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U.S. Department of Health and Human Services

Enforcement Report - Week of July 31, 2013

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Red Blood Cells (Apheresis) 2302264(Part A), 2302264(Part B) Class III Blood products, for which RBC volume QC. failed, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells GP92319 Class II Blood product, possibly contaminated with air, was distributed. Blood Bank of San Bernardino and Riverside Counties
Biologics Source Plasma 5497515,5493852 ,5490646 ,5435494 ,03ATXD8952 , 03ATXD8350 ,030WID5154 ,03ATXD7245 ,030WID4563 , 03ATXD6718 ,92426047 ,03ATXD3475 ,03ATXD2073 , 81844791 ,90023088 ,82899691 ,95029559 ,85507142 , 82896096 ,85505056 ,85500884 ,85498747 ,85486683 , 85485266 ,85481107 ,85479753 ,03HWVA3474 ,03HWVA3195 , 03HWVA2891 ,86233026 ,91312808 ,86228411 ,82430757 , 84098917 ,82429966 ,03PWVA2307 ,03TOHA2187 , 86219440 ,86220002 ,82426606 ,82425036 ,82420130 , 03DOHA1086 ,92648463 ,03TOHA1911 ,86214001 , 03PWVA1959 ,03GNCA2128 ,03DOHA0820 ,92645622 , 03TOHA1495 ,86204644 ,03GNCA1686 ,84087836 , 03TOHA1246 ,92406469 ,86199322 ,03DOHA0556 , 03DOHA0550 ,92641945 ,03TOHA0874 ,03RMIA0654 , 03DOHA0316 ,86186377 ,03DOHA0140 ,03TOHA0491 , 03RMIA0283 ,86177009 ,03RMIA0029 ,03TOHA0119 , 86175647 ,86166454 ,86165099 ,80447573D ,78336018 , 83706882D ,86155540 ,85432956D ,80442387 ,78333659 , 83703348D ,86150835 ,02DOHA3331 ,80438250D , 78331532 ,02DOHA3186 ,86141208 ,80433217D , 78440258D ,86136051D ,02LKYB2845 ,02LKYB2784 , 84811394D ,84811417D ,78438170T ,02DIAD2181 , 02RVAB6902 ,78436657T ,84805331D ,84805355D , 02LKYB2562 ,02GMIG0005 ,02MWII0872 ,02RVAB6689 , 02LKYB2536 ,02MWII0572 ,02RVAB6486 ,84795588D , 84792952D ,84789907 ,84788535D ,91056498 , 02RVAB6064 ,85408876D ,70551013D ,02LKYB1703 , 02LKYB1587 ,80392118D ,02FNDH0949 ,02HHIC0478 , 02HHIC0177 ,02LKYB1337 ,02HHIC0044 ,020NEA2959 , 020NEA2931 ,02BVAA6836 ,02HHIB9703 ,02BVAA6692 , 020NEA2804 ,68262181D ,68262754D ,91269874 , 020NEA2697 ,71336855D ,68262167D ,02BVAA6395 , 91227164 ,68260965D ,68260293D ,020NEA2582 , 68259877D ,83308802D ,71334868D ,68259303D , 020NEA2586 ,02BVAA6300 ,68257927D ,83307744D , 77683762D ,77684066D ,68258269 ,77682123D , 1330631D ,02BVAA6027 ,71328522D ,68253257D , 02BVAA5920 ,77690296D ,66915546 ,91007322 , 71323985D ,02BVAA5695 ,90436505D ,020NEA2729 , 02BVAA5468 ,02BVAA5367 ,90432507D ,81078882D , 02BVAA5240 ,90200380 ,81073832D ,67978755D , 66903741 ,02BVAA5104 ,67977055D ,02BVAA5019 , 02BVAA4969 ,81064540D ,02BVAA4876 ,69045165D , 66898252 ,02BVAA4692 ,78119178D ,02BVAA4628 , 02BVAA4570 ,78115538D ,70515428D ,02BVAA4531 , 80318767D ,02BVAA4342 ,78108844 ,80315599D , 78106499 ,70512298D ,90084973 ,78976757T , 78976344T ,90082351 ,02BVAA3966 ,77976543D , 78973367T ,78972377T ,78863408 ,77899798 , 02LKYB0451 ,77896940 ,78861435 ,02RMIA8056 , 78970311T ,02RMIA7895 ,77891143 ,70037081D , 77328847 ,77867476 ,79916813D ,70031980D , 78967007D ,80275343 ,70026634D ,77325211 , 80272328D ,79907736D ,77322890 ,81226528D , 02GNCA7174 ,74021680D ,80266624D ,70017588D , 79902946D ,66505969D ,77321657 ,70012835D , 81221325D ,79899161D ,66502142D ,81216024D , 66497936D ,77320247 ,81211418D ,77318718 , 02GNCA5866 ,78993907T ,81206643D ,02GNCA5693 , 77316936 ,77315496 ,02RVAA5459 ,02RVAA5130 , 02RVAA4842 ,76731297D ,02RVAA4667 ,02RVAA4250 , 02RVAA4209 ,02RVAA4017 ,02RVAA4030 ,6010210821 , 80857105D ,75384067 ,020NEA0135 ,75940010 , 75937270 ,75930646 ,75379285 ,75371470 , 74858248 ,76559648 ,ZR083538 ,63020052D , 63015331D Class II Blood products, which were not quarantined subsequent to receiving information regarding a post donation information related to vCJD risk, were distributed. BioLife Plasma Services L.P.
