thermo Scientific MAS Bilirubin Systems are displaying reduced stability. Microgenics Corporation
Devices Prism Medical C-Series Carry Bar, Class I, model number 360755. The intended use is a carry bar attached to a C-450 or C-625 ceiling lift used to lift, transfer or position clients. model number 360755 Class II The firm replaced the recalled carry bar with a plastic insert with a carry bar with a metal insert due to improper installation of the recalled carry bars. Prism Medical Services USA
Devices BD SafetyGlide Allergy. REF 305950 Sterile Allergy Treatment Syringe Tray. The device is used for aspiration and injection of medications. Catalog/Lot Number: REF#305950 Lot 2132028 and Lot 2159189 Class II There has been an increase in complaints regarding the needle/safety mechanism disengaging from the syringe. Becton Dickinson & Company
Devices CoaguChek XS System (PST) The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin® or warfarin. Model/Catalog/Part Number: 04837738001 Class II Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS, CoaguChek XS Plus, and CoaguChek XS Pro meters. In rare cases, instead of a value, an ERROR 6 message is displayed. Roche Diagnostics Operations, Inc.
Devices CoaguChek XS Pro System The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoaguChek XS PT Test strips) quantitatively determines prothrombin time ("PT"), using capillary blood or whole blood from a vein (non anticoagulated venous whole blood). Model/Catalog/Part Number: 05530199160 Class II Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS, CoaguChek XS Plus, and CoaguChek XS Pro meters. In rare cases, instead of a value, an ERROR 6 message is displayed. Roche Diagnostics Operations, Inc.
Devices CoaguChek XS Plus System The CoaguChek XS Plus system for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. Model/Catalog/Part Number: 05021537001 Class II Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS, CoaguChek XS Plus, and CoaguChek XS Pro meters. In rare cases, instead of a value, an ERROR 6 message is displayed. Roche Diagnostics Operations, Inc.
Devices CoaguChek XS System (HCP) The CoaguChek XS System is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. Model/Catalog/Part Number: 04837975001 and 04625412160 Class II Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS, CoaguChek XS Plus, and CoaguChek XS Pro meters. In rare cases, instead of a value, an ERROR 6 message is displayed. Roche Diagnostics Operations, Inc.
Devices VITROS Chemistry Products K+ (Potassium) Slides (Reagent), REF/Catalog Number 815 7596, Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products K+ Slides quantitatively measure potassium (K+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. GEN 4102, Coating 0884, Lot XXXX (exp. 06/01/2014) and GEN 4102, Coating 0885, Lot XXXX (exp. 06/01/2014 and 07/01/2014). The term GEN and Coating refer to specific segments of the reagent lot number. Class III While performing interval testing, Ortho Clinical Diagnostics (OCD) determined that a surfactant was unintentionally added to VITROS Chemistry Products K+ Slides during the manufacturing process. Ortho-Clinical Diagnostics
Devices VITROS Chemistry Products CRP Slides (Reagent), REF/Catalog Number 192 6740 and 809 7990, Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products CRP Slides quantitatively measure C-reactive protein (CRP) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. GEN 3773, Coating 0766, Lot XXXX (exp. 11/01/2013); GEN 3784, Coating 0767, Lot XXXX (exp. 11/01/2013); and GEN 3785, Coating 0768, Lot XXXX (exp. 10/01/2013 and 11/01/2013). The term GEN and Coating refer to specific segments of the reagent lot number. Class III While performing interval testing Ortho Clinical Diagnostics (OCD) determined that an excess amount of surfactant was unintentionally added to VITROS Chemistry Products CRP Slides during the manufacturing process. Ortho-Clinical Diagnostics
Devices Baxter, MiniCap with Povidone-Iodine solution, 5C4466P, Baxter Healthcare Corporation, Deerfield, IL 30015 USA. Intended to isolate the Easy-Lock connector of the solution transfer set. Lot Number GD893891 Class II leaking pouches Baxter Healthcare Corp.
Food FLAV-R-PAC IQF Chopped Spinach, packaged in a 32 oz. bag, NORPAC Catalog #30238-01. The UPC is 0 48800 30238 2 The product is labeled in parts: "***FLAV R PAC***Classic Vegetables***Chopped Spinach***INGREDIENTS: Spinach***NET WT 32 OZ (2 LB)***PRODUCT OF USA***Keep frozen until ready to use***Distributed by Norpac Foods Inc 4350 S.W. Galewood St. Lake Oswego, OR 97035-2499***www.norpac.com***". BEST BY FEB 2015/ 5F3 1248 19 HH:MM. The code is interpreted as: 5F3 1248 19 HH:MM- Packed into Poly Bags on February 12, 2013 7:00am to 9:30am at NORPAC Foods Inc. Repack Plant #8 2210 Madrona Ave S.E. Salem. Oregon 97302-1112. 5 = Pkr; F = February: 3 = 2013; 12 =  ...
More
Class II IQF frozen chopped Spinach is recalled due to detection of elevated level of Cadmium. Norpac Foods, Inc.
Veterinary SOGEVAL VETRICALM Soft Chews for Dogs Contact Sogeval Laboratories, Inc., Oldsmar, FL Lot #008871 (60 count), expiration date 11/2013 Lot #008881 (120 count), expiration date 11/2013 Class II Product's recent testing microbial analysis revealed results exceeding that of the upper limit of normal bacterial specifications. Sogeval Laboratories Inc
Drugs INK-EEZE Tattoo Numbing Spray, 2 oz. (59 mL), Active Ingredients: Lidocaine HCl 5% Topical Anesthetic, Distributed by: Indelicare, LLC 914 Tourmaline Drive, Newbury Park, CA 91320, (800) 611-7720, www.inkeeze.com Lot L0207 Class II Marketed without an approved NDA/ANDA: INK-EEZE Tattoo Numbing Spray contains 5% Lidocaine and is being marketed without an approved NDA/ANDA. Lidocaine 5% is an ingredient in many FDA approved products, making Ink-Eeze an unapproved new drug. Indelicare LLC
Drugs INK-EEZE Tattoo Black Label Numbing Spray, a) 0.27 oz. (8 mL), b) 2 oz. (59 mL), No Epinephrine, Active Ingredients: Lidocaine HCl 5% Topical Anesthetic, Distributed by: Indelicare, LLC 914 Tourmaline Drive, Newbury Park, CA 91320, (800) 611-7720, www.inkeeze.com. Lot #: L0211 Class II Marketed without an approved NDA/ANDA: INK-EEZE Tattoo Numbing Spray contains 5% Lidocaine and is being marketed without an approved NDA/ANDA. Lidocaine 5% is an ingredient in many FDA approved products, making Ink-Eeze an unapproved new drug. Indelicare LLC
Food Enzyme Solutions, A Dietary Supplement, Formula 29, 8 oz. (226.8g), UPC Code 697706041408. Distributed by: Enzyme Formulations, Inc., Madison, Wisconsin, 53719. Lot 1225822 Class II Enzymes Formulations Inc. is recalling Enzyme Solutions Formula 29 8 oz., lot 1225822 because of a labeling error at the manufacturing. This resulted in 10 jars incorrectly containing a Multiple Enzyme Powder. Enzyme Formulations, Inc.
Devices INFUSE(R) Bone Graft, SMALL KIT, REF 7510200, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic Lots: M111057AAP, M111064AAD, M111064AAC, M111063AAJ, M111064AAK, M111064AAL, M111064AAV, M111064AAM, M111064AAW, M111064AAG, M111057AAM, M111063AAD, M111064AAQ, M111064AAO, M111064AAP, M111063AAP, M111064AAB, M111063AAC, M111064AAY, M111057AAD, M111057AAE Class II Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation. Medtronic Sofamor Danek USA Inc
Devices INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic Lots: M111063AAA, M111063AAB, M111064AAI, M111064AAF, M111064AAE, 111064AAT, M111064AAU, M111064AAX, M111064AAJ, M111064AAR, M111064AAS Class II Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation. Medtronic Sofamor Danek USA Inc
Devices INFUSE(R) Bone Graft, LARGE KIT, REF 7510600, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic Lots: M111052AAE, M111052AAN, M111052AAS, M111052AAD, M111059AAA Class II Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation. Medtronic Sofamor Danek USA Inc
Devices INFUSE(R) Bone Graft,LARGE II KIT, REF 7510800, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic Lots: M111103AAG, M111052AAQ, M111052AAR, M111052AAP, M111052AAL, M111059AAC, M111059AAF, M111052AAF, M111059AAH, M111103AAB, M111059AAG, M111052AAK, M111052AAJ, M111059AAB, M111059AAK, M111052AAI, M111052AAO, M111052AAH, M111052AAG, M111059AAD Class II Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation. Medtronic Sofamor Danek USA Inc
Devices INFUSE(R) Bone Graft, SMALL KIT, REF 7510200AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic Lots: M111063AAK, M111064AAH, M111063AAE, M111063AAO Class II Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation. Medtronic Sofamor Danek USA Inc
Devices INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic Lots: M111063AAF, M111064AAN Class II Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation. Medtronic Sofamor Danek USA Inc
Devices INFUSE(R) Bone Graft, LARGE II KIT, REF 7510800AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic Lots: M111103AAC, M111052AAT, M111059AAE, M111054AAR, M111052AAM Class II Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation. Medtronic Sofamor Danek USA Inc