Biologics Red Blood Cells Leukocytes Reduced LF32303 Class II Blood products, collected from a donor who traveled to a malarial endemic area, were distributed. Tri-Counties Blood Bank dba UBS- Central Coast
Biologics Platelets Pheresis Leukocytes Reduced LF33971; LF32872; LF32576; LF34288 Class II Blood products, collected from a donor who traveled to a malarial endemic area, were distributed. Tri-Counties Blood Bank dba UBS- Central Coast
Biologics Red Blood Cells Leukocytes Reduced GW70580 Class II Blood product, positive for the c-antigen but labeled as c-antigen negative, was distributed. Tri-counties Blood Bank
Biologics Red Blood Cells Leukocytes Reduced LG82166; GX06220 Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Tri-counties Blood Bank
Biologics Platelets 1761509 Class II Blood products, that were possibly contaminated with Enterococcus Faecalis, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Fresh Frozen Plasma 1761509 Class II Blood products, that were possibly contaminated with Enterococcus Faecalis, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells 4590944 Class II Blood product, which was positive for E antigen was distributed to a recipient who was identified with an E antibody. Florida Blood Services, Inc.
Biologics Red Blood Cells 7971994 Class III Blood product, collected from a deferred donor who was improperly re-entered, was distributed. ONEBLOOD, Inc.
Biologics Blood and Blood Products for Reprocessing 007FC25436 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 007FC25436 Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Blood and Blood Products for Reprocessing 06GG78505;06GV43156 Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 06GG78505;06GV43156 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 06GP73413 Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Fresh Frozen Plasma 06GP73413 Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Red Blood Cells 2648780 Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Platelets Pheresis Leukocytes Reduced Irradiated 2648780 Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Platelets Pooled Leukocytes Reduced 2929086 Class II Blood product, manufactured from a unit of whole blood with incorrect volume was distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells Leukocytes Reduced W03940851263400 Class III Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Florida Blood Services, Inc.
Biologics Source Plasma 4190070246;4190069532;4190069192;4190027129;4190026840;4190026121;4190025997;4190025272;4190024519;4190024119;4190023368;4190023222;4190017364;4190016544;4190016270;4190015917;4190015709;4190015318;4190015102;4190014641;4190014263;4190014099;4190013711;4190013478;4190013121;4190012934;4190012550;4190012358;4190081815;4190080585;4190080216;4190079168;4190078417;4190077735;4190077089;4190076142;4190075613;4190074971;4190074511;4190073983;4190072666;4190072341;4190071308;4190069854;4190069408;4190068507;4190068082;4190067326;4190066902;4190066244;4190065743;4190064942;4190064667;4190063980;4190063661;4190062560;4190062010;4190061360;4190060923;4190060380;4190059961;4190059491;4190059058;4190058581;4190058157;4190057508;4190057160;4190056551;4190056074;4190055667;4190055221;4190054530;4190053927;4190053665;4190052787;4190052555 Class III Blood products, collected from donors who were permanently deferred, were distributed. CSL Plasma, Inc.
Biologics Source Plasma 3960123216; 39601223330 ; 3960121814; 3960121011; 3960120309; 3960119657; 3960118638; 3960118139; 3960117309; 3960116824; 3960116024; 3960115424; 3960114675; 3960114100; 3960113325; 3960112818; 3960111726; 3960111298; 3960110490; 3960110001; 3960109024; 3960108623 3960107840 ; 3960107405 3960106731; 3960106364; 3960105290; 3960104517; 3960103998 3960102975;3960102538;3960101812;3960101424;3960100773;3960100260;3960098952;3960098445;3960097648;3960097126;3960096356;3960095962;3960095108;3960094706;3960093927;3960093398;3960092616;3960092134;3960091377;3960090872;3960090173;3960089676;3960088833;3960088441;3960087651;3960087225;3960080644;3960080277;3960079574;3960079152;3960078711;3960078203;3960077670;3960077255;3960076712;3960076267;3960075531;3960075322;3960074558;3960074350;3960073705;3960073499;3960066335;3960065987 Class III Blood products, collected from donors whose suitability to donate were not adequately determined, were distributed. Talecris Plasma Resources, Inc.
Biologics Blood and Blood Products for Reprocessing W128710072059 Class II Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Delta Blood Bank
Devices Eon and Eon Mini charging system, model numbers Eon -3701 (Wall Charger), 3711 (Portable Charger) and Eon Mini -3721 (Charger); This is a continuation of the firm's July 2012 recall. Product Usage: The Eon Wall Charger (3701) provides the capability to recharge the IPG Battery. The charger transmits RF energy through the antenna to the IPG battery to recharge it. The Eon Portable Charger (3711) provides the capability to recharge the IPG battery. The charger transmits RF energy through the antenna to the IPG battery to recharge it. The patient can be mobile during the recharging process with a portable charger. The Eon Mini Charger (3721) provides the capability to recharge the IPG battery while stimulation is either on or off. The charger transmits RF energy through the antenna to the IPG battery to recharge it. All serial numbers manufactured Class II There is issues of warmth or heating at the implant site during charging for the Eon Mini implantable pulse generators (IPGs). In the July 2012 letter St. Jude Medical informed customers that they would be implementing design improvements to the charger to address possible increased energy dissipation when the charger is misaligned with the IPG or the IPG is implanted too near the surface of the skin. This field action is to announce the availability of the newly designed Eon Mini Charger Model 3722 to mitigate excessive heating while charging. St. Jude Medical
Drugs Mitosol (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use (NDC 49771-002-01), 3 kits per box (NDC 49771-002-03), Rx only, Manufactured for: Mobius Therapeutics, LLC, 4041 Forest Park Avenue, St. Louis, MO 63108 USA. Lot #: M086920 and M098260, Exp. 08/2013 Class I Non-Sterility: one or more components of the kit have been found to be contaminated with yeast. Mobius Therapeutics LLC