Devices Medtronic Sutureless Pump Connector Revision Kit, model 8578. Contents: catheter interface with attached sutureless pump connector, catheter, connector pin, and strain-relief sleeve to be used with Medtronic SynchroMed implantable drug infusion pumps. Contents of inner package are STERILE. The Medtronic Model 8578 Sutureless Pump Connector Revision Kit is used when a pump connector for an Indura 1P Model 8709 or Model 8709SC catheter is required. The catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and an Indura 1P Model 8709 or Model 8709SC catheter. The catheter connects to the pump with the Model 8578 sutureless pump connector at the catheter port. Product having a Use By Date prior to 25 Aug 2014 Class I The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion at the catheter to pump interface. Medtronic is removing the unused products from the market that were manufactured with the previous design, and recommend the previous design no longer be used due to greater potential for misalignment and subsequent occlusion. Medtronic Neuromodulation
Devices Medtronic Intrathecal Catheter Pump Segment Revision Kit, model 8596SC. Contents: 60-cm pump segment with attached sutureless pump connector, Spinal Segment Strain-relief sleeves, Pump segment strain-relief sleeves, Connector pin. Contents of inner package are STERILE. The Medtronic Model 8596SC Pump Segment Revision Kit is used when a revision to the pump segment of the Model 8731 or Model 8731SC catheter is required. The catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and a Model 8731 or Model 8731SC catheter. The catheter connects to the pump at the catheter port. Product having a Use By Date prior to 25 Aug 2014 Class I The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion at the catheter to pump interface. Medtronic is removing the unused products from the market that were manufactured with the previous design, and recommend the previous design no longer be used due to greater potential for misalignment and subsequent occlusion. Medtronic Neuromodulation
Devices Medtronic INDURA 1P Intrathecal Catheter, model 8709SC. Contents: 81.4-cm catheter with length markers and guide wire, 15 T-gauge introducer needle, Sutureless pump connector with attached 7.6-cm catheter and Connector pin, Transparent Strain-relief sleeves, and anchors. Contents of inner package are STERILE. The implantable Medtronic INDURA 1P Model 8709SC Intrathecal Catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and a Model 8709SC catheter. The catheter connects to the pump at the catheter port. Product having a Use By Date prior to 25 Aug 2014 Class I The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion at the catheter to pump interface. Medtronic is removing the unused products from the market that were manufactured with the previous design, and recommend the previous design no longer be used due to greater potential for misalignment and subsequent occlusion. Medtronic Neuromodulation
Devices Medtronic Intrathecal Catheter, model 8731SC. Contents: 38.1-cm spinal segment with length markings and guide wire, 66-cm pump segment, 15 T-gauge introducer needle, Transparent Strain-relief sleeves, Opaque Strain-relief sleeves, and V-wing anchors. Contents of inner package are STERILE. The implantable Medtronic Model 8731SC Intrathecal Catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and a Model 8731SC catheter. The catheter connects to the pump at the catheter port. Product having a Use By Date prior to 25 Aug 2014 Class I The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion at the catheter to pump interface. Medtronic is removing the unused products from the market that were manufactured with the previous design, and recommend the previous design no longer be used due to greater potential for misalignment and subsequent occlusion. Medtronic Neuromodulation
Devices TRUE Dilatation Balloon Valvuloplasty Catheter, REF Numbers: 02045-11, 02245-12, 02445-12, and 02645-13; Sizes: 20mm x 4.5cm, 22mm x 4.5cm, 24mm x 4.5cm, and 26mm x 4.5cm; Intended to be used for balloon aortic valvuloplasty. All lot numbers lower than PLN00749 are subject to this recall. Class II Slow deflation time: Slower than normal balloon deflation time of greater than 10 seconds. The balloon normally deflates in less than 5 seconds. The device performance specification for deflation time is 10 seconds maximum. Loma Vista Medical
Devices Code Alert Advanced 4-Way Care Solution, CA520 System, PN 9600-1600, RF Technologies. This product is used to alert caregivers when a patient at risk for falls is leaving a bed or chair. all codes Class II RF Technologies, Inc. has initiated a recall involving CA520 Code Alert Integrated Care Management Advanced 4-Way Care Solution . Due to a firmware error, the alarm may not be transmitted to the system server immediately. RF Technologies, Inc.
Devices CMC Saddle Product Usage: The Ascension CMC is intended to resurface the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteo-arthritis, or post-fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion. This is an uncemented prosthesis designed for press fit use only. Lot/Serial Number: 111602, 110864, 102815, 091515, 092563, 110863. Product/Catalogue No: CMC-410-10, CMC-410-20, CMC-410-30, CMC-410-40. Class III As a result of a quality review, labelling content discrepancies were identified between the Instruction for Use (IFU) distributed in the US with the Ascension CMC and the content that is cleared by FDA. Integra LifeSciences Corp.
Devices Brand Name: Coiled Tube Infusors (Portable Elastomeric Infusion Systems). Baxter's Infusor SV Elastomeric Infusion Device Device Listing: D020871 Baxter's lnfusors SV Elastomeric Infusion Device is a single-use, disposable elastomeric infusion pump indicated tor patients requiring slow, continuous intravenous, intra-arterial, subcutaneous, or epidural administration of medications at a constant flow rate. Product Code: 2C1073KJP Lot Numbers: 08M002, 08N007, 08N029, 08N030, 08N034, 08N069, 08N070, 09A001 Class II Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in complaints for leaks at the distal male Luer and Luer cap. Baxter implemented enhancements to the blue winged cap to improve the seal between the cap and the Luer. Complaint rates for leaks have since decreased. Baxter wants to ensure that no affected product remains in the field. Baxter Healthcare Corp.
Devices Brand Name: Coiled Tube Infusors. Multiday lnfusor, Seven Day lnfusor and the Basal/Bolus lnfusor: Single day Infusor 2 ml/h, Single Day INFUSOR 2 ml/h System, Half Day INFUSOR SV 5 ml/h System, Two Day INFUSOR 2 ml/h System, Two day Infusor 2 ml/h, Two Day INFUSOR 2ml/h System, Multiday Infusor 0.5 ml/h, Multiday INFUSOR 0.5ml/h System, Seven Day Infusor 0.5 ml/h, Seven Day INFUSOR 0.5ml/h System, Basal-Bols Infusor-15min., Basal/Bolus INFUSOR 0.5 x 2 ml/h System with 15 Minute Lockout, Basal-Bolus Infusor Device Listing: D018045 The Multiday lnfusor. Seven Day lnfusor and the BasaVBolus lnfusor are indicated for patients requiring slow, continuous intravenous, intra-arterial, subcutaneous or epidural administration of medications. Product Codes: 2C1071KJP, 2C1073KJP, 2C1075KJP, 2C1080KJP, 2C1082KJP, 2C1955KJP, 2C1976KJ. Expiration Dates: 06/30/13, 12/31/13, 06/30/14, 12/31/14 Class II Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in complaints for leaks at the distal male Luer and Luer cap. Baxter implemented enhancements to the blue winged cap to improve the seal between the cap and the Luer. Complaint rates for leaks have since decreased. Baxter wants to ensure that no affected product remains in the field. Baxter Healthcare Corp.
Devices Brand Name: Infusor SV and LV Elastomeric Infusion Devices. Indicated for the intravenous administration of medications. Product Codes: 2C1008KP, 2C1009KP, 2C1063KP, 2C1087KP, 2C1156KP, 2C1700KP, 2C1702KP Lot Codes: 10F032 10G056 10H066 10J047 10K024 10K087 10M021 10M088 10F059 10F069 10F070 10G029 10G043 10G062 10G067 10H032 10H093 10J049 10J060 10J089 10J105 10K028 10K030 10K038 10K088 10K096 10K102 10M025 10M044 10F022 10F068 10F072 10G030 10G045 10G046 10G047 10G050 10G051 10H016 10H018 10H087 10H094 10J053 10J058 10J062 10J102 10K026 10K035 10K039 10K086 10M023 10M040 10M043 10M045 10F020 10F087 10H086 10H095 10J017 10J020 10J056 10J068 10K021 10K029 10K031 10K081 10K105 10M017 10M039 10J052 10K098 10F064 10H044 10K022 10K042 10F024 10F025 10F033 10F055 10F062 10F063 10F065 10H005 10H030 10H042 10J015 10J019 10J061 10J065 10K032 10K037 10K095 10M030 10M087 10M098 10M099 10M100 Expiration Date: 06/30/13 Class II Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field. Baxter Healthcare Corporation