Veterinary Nature's Deli Chicken Jerky Dog Treats, 2.5 lbs. bag, UPC 647263800208, 3 lbs UPC 647263800215, 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 dates of 04202013 DEN to 10032013 DEN excluding Best By 09192013 DEN, which was recalled on 10/03/2012. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary Boots & Barkley Loving your pet from head to tail. Roasted American Pig Ears. Delicious Treat for Dogs, Made in the U.S.A. Distributed by TARGET Corporation, Minneapolis, MN 55403, net wt 12 oz, 12 count, UPC 647263899158. Best By dates of 20APR2014 DEN to 03OCT2014 DEN, excluding Best By 13SEP2014DEN, which was recalled on 10/17/2012. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary Boots & Barkley Loving your pet from head to tail. American Variety Pack Real Beef & Pork. Treats for Dogs. Product of U.S.A. Distributed by TARGET Corporation, Minneapolis, MN 55403, net wt 32 oz. Packaging is white, blue and red with red, black and blue print writing, UPC 490830400086. Best by dates of 20APR2014 DEN to 03OCT2014 DEN, excluding Best By 13SEP2014DEN, which was recalled on 10/17/2012. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary Boots & Barkley American Beef Bully Stick, 12 inch. Satisfies your dog's instinctive urge to chew. Ingredients: Beef Pizzles. Distributed by TARGET Corporation, Minneapolis, MN 55403, 2012 Target Brands, Inc. Made in U.S.A. Packaging is transparent with white, blue and red with red, black and blue print writing on the affixed label, UPC 085239043165. Best By dates of 20APR2014 DEN to 03OCT2014 DEN. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary Boots & Barkley American Smoked Beef Femur Bone 3 inch. Satisfies your dog's instinctive urge to chew. Ingredients: Beef Femur Bone. Distributed by TARGET Corporation, Minneapolis, MN 55403, 2012 Target Brands, Inc. Made in U.S.A. Packaging is transparent with white, blue and red with red, black and blue print writing on the affixed label, UPC 085239403495. Best By dates of 20APR2014 DEN to 03OCT2014 DEN. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary Boots & Barkley American Beef Tendon Flossie 6-8 inch. Satisfies your dog's instinctive urge to chew. Ingredients: Beef Tendon. Distributed by TARGET Corporation, Minneapolis, MN 55403, 2012 Target Brands, Inc. Made in U.S.A. Packaging is transparent with white, blue and red with red, black and blue print writing on the affixed label, UPC 085239043103. Best By dates of 20APR2014 DEN to 03OCT2014 DEN. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary Boots & Barkley American Pig Ear Strips 8 oz. Satisfies your dog's instinctive urge to chew. Ingredients: Pig Ears. Distributed by TARGET Corporation, Minneapolis, MN 55403, 2012 Target Brands, Inc. Made in U.S.A. Packaging is transparent with white, blue and red with red, black and blue print writing on the affixed label, UPC 085239403440. Best By dates of 20APR2014 DEN to 03OCT2014 DEN. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary Boots & Barkley Chicken Stuffed American Beef Femur Bone, 6 inch. Satisfies your dog's instinctive urge to chew. Ingredients: Beef Femur Bone Chicken Breast, Natural Flavorings. Distributed by TARGET Corporation, Minneapolis, MN 55403, 2012 Target Brands, Inc. Made in U.S.A. Packaging is transparent with white, blue and red with red, black and blue print writing on the affixed label, UPC 085239043202. Best By dates of 20APR2014 DEN to 03OCT2014 DEN. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary Boots & Barkley American Braided Beef Bully Stick, 5 inch. Satisfies your dog's instinctive urge to chew. Ingredients: Beef Pizzles. Distributed by TARGET Corporation, Minneapolis, MN 55403, 2012 Target Brands, Inc. Made in U.S.A. Packaging is transparent with white, blue and red with red, black and blue print writing on the affixed label, UPC 085239043110. Best By dates of 20APR2014 DEN to 03OCT2014 DEN. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary Boots & Barkley American Chicken Jerky, 16 oz UPC 085239043325; 8 oz UPC 085239043400. Satisfies your dog's instinctive urge to chew. Ingredients: Chicken Breast, Natural Flavorings. Distributed by TARGET Corporation, Minneapolis, MN 55403, 2012 Target Brands, Inc. Made in U.S.A. Packaging is semi-transparent with white, blue and red with red, black and blue print writing on the affixed label. The labeling also has digital photos of the chicken strips and a picture of a terrier dog. Best By dates of 20APR2014 DEN to 03OCT2014 DEN. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary Boots & Barkley American Beef Knuckle, 14 oz. Promotes Plaque and Tartar Reduction. Ingredients: Beef Knuckle. Distributed by TARGET Corporation, Minneapolis, MN 55403, 2012 Target Brands, Inc. Packaging is semi-transparent with white, blue and red with red, black and blue print writing on the affixed label. The labeling also has digital photo of a dog. UPC 647263899172. Best By dates of 20APR2014 DEN to 03OCT2014 DEN. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary Boots & Barkley American Pork Femur, 1 bone. Promotes Plaque and Tartar Reduction. Ingredients: Pork Femur. Distributed by TARGET Corporation, Minneapolis, MN 55403, 2012 Target Brands, Inc. Packaging is semi-transparent with white, blue and red with red, black and blue print writing on the affixed label. The labeling also has digital photo of a dog. UPC 647263899165. Best By dates of 20APR2014 DEN to 03OCT2014 DEN. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary BIXBI Skin and Coat Beef Liver Jerky, 5 oz. Packaged in orange semi-transparent flexible plastic packaging, 100% USA Made and Sourced, UPC 091037018021. Best By dates of 04202014 DEN to 10032014 DEN. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary BIXBI Skin and Coat Lamb Jerky, 5 oz. Packaged in purple and orange semi-transparent flexible plastic packaging with black and transparent print writing, 100% USA Made and Sourced, UPC 091037018045. Best By dates of 04202014 DEN to 10032014 DEN. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary BIXBI Hip and Joint Pork Jerky, 5 oz. Packaged in yellow and aqua semi-transparent flexible plastic packaging with black and transparent print writing, 100% USA Made and Sourced, UPC 091037018144. Best By dates of 04202014 DEN to 10032014 DEN. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary BIXBI Skin and Coat Chicken Breast Jerky Treats, 5 oz. Packaged in orange and green semi-transparent flexible plastic packaging with black and transparent print writing, 100% USA Made and Sourced, UPC 091037018007. Best By dates of 04202014 DEN to 10032014 DEN. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary BIXBI Skin and Coat Pork Jerky, 5 oz. Packaged in orange and aqua semi-transparent flexible plastic packaging with black and transparent print writing, 100% USA Made and Sourced, UPC 091037018069. Best By dates of 04202014 DEN to 10032014 DEN. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary BIXBI Hip and Joint Lamb Jerky, 5 oz. Packaged in yellow and purple semi-transparent flexible plastic packaging with black and transparent print writing, 100% USA Made and Sourced, UPC 091037018120. Best By dates of 04202014 DEN to 10032014 DEN. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary BIXBI Hip and Joint Chicken Breast Jerky, 5 oz. Packaged in yellow and green semi-transparent flexible plastic packaging with black and transparent print writing, 100% USA Made and Sourced, UPC 091037018083. Best By dates of 04202014 DEN to 10032014 DEN. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary BIXBI Hip and Joint Beef Liver Jerky, 5 oz. Packaged in yellow and red semi-transparent flexible plastic packaging with black and transparent print writing, 100% USA Made and Sourced, UPC 091037018106. Best By dates of 04202014 DEN to 10032014 DEN. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary Sam's Club Roasted Pig Ear Dog Treats, 28 oz, UPC 681131857246. Best By dates of 04202014 DEN to 10032014 DEN. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary Petco Natural Pig Ears, 25 pk, UPC 800443092903, 12 pk UPC 800443092910, 7 pk UPC 800443092934. Best By dates of 04202014 DEN to 10032014 DEN. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary Petco Smoked Pig Ears, 7 pk, UPC 800443092941, 12 pk UPC 800443092927. Best By dates of 04202014 DEN to 10032014 DEN. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary Colorado Naturals Chicken Chips, 16 oz, UPC 647263800291, Distributed by Petco/Kasel Ind. Best By dates of 04202014 DEN to 10032014 DEN. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary Colorado Naturals Salmon Jerky, 4 oz UPC 647263900175. Distributed by Petco/Kasel Industries. Best By dates of 04202014 DEN to 10032014 DEN. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary Colorado Naturals Chicken Jerky, 4 oz UPC 647263800178, 16 oz UPC 647263800291. Distributed by Petco/Kasel/Menards Industries. Best By dates of 04202014 DEN to 10032014 DEN. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary Colorado Naturals Lamb Jerky, 4 oz UPC 647263510176, Distributed by Petco/Kasel Industries. Best By dates of 04202014 DEN to 10032014 DEN. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary Colorado Naturals Pork Jerky, 16 oz UPC 647263700157, Distributed by Petco/Kasel Industries/Menards. Best By dates of 04202014 DEN to 10032014 DEN. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary Colorado Naturals Beef Jerky, 4 oz UPC 647263801175, Distributed by Petco/Kasel Industries. Best By dates of 04202014 DEN to 10032014 DEN. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary TDBBS, Inc/Best Bully Sticks Buffalo Hearts Sliced, 3 lbs, Bulk. Best By dates of 04202014 DEN to 10032014 DEN. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary TDBBS, Inc/Best Bully Sticks Knee Caps, 25 ct, Bulk. Best By dates of 04202014 DEN to 10032014 DEN. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary TDBBS, Inc/Best Bully Sticks Pork Jerky Strips, 16 oz. Best By dates of 04202014 DEN to 10032014 DEN. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary TDBBS, Inc/Best Bully Sticks Chicken Jerky, 16 oz. Best By dates of 04202014 DEN to 10032014 DEN. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary TDBBS, Inc/Best Bully Sticks Turkey Cubes, 4.5 oz. Best By dates of 04202014 DEN to 10032014 DEN. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary TDBBS, Inc/Best Bully Sticks Pig Snouts, 25 ct, Bulk. Best By dates of 04202014 DEN to 10032014 DEN. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary TDBBS, Inc/Best Bully Sticks Beef Lobster Tails, 1ct, Bulk. Best By dates of 04202014 DEN to 10032014 DEN. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary TDBBS, Inc/Best Bully Sticks Turkey Jerky Sticks, 6 ct. Best By dates of 04202014 DEN to 10032014 DEN. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary TDBBS, Inc/Best Bully Sticks hearts of Lamb, 4 oz. Best By dates of 04202014 DEN to 10032014 DEN. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary TDBBS, Inc/Best Bully Sticks Lamb Jerky, 4 oz. Best By dates of 04202014 DEN to 10032014 DEN. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary Nutri-Pet 16oz Natural Filet Strips, UPC 76-0081. Best By dates of 04202014 DEN to 10032014 DEN. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary K9 Chicken Joint Jerky 5oz UPC 669125507049; 15oz, UPC 669125507056 Best By dates of 04202014 DEN to 10032014 DEN. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary K9 Chicken Coat Jerky 5oz; UPC 669125507063; 15oz, UPC 669125507070 Best By dates of 04202014 DEN to 10032014 DEN. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary K9 Chicken Calming Jerky 5oz, UPC 669125507087 ; 15oz , UPC 669125507094 Best By dates of 04202014 DEN to 10032014 DEN. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary K9 Chicken Breath Fresh Jerky 5oz, UPC 669125507100 ; 15oz , UPC 669125507117 Best By dates of 04202014 DEN to 10032014 DEN. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary K9 Chicken Senior Jerky 5oz, UPC 669125507124. Best By dates of 04202014 DEN to 10032014 DEN. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary K9 Chicken Digestive Jerky 5oz, UPC 669125507148. Best By dates of 04202014 DEN to 10032014 DEN. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary K9 Chicken Healthy Weight Jerky 5oz, UPC 669125507162. Best By dates of 04202014 DEN to 10032014 DEN. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary K9 Chicken Jerky 5oz, UPC 669125507018 ; 8oz , UPC 669125507025; 16oz , UPC 669125507032 Best By dates of 04202014 DEN to 10032014 DEN. Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary K9 Hip & Joint Chicken Strips 8oz, UPC 669125990445 Best By dates of 04202014 DEN to 10032014 DEN Class I Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. Kasel Associates Industries, Inc.