Devices Brand Name: Multirate Infusor Devices. Indicated for the intravenous administration of medications. Product Codes: 2C1154KP, 2C1155KP, 2C9960KP, 2C9961KP Lot Numbers: 10F030 10F066 10H043 10H104 10K027 10K099 10M090 10G028 10J059 10M019 10M089 10F058 10G069 10G042 10J048 10M026 Expiration Date: 06/30/13 Class II Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field. Baxter Healthcare Corporation
Devices Brand Name: Regional Analgesia Infusor System with Patient Control. Indicated for the intravenous administration of medications. Product Codes: 2C1154KP, 2C1155KP, 2C9960KP, 2C9961KP Lot Numbers: 10F030 10F066 10H043 10H104 10K027 10K099 10M090 10G028 10J059 10M019 10M089 10F058 10G069 10G042 10J048 10M026 Expiration Date: 06/30/13 Class II Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field. Baxter Healthcare Corporation
Devices Brand Name: Intermate Infusion Pump. Indicated for the intravenous administration of medications. Product Codes: 2C1064K Lot Codes: 10F007 10F077 10H075 10J097 10K076 10K112 10M062 Expiration Date: 06/30/13 Class II Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field. Baxter Healthcare Corporation
Devices Brand Name: Intermate Infusion Pump. Indicated for the intravenous administration of medications. Product Codes: 2C1730K, 2C1732K, 2C1734K, 2C1740K, 2C1743K, 2C1744K Lot Codes: 10F009 10F049 10F053 10F057 10F095 10J006 10J079 10K077 10M067 10F004 10F015 10G016 10G017 10G018 10G019 10G053 10G054 10H007 10H008 10H009 10H049 10H050 10H051 10H079 10H080 10H081 10H108 10J002 10J009 10J011 10J012 10J077 10J078 10J083 10K009 10K010 10K011 10K012 10K014 10K018 10K070 10K071 10K072 10M015 10M061 10M066 10M071 10M073 10M074 10M082 10F010 10F011 10F079 10G021 10G022 10G023 10H010 10H025 10H026 10H047 10J003 10J004 10J005 10J080 10J081 10J082 10J093 10K016 10K017 10K019 10M008 10M010 10M075 10M078 10M080 10M081 10H083 10M065 10F051 10F073 10G039 10G040 10J007 10J008 10J109 10K007 10K057 10K106 10M064 10M070 10F005 10F006 10F052 6/19/2010 6/22/2010 6/23/2010 8/13/2010 8/23/2010 8/30/2010 9/3/2010 9/30/2010 10/4/2010 10/21/2010 10/26/2010 11/4/2010 11/15/2010 11/24/2010 Expiration Date: 06/30/13 Class II Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field. Baxter Healthcare Corporation
Devices Brand Name: SV Elastomeric Infusion Device. Indicated for the intravenous administration of medications. Product Codes: 2C1071KJP, 2C1073KJP, 2C1075KJP Lot Codes: 08J078 08K002 08K005 08K007 08K054 08K066 08M001 08M025 08M028 08M039 08N003 08N005 08N032 09A004 09A040 09A042 09A064 98025 98027 98028 98070 09(018 09C023 09(024 09C045 09C047 09(075 90029 90031 90033 90065 90069 90086 09E026 09E027 09E031 09F023 09F024 09F025 09F040 09F041 09F042 09G013 09G061 09G062 09H004 09H008 09H035 09H036 09H070 09H082 09J006 09J007 09J074 09J075 09K017 09K018 09K021 09K022 09K086 09K087 09M002 09M005 09M037 09M038 09M039 09M078 09N027 09N028 09N029 09N034 10A019 10A020 10A021 10A044 108010 108029 10C002 10C003 10C006 10C078 10C079 10C099 10C103 10C111 100026 100027 100028 100058 100062 100063 10E003 10E008 10E009 10E067 10G005 10G006 10G007 10G008 10G078 10G079 10H014 10H019 10H020 10H022 10H054 10H056 10H057 10H060 10H069 10H071 10H105 10H107 10J022 10J023 10J026 10J028 10J029 10J070 10J071 10J074 10K043 10K044 10K047 10K049 10K051 10K061 10K065 10K110 10M056 10M058 10M059 10M060 10N006 10N024 10N028 10N078 11A022 11A024 11A030 11A052 11A074 11A075 08K001 08K003 08K053 08K077 08M002 08N007 08N029 08N030 08N034 08N069 08N070 09A001 09A063 98026 98069 98071 09C046 90025 90032 90070 09E030 09F022 09F026 09G010 09H005 09H037 09J005 09J042 09J043 09J044 09J045 09J089 09K020 09K050 09M001 09M041 09N032 09N041 10A017 10A022 10A046 108014 108024 10C076 10C100 10C102 100025 100029 10E002 10E007 10E045 10E055 10G001 10G003 10G004 10H024 10H058 10H059 10H072 10J021 10J024 10J027 10J072 10K046 10K048 10K063 10K064 10M034 10M057 10N023 10N077 11A023 11A031 11A054 08K067 08M003 09A006 98078 90026 90085 09E052 09H001 09J071 09K053 09M003 09M077 108025 10C005 10C080 10C101 100059 10E053 10H023 10H106 10J030 10J045 10J069 10K066 10M086 10N027 11A025 Expiration Dates: 06/30/13, 12/31/13, 12/31/14, 06/30/14, 12/31/14, 06/30/15,12/31/15, 06/30/15 Class II Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field. Baxter Healthcare Corporation