Veterinary Verve, 4lb box, 6 units/case, Item# V4, UPC 183413000 89 5, and 10 lb box, 4 units/case, Item #VR, UPC 183413000 17 8. Item Code: V4 + VR, Lot # 2332A (batches 1-3). Item Code: VR, Lot # 3062A (batches 8 & 9). Class I The Honest Kitchen is recalling five lots of its Verve, Zeal and Thrive pet food products because they have the potential to be contaminated with Salmonella. Honest Kitchen
Veterinary Free Thrive, 1 oz. sample, 50 units/case, Item#TMC, UPC 183413000 81 9. Lot # 2622A (batch 3) Class I The Honest Kitchen is recalling five lots of its Verve, Zeal and Thrive pet food products because they have the potential to be contaminated with Salmonella. Honest Kitchen
Veterinary Zeal, 4lb box, 6 units/case, Item#Z4, UPC 18341300195 3, and 10lb box, 4 units/case, Item# ZR, UPC 18341300191 5. Item Code: Z4 + ZR, Lot # 2272A (batches 1-5). Item Code: ZR, Lot # 2652A (batches 1-4). Class I The Honest Kitchen is recalling five lots of its Verve, Zeal and Thrive pet food products because they have the potential to be contaminated with Salmonella. Honest Kitchen
Veterinary Kaytee Fiesta Max Canary/Finch, Net Wt. 2 lb., UPC 71859-40410 Best Before Code (month/day/year) 9/28/2013 thru 5/7/2014 Class I Kaytee Products is recalling several bird treats and greens items due to possible contamination of Salmonella from parsley flake ingredients supplied to Kaytee by Specialty Commodities, Inc. Central Garden Pet Company
Veterinary Kaytee Honey Treat, Parakeet, Net Wt. 3.5 oz, UPC 71859-00431, 3.5 oz UPC 71859-00434, and 7 oz Value Pack UPC 71859-55027 Best Before Code (month/day/year) 12/4/2013 thru 8/2/2014 Class I Kaytee Products is recalling several bird treats and greens items due to possible contamination of Salmonella from parsley flake ingredients supplied to Kaytee by Specialty Commodities, Inc. Central Garden Pet Company
Veterinary Kaytee Fiesta Fruit & Veggie Treat, Parakeet, Net Wt. 3.5 oz, UPC 71859-99885, 9.5 oz UPC 71859-99855, Best Before Code (month/day/year) 12/18/2013 thru 7/31/2014 Class I Kaytee Products is recalling several bird treats and greens items due to possible contamination of Salmonella from parsley flake ingredients supplied to Kaytee by Specialty Commodities, Inc. Central Garden Pet Company
Veterinary Kaytee Forti-Diet Pro Health Honey Treat, Parakeet, Net Wt. 3.5 oz, UPC 71859-94235, 7 oz Value Pack UPC 71859-94236 Best Before Code (month/day/year) 12/4/2013 thru 8/1/2014 Class I Kaytee Products is recalling several bird treats and greens items due to possible contamination of Salmonella from parsley flake ingredients supplied to Kaytee by Specialty Commodities, Inc. Central Garden Pet Company
Veterinary Kaytee Forti-Diet Pro Health Munchables Shred-A-Box, Honey Seed Treats, Parakeet, 4 boxes, Net Wt. 2 oz, UPC 71859-94268 Best Before Code (month/day/year) 3/7/2014 thru 7/30/2014 Class I Kaytee Products is recalling several bird treats and greens items due to possible contamination of Salmonella from parsley flake ingredients supplied to Kaytee by Specialty Commodities, Inc. Central Garden Pet Company
Veterinary Kaytee Forti-Diet Pro Health Molting & Conditioning, Small Birds, Net Wt. 11 oz, UPC 71859-94264 Best Before Code (month/day/year) 12/25/2013 thru 8/5/2014 Class I Kaytee Products is recalling several bird treats and greens items due to possible contamination of Salmonella from parsley flake ingredients supplied to Kaytee by Specialty Commodities, Inc. Central Garden Pet Company
Veterinary Kaytee Fiesta Nutty Papaya Treat, Parakeet & Cockatiel, Net Wt. 2.25 oz, UPC 71859-94368 Best Before Code (month/day/year) 12/4/2013 thru 6/25/2014 Class I Kaytee Products is recalling several bird treats and greens items due to possible contamination of Salmonella from parsley flake ingredients supplied to Kaytee by Specialty Commodities, Inc. Central Garden Pet Company
Veterinary Kaytee Fiesta Foraging Treat for Pet Birds, Net Wt. 1.5 oz, UPC 71859-94370 Best Before Code (month/day/year) 1/27/2014 thru 5/29/2014 Class I Kaytee Products is recalling several bird treats and greens items due to possible contamination of Salmonella from parsley flake ingredients supplied to Kaytee by Specialty Commodities, Inc. Central Garden Pet Company
Veterinary Grreat Choice Treat Sticks for Small Birds, Net Wt. 3.2 oz, UPC 37257-27166, 9.6 oz, UPC 37257-27165 Best Before Code (month/day/year) 12/10/2013 thru 3/19/2014 Class I Kaytee Products is recalling several bird treats and greens items due to possible contamination of Salmonella from parsley flake ingredients supplied to Kaytee by Specialty Commodities, Inc. Central Garden Pet Company
Veterinary Kaytee Foraging Box O' Fun Treat for Pet Birds, Net Wt. 1.5 oz, UPC 71859-94615 Best Before Code (month/day/year) 1/28/2014 thru 7/30/2014 Class I Kaytee Products is recalling several bird treats and greens items due to possible contamination of Salmonella from parsley flake ingredients supplied to Kaytee by Specialty Commodities, Inc. Central Garden Pet Company