Devices Brand Name: Basal/Bolus Infusor. Indicated for the intravenous administration of medications. Product Codes: 2C1955KJP, 2C1976KJ Lot Codes: 08K006 08M038 08N001 09C021 09E028 09F078 09H080 09J046 09M052 09N030 09N048 10A043 108023 10E054 10H055 10J031 10K050 10M085 10N026 09H033 10B028 10B081 10E004 10J106 Expiration Dates: 06/30/15, 12/31/14, 12/31/15, 06/30/14, 12/31/14 Class II Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field. Baxter Healthcare Corporation
Devices Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to mammography for breast cancer screening. Serial numbers: H1280099, H1180094, B1380105 Class II Devices labeled for an intended use not included in the existing 510(k) or PMA, in that, the user manual contains the Indication for Use of the soma v Platinum ABUS [a 510(k) product]. U-systems Inc
Devices GE Healthcare Senographe Essential System. The Senographe 2000D system generates digital mamnmographic images that can be used for screening and in the diagnosis of breast cancer. The Senographe 2000D is intended to be used in the same clinical applications as traditional film-based mamnmographic systems. Models 5144816-10 rev 2, 3 or 6 and 5144816-10-LE rev1. Class II GE Healthcare has recently become aware of a potential issue due to inaccessible Operator Instructions associated with the defective Operator Manual CD of the Senographe Essential. GE Healthcare, LLC
Devices Synchron System(s) Lactate Reagent Product Usage: Lactate (LACT) reagent, when used in conjunction with Synchron LX® System(s), UniCel® DxC 600/800 System(s) and Synchron® Systems Multi Calibrator, is intended for the quantitative determination of lactate concentration in human plasma and cerebrospinal fluid (CSF). Part Number A95550, Lot Number M210077 Class II Beckman Coulter has confirmed customer reports of LACT Lot M210077 failing calibration with error condition OCR LOW. The calibration failures appear to be related to improper shipping or storage conditions (frozen reagent). Failed calibration of LACT may cause a delay in reporting results. Beckman Coulter Inc.
Devices CARESCAPE Monitor B850 Product Usage: The CARESCAPE TM Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility on adult, pediatric, and neonatal patients and on one patient at a time. The system is indicated for monitoring of Hemodynamics, Airway Gases (Fi/Et CO2, O2, N2) and Anesthetic Agent), Spirometry, Gas Exchange (O2 Consumption (VO2), CO2 production (VCO2), energy expenditure (EE), and respiratory quotient (RQ)) and neurophysiological (including electroencephalography (EEG), Entropy, Bispectral Index (BIS) and Neuromuscular Transmission (NMT) Monitoring) status. It is a stand-alone monitor or interfaced to other devices. is designed to provide configuration and troubleshooting capabilities to qualified service personnel. The CARESCAPE Monitor B850 is not intended for use during MRI. Mfg Lot or Serial # SED11107648GA SED11107652GA SED11117927GA SED11117959GA SED11168563GA SED10293123GA SED10293124GA SED10353742GA SED10353743GA SED10132473GA SED10303335GA SED10333640GA SED11178619GA SED10142532GA SED10485114GA SED09340621GA SED09340629GA SED09340640GA SED09340654GA SED09340655GA SED09471473GA SED10021715GA SED10021720GA SED10041824GA SED10112150GA SED10112155GA SED10112156GA SED10112165GA SED10112173GA SED10112199GA SED10122287GA SED10122288GA SED10122291GA SED10122297GA SED10122314GA SED10122331GA SED10122332GA SED10122334GA SED10122335GA SED09090248GP SED09130299GP SED09130301GP SED09130304GP SED09130308GP SED09130309GP  ...
More
Class II GE Healthcare become aware of 4 potential issues associated with the CARESCAPE Monitor B850. These issues include CARESCAPE Monitor B850 uDOM failure, CARESCAPE Monitor B850 unstable USB communication, CARESCAPE Monitor B850 remote printing issue with currently printing PRN 50 recorder and CARESCAPE Monitor B850 reboots due to an X server freeze. GE Healthcare, LLC
Devices Pinnacle® Destination® Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Valve. Acts as a conduit to facilitate the introduction of interventional and diagnostic devices into the human vasculature. Lot MM27 Class II Medical devices were incorrectly labeled with extended expiration dates. Terumo Medical Corporation
Devices Terumo Glidesheath (tm), 6 French, Nitinol wire, product code 15-1060. Used to facilitate placing a catheter through the skin into a vein or artery. Lot MP08 Class II Medical devices were incorrectly labeled with extended expiration dates. Terumo Medical Corporation
Devices Multilite Dye Handpieces, an optional accessory of the RevLite SI Laser. The Revlite SI laser is intended for General Dermatology, Dermatologic and General Surgical Procedures. Which includes treatments such as tattoo removal, pigmented lesion removal, removal or lightening of hair, skin resurfacing and reduction of red pigmentation in hypertropic and keloid scars The two Multilite Dye Handpieces (HPs) are optional handpieces that can be used with the Revlite SI Laser. Manufactured by: ConBio, A Cynosure Company 47733 Fremont blvd Fremont, CA 94538 659-1050-585 nm Handpiece; Manufacturer numbers: 659-1050 / C13B1141 659-1050 / D13C1151 659-1050 / D13C1157 659-1050 / D13C1158 659-1050 / D13C1160 659-1050 / D13C1154 Model 659-1100 - 650 nm Handpiece; manufacturer numbers: 659-1100 / C13B1141 659-1100 / D13C1151 659-1100 / D13C1157 659-1100 / D13C1158 659-1100 / D13C1160 659-1100 / D13D1165. Class II An inconsistency was identified related to electronic display identification of the optional Multilite Dye Handpieces of the RevLite SI Laser system that may confuse user. ConBio, a CynoSure Company
Devices DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs Monitor: Product Usage: Monitor, Physiological, Patient Catalog numbers 3011992, 3011992W, 3011993, 3011993W, 3011994, 3011994W, 3011996, 3011996W, 3014268 and 3014268W. Class II The firm is recalling these power cables due to a latent design reliability issue and the potential for shorting which can result in heating/melting of the cable jacket. Medrad Inc
Devices MAQUET GETINGE GROUP Arterial Cannula OD Used to introduce blood and sterile solutions into the systemic circulation during pediatric extracorporeal circulation procedures. Catalogue Number:Part Number: Lot Number are as follows: (1) 161410 (10 FR.):701022682:92056588 (2) 163610 (10 Fr):70102597:92059789 (3) 163608 (8 Fr.):70102.2681:92065640 (4) 163606 (6 Fr.):70102.2680:92063566 Class II The specified part numbers and lot numbers of Maquet Pediatric Arterial Cannula Packs may contain an incorrectly sized connector. Maquet Cardiovascular Us Sales, Llc
Devices Medtronic, Consulta® CRT-P, Model C4TR01, C3TR01 (not approved for US), and Syncra® CRT-P, Model C2TR01, Sterile EO. Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of AV synchrony. ATTACHMENT A: Affected SN List Lot Serial No PZX624804S PZX625573S PZX626117S PZX626118S PZX626136S PZX626137S PZX626138S PZX626139S PZX626140S PZX626141S PZX626142S PZX626143S PZX626144S PZX626145S PZX626146S PZX626147S PZX626148S PZX626149S PZX626150S PZX626151S PZX626152S PZX626153S PZX626154S PZX626155S PZX626156S PZX626157S PZX626158S PZX626159S PZX626160S PZX626161S PZX626162S PZX626163S PZX626164S PZX626165S PZX626166S PZX626167S PZX626168S PZX626169S PZX626170S PZX626171S PZX626172S PZX626173S  ...