Veterinary Kaytee Bird Greens Foraging Treat, Net Wt. 1 oz, UPC 71859-94708 Best Before Code (month/day/year) 12/1/2013 thru 5/28/2014 Class I Kaytee Products is recalling several bird treats and greens items due to possible contamination of Salmonella from parsley flake ingredients supplied to Kaytee by Specialty Commodities, Inc. Central Garden Pet Company
Veterinary Dog treat products as follows: a) Jones Natural Chews Co Woofers (beef patties), bulk 50 count box, Item UPC 741956008169 (may be sold individually at retail) b) Jones Natural Chews Co Woofers (beef patties), 1 pack shrink-wrap, 50 count box, Item UPC 741956008657 c) Jones Natural Chews Co Woofers (beef patties), 1 pack shrink-wrap, 50 count box, Item UPC 741956008183 d) Jones Natural Chews Co Woofers (beef patties) 2 pack shrink-wrap, 25 count box, Item UPC 741956008190 a) Lot 2962GPS, Best By 10/22/15, and Lot 2892PAL, Best By 10/15/15 b) Lot 3102, Best By 11/05/15 c) Lot 2892BF, Best By 10/15/15, Lot 2962PWV, Best By 10/22/15, Lot 2962ASC, Best By 10/22/15, and Lot 3032ASL, Best By 10/29/15 d) Lot 2962ASC, Best By 10/22/15, and Lot 3032ASL, Best By 10/29/15. Class I This product is being recalled due to the possible risk of Salmonella. Jones Natural Chews, Co., Inc.
Drugs Magnesium Sulfate 2 grams in Dextrose 5% for Injection, in 50 mL Plastic Infusion Bags, Med Prep Consulting Inc., Tinton Falls, NJ 07712 All lots Class I Non-Sterility; mold contamination Med Prep Consulting, Inc.
Drugs All Compounded Products, packaged in plastic infusion bags, devices, syringes and glass vials, Med Prep Consulting Inc., Tinton Falls, NJ 07712 All lots Class II Lack of Assurance of Sterility; potential for mold contamination Med Prep Consulting, Inc.
Food 365 Organic 100% Apple Juice from concentrate with Vitamin C and Calcium in 6.75 fl oz (UPC 0 99482 42095 6) and 64 fl oz. (UPC 0 99482 42096 3) Distributed by: Whole Foods Market, Austin, TX 78703; 8 units peer shipping case 6.75 fl oz (UPC 0 99482 42095 6) - Expiration dates 2/14/2014 & 02/15/2014; 64 oz (UPC 0 99482 42096 3) - Expiration dates 1/15/2014, 1/29/2014, 2/12/2014, 2/18/2014, 2/27/2014, 3/11/2014, and 3/25/2014. Class II Elevated patulin levels. Whole Foods Market
Biologics Red Blood Cells (Apheresis) W050912005453; Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. HCSC-Blood Center
Biologics Fresh Frozen Plasma (Apheresis) W050912005453; Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. HCSC-Blood Center
Biologics Red Blood Cells Irradiated W050912008713; Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. HCSC-Blood Center
Biologics Red Blood Cells W050912002027; W050912009851; Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. HCSC-Blood Center
Biologics Red Blood Cells Leukocytes Reduced W050912009111; W050912000741; Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. HCSC-Blood Center
Biologics Blood and Blood Products for Reprocessing W050912009111; W050912002027; W05091009851; W050912000741; Class III Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. HCSC-Blood Center
Food Master Cases, Product Code #8534 (6-12 count retail boxes) Label of master case bears the name: Donut House K -Cup Packs. 12-Count Retail Boxes, Product Code #8934, Donut House Decaffeinated K-Cup Packs Best By: 15NOV2013 PL113 3049 Class II Regular (caffeinated) Coffee individual K-cup packs were packaged inside multi unit retail boxes labeled Decaffeinated Coffee. Green Mountain Coffee Roasters
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W037711145273 Part 1; W037711145273 Part 2; Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Hoxworth Blood Center UC Medical Center
Biologics Red Blood Cells Leukocytes Reduced W038112346434; Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. Florida's Blood Centers - Lake Park
Biologics Source Plasma 0380099025; 0380098497; 0380098106; Class II Blood products, collected from a donor who did not have a complete physical examination, were distributed. Biotest Pharmaceuticals Corporation
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W149513934421Part 1 ; W149513934421Part 2; Class II Blood products, which were labeled as leukoreduced, but were not tested to verify the White Blood Cell count, were distributed Northern California Community Blood Bank
Drugs VIVITROL (naltrexone for extended-release injectable suspension) a) 380 mg vial NDC 65757-303-02, b) 380 mg vial in kit NDC 65757-300-01, Rx Only Manufactured and marketed by Alkermes, Inc., Waltham, MA 02451, Individual vial lot 402-3683AA, EXP 10/13; kit vial lot 2011-003, EXP 08/13 Class II Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing. Alkermes, Inc.