More
Class II Medtronic recently identified an issue with a subset of Consulta® CRT-P and Syncra® CRT-P devices during production. As of May 30, 2013, there have been no reported or confirmed device failures. However, because of the potential for malfunction, Medtronic is requiring the return of non-implanted devices manufactured between April 1 and May 13, 2013 for re-inspection. The issue is unique to specific Consulta and Syncra CRT-P devices and no other Medtronic device models are affected. This issue was identified as a result of an internal investigation that indicated a recent trend of increasing manufacturing rejects related to the weld of a connector bracket. An out-of-specification weld could result in a loss of device hermeticity and compromised device functionality. Medtronic Inc. Cardiac Rhythm Disease Management
Drugs Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil (SCALP OIL), 0.01 %, 118.28 mL (4 Fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA 32773; NDC 28105-149-04. Lot #: H110940, Exp 08/13 Class III Subpotent Drug: the active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing. Hill Dermaceuticals, Inc.
Devices Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, 8F and Model # LA6IMAD, Lot # 0006724224, 6F Product Usage: The Medtronic Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system. Model # LA8EBU45SH, Lot # 0006722866 and Model # LA6IMAD, Lot # 0006724224. Class II Medtronic has identified a labeling issue for 24 units of the Launcher coronary Guide Catheter. The two affected catheter lots are mislabeled and do not accurately reflect the catheters contained within each package. Medtronic Inc. Cardiac Rhythm Disease Management
Devices Cordis a Johnson & Johnson Company, RadialSource Spring Wire Transradial Access Kit. Manufacturer Greatbatch Medical 2300 Berkshire Lane North, Minneapolis, MN 55441, Distributor Cordis Corporation 14201 North West 60th Avenue, Miami Lakes, Florida 33014. Baxter's lnfusors SV Elastomeric Infusion Device is a single-use, disposable elastomeric infusion pump indicated tor patients requiring slow, continuous intravenous, intra-arterial, subcutaneous, or epidural administration of medications at a constant flow rate. The device is also indicated for the administration of bolus doses of medication upon patient demand when used in conjunction with the Patient Control Module. lt is suitable for use in the hospital or home setting. Manufacturing Lot : W18499722 Class II Cordis Corporation, Inc and Greatbatch Medical are recalling one lot of the cordis RADIALSOURCE Spring Wire Transradial Access Kit product. Some units were manufactured with an undersized vessel dilator tip, too small to slide over the guidewire. Greatbatch Medical
Food See's Milk Raisins: Ingredients: Raisins, Sugar, Cocoa butter, milk chocolate, soy lecithin, Vanillin, Dextrin, Confectionery glaze.May contain traces of eggs, tree nuts and peanuts Sold in Net Wt. 8 oz (227 g) clear plastic packages or purchased by customer at counter in See's Stores. UPC 7 37666 08306 0 Manufactured by: See's Candy Shops Incorporated So. San Francisco, CA 04080 All lots. Class I Potential for nuts and/or nut and egg residue may be present in some of the dark and milk chocolate covered raisins. See's Candies Inc.
Food See's Dark Raisins: Ingredients: Raisins, Sugar,chocolate, cocoa butter, butter (milk), vanilla, soy lecithin, Dextrin, Confectionery glaze. May contain traces of eggs, tree nuts and peanuts. Sold in Net Wt. 8 oz (227 g) clear plastic packages or purchased by customer at counter in See's Stores. UPC 7 37666 08305 3 Manufactured by: See's Candy Shops Incorporated So. San Francisco, CA 04080 All lots. Class I Potential for nuts and/or nut and egg residue may be present in some of the dark and milk chocolate covered raisins. See's Candies Inc.
Veterinary BUPRENORPHINE HCl PF (C) INJECTABLE STRENGTHS: 0.15 mg/ml , 0.6 mg/ml NDC: 49452825301, G9064-0122-10 LOTS: 130107:18@27, 130115:03@22, 130308:34@45, 130405:34@40, 130416:69@97, 1302026:46@22, 130118:95@126, 130401:77@17, 130521:85@124 Class II Diamondback Drugs is recalling Buprenorphine HCL PF (C) Injectable due to an issue with the long-term stability of the product. Use of the Buprenorphine HCL PF (C) Injectable may not deliver the level of therapeutic relief from pain as expected. Diamondback Drugs of Delaware, LLC
Food Wawa Black Forest Ham and Cheese on a Pretzel Roll with swiss cheese and country dijon honey mustard. Net Wt. 8.7 oz (247g). Distributed by Wawa, Inc., Wawa, PA 19063. sell by 06/23/13 TFNJ 170 5:00am. Class I Taylor Farms New Jersey, Inc. of Swedesboro, NJ is voluntarily recalling a limited quantity of Black Forest Ham and Cheese on a Pretzel Roll with swiss cheese and country dijon honey mustard because they have the potential of containing an undeclared tree nut allergen. Taylor Farms New Jersey, NJ
Show all Code Info
-
-