Biologics Red Blood Cells Leukocytes Reduced W042313005162D; Class II Blood products, which were not manufactured in accordance to acceptable product specifications, were distributed. Blood Systems, Inc
Biologics Red Blood Cells Leukocytes Reduced W038112371216; Class II Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. OneBlood, Inc.
Biologics Platelets Pooled Leukocytes Reduced W038112986694; Class II Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. OneBlood, Inc.
Biologics Source Plasma 3790262030; 3790281497; 3790260795; 3790260536; 3790260073; 3790259619; 3790259388; 3790258872; 3790258627; 3790257457; 3790256939; 3790258833; 3790256107; 3790255821; 3790255343; 3790255075; 3790254093; 3790253834; 3790253273; 3790252998; 3790252179; 3790251046; 3790250913; 3790250293; 3790249853; 3790249353; 3790248961; 3790248519; 3790248074; 3790247204; 3790248896; 3790248294; 3790245959; 3790245385; 3790245071; 3790244522; 3790244236; 3790243660; 3790262852; Class III Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. Talecris Plasma Resources Inc
Biologics Red Blood Cells Leukocytes Reduced W044412606060; Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. Northern Illinois Blood Bank dba Rock River Valley BC
Biologics Platelets Pheresis Leukocytes Reduced W227013003230; Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. Community Blood Center of Carolinas
Devices LIGACLIP® Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L Product Usage: The LIGACLIP Endoscopic Rotating Multiple Clip Applier is a sterile, single patient use instrument designed to provide a means of ligation through ENDOPATH® surgical trocars. The instrument delivers 20 titanium clips that individually advance after each firing. The shaft is made of a low glare material that minimizes reflective distortion. It is designed to rotate 360° in either direction. The rotating knob is located to allow for a one-handed technique. H44Z7W, 37ER320, 01/03/12 to 11/15/16; J4A016, 37ER320, 01/05/12 to 12/15/16; J4A11G, 37ER320, 01/10/12 to 12/15/16; J4A124, 37ER320, 01/10/12 to 12/15/16; J4A145 37ER320, 01/11/12 to 12/15/16 J4A182, 37ER320, 01/13/12 to 12/15/16; J4A21T, 37ER320, 01/27/12 to 12/15/16; J4A28D, 37ER320, 01/19/12 to 12/15/16; J4A28U, 37ER320, 01/19/12 to 12/15/16; J4A335, 37ER320, 01/23/12 to 12/15/16; J4A38L, 37ER320, 01/25/12 to 12/15/16; J4A39D, 37ER320, 01/26/12 to 12/15/16; J4A406, 37ER320, 01/26/12 to 12/15/16; J4A40P, 37ER320, 02/07/12 to 12/15/16; J4A45T, 37ER320, 01/29/12 to 12/15/16; J4A461, 37ER320, 01/30/12 to 12/15/16; J4A46T, 37ER320, 01/30/12 to 12/15/16; J4A48U,), 37ER320, 02/02/12 to 12/15/16; J4A49L, 37ER320, 02/01/12 to 12/15/16; J4A525, 37ER320, 02/02/12 to 12/15/16; J4A535, 37ER320, 02/02/12 to 12/15/16; J4A559, 41XBB48B 02/02/12 to 07/15/16; J4A60K, 37ER320, 02/08/12 to 01/15/17; J4A60W, 37ER320, 02/08/12 to 01/15/17; J4A61Z, 37ER320, 02/08/12 to 01/15/17; J4A62E, 37ER320, 02/08/12 to 01/15/17; J4A62U, 37ER320, 02/09/12 to 01/15/17; J4A71W, 37ER320, 02/15/12 to 01/15/17; J4A729, 37ER320, 02/15/12 to 01/15/17; J4A73H, 37ER320, 02/15/12 to 01/15/17; J4A743, 37ER320, 02/16/12 to 01/15/17; J4A74T, 37ER320, 02/16/12 to 01/15/17; J4A755, 37ER320, 02/16/12 to 01/15/17; J4A75P, 37ER320, 02/16/12 to 01/15/17; J4A86E, 37ER320, 02/24/12 to 01/15/17; J4A871, 37ER320, 02/25/12 to 01/15/17; J4A87L, 37ER320, 02/25/12 to 01/15/17; J4A889, 37ER320, 02/25/12 to 01/15/17; J4A92X, 41XBB48B 02/28/12 to 08/15/16; J4A97H, 37ER320, 03/02/12 to 01/15/17; J4A98T, 37ER320, 03/02/12 to 01/15/17; J4A997, 37ER320, 03/03/12 to 01/15/17; J4A99V, 37ER320, 03/03/12 to 02/15/17; J4AAOM, 37ER320, 03/03/12 to 02/15/17; J4AA1H, 37ER320, 03/05/12 to 02/15/17; J4AA71, 37ER320, 03/07/12 to 02/15/17; J4AA7V, 37ER320, 03/08/12 to 02/15/17; J4AA84, 37ER320, 03/08/12 to 02/15/17; J4AA9D, 37ER320, 03/08/12 to 02/15/17; J4AC2X, 37ER320, 03/10/12 to 02/15/17; J4AD09, 37ER320, 03/15/12 to 02/15/17; J4AD1A, 37ER320, 03/15/12 to 02/15/17; J4AD2G, 37ER320, 03/16/12 to 02/15/17; J4AE3W, 37ER320, 03/22/12 to 02/15/17; J4AE49, 37ER320, 03/22/12 to 02/15/17; J4AE57, 37ER320, 03/23/12 to 02/15/17; J4AE63, 37ER320, 03/23/12 to 02/15/17; J4AE6R, 37ER320, 04/13/12 to 02/15/17; J4AE7E, 37ER320, 04/11/12 to 02/15/17; J4AE86, 37ER320, 03/24/12 to 02/15/17; J4AE8L, 37ER320, 03/24/12 to 02/15/17; J4AF09, 41XBB48B, 03/27/12 to 10/15/16 84; J4AF15, 37ER320, 03/28/12 to 02/15/17; J4AF1N, 37ER320, 03/28/12 to 02/15/17; J4AF2G, 37ER320, 03/28/12 to 02/15/17; J4AF3K, 37ER320, 03/28/12" 02/15/17; J4AF48, 37ER320, 03/29/12 to 02/15/17; J4AF4J, 37ER320, 03/29/12 to 02/15/17; J4AGOV, 37ER320, 04/03/12 to 02/15/17; J4AG4V, 37ER320, 04/05/12 to 03/15/17; J4AG91, 37ER320, 04/11/12 to 03/15/17; J4AG9G, 37ER320, 04/18/12 to 03/15/17; J4AHOV, 37ER320, 04/12/12 to 03/15/17; J4AH8N, 37ER320, 04/15/12 to 03/15/17; J4AH96, 37ER320, 04/16/12 to 03/15/17; J4AH9C, 37ER320, 04/16/12 to 03/15/17; J4AH9R, 37ER320, 04/16/12 to 03/15/17; J4AJ3A, 37ER320, 04/18/12 to 03/15/17; J4AJ3T, 37ER320, 04/18/12 to 03/15/17; J4AJ6P, 37ER320, 04/20/12 to 03/15/17; J4AJ7M, 37ER320, 04/20/12 to 03/15/17; J4AKOP, 37ER320, 04/21/12 to 03/15/17; J4AK14, 37ER320, 04/22/12 to 03/15/17; J4AK1H, 37ER320, 04/23/12 to 03/15/17; J4AK1R, 37ER320, 04/23/12 to 03/15/17; J4AK2V, 37ER320, 04/24/12 to 03/15/17; J4AK35, 37ER320, 04/24/12 to 03/15/17; J4AK40, 37ER320, 04/24/12 to 03/15/17; J4AK5U, 37ER320, 04/25/12 to 03/15/17; J4AK67, 37ER320, 04/25/12 to 03/15/17; 2136; J4AK7D, 37ER320, 04/26/12 to 03/15/17; J4AK8C, 37ER320, 04/26/12 to 03/15/17; 1152; 4AK9R, 37ER320, 04/28/12 to 03/15/17; J4ALOU, 37ER320, 04/27/12 to 03/15/17; J4AL65, 37ER320, 05/02/12 to 03/15/17; J4AL6P, 37ER320, 05/02/12 to 03/15/17; 2172; J4AL87, 37ER320, 05/11/12 to 03/15/17; 2244; J4AL90, 37ER320, 05/03/12 to 04/15/17; J4AL9H, 37ER320, 05/03/12 to 04/15/17; J4AM11, 37ER320, 05/03/12 to 04/15/17; J4AM1K, 37ER320, 05/04/12 to 04/15/17; J4AM2E, 37ER320, 05/04/12 to 04/15/17; J4AM32, 37ER320, 05/04/12 to 04/15/17; J4AM3G, 37ER320, 05/05/12 to 04/15/17; J4AM45, 37ER320, 05/05/12 to 04/15/17; J4AM7R, 37ER320, 05/08/12 to 04/15/17; J4AM7W, 37ER320, 05/08/12 to 04/15/17; J4AM8H, 37ER320, 05/09/12 to 04/15/17; J4AM9J, 37ER320, 05/09/12 to 04/15/17; J4ANOC, 37ER320, 05/09/12 to 04/15/17; J4AN14, 37ER320, 05/09/12 to 04/15/17; J4AN1P, 37ER320, 05/10/12 to 04/15/17; J4AN1X, 37ER320, 05/10/12 to 04/15/17; J4AN2K, 37ER320, 05/10/12 to 04/15/17; J4AN35, 37ER320, 05/10/12 to 04/15/17; J4AR7E, 41XBB48B 05/24/12 to 01/15/17; J4AT2G, 37ER320, 06/02/12 to 04/15/17; 1152; J4AT2H, 37ER320, 05/31/12 to 04/15/17; J4AUOH, 37ER320, 06/04/12 to 04/15/17; J4AU23, 37ER320, 06/04/12 to 04/15/17; J4AU29, 37ER320, 06/05/12 to 05/15/17; J4AU2V, 37ER320, 06/05/12 to 05/15/17; J4AV5J, 37ER320, 06/12/12 to 05/15/17; J4AV5T, 37ER320, 06/12/12 to 05/15/17; J4AW02, 37ER320, 06/13/12 to 05/15/17; J4AWOG, 37ER320, 06/14/12 to 05/15/17; J4AW7D, 37ER320, 06/18/12 to 05/15/17; J4AW7N, 37ER320, 06/18/12 to 05/15/17; J4AW86, 37ER320, 06/19/12 to 05/15/17; J4AX78, 37ER320, 06/23/12 to 05/15/17; J4AX7M, 37ER320, 06/23/12 to 05/15/17; J4AX84, 37ER320, 06/24/12 to 05/15/17; J4AX8M, 37ER320, 06/24/12 to 05/15/17; J4AY22, 37ER320, 06/26/12 to 05/15/17; J4AY23, 37ER320, 06/27/12 to 05/15/17; J4AY24, 37ER320, 06/27/12 to 05/15/17; J4AY26, 37ER320, 06/27/12 to 05/15/17; J4AY7E, 37ER320, 06/29/12 to 05/15/17; J4AY8R, 37ER320, 06/29/12 to 05/15/17; J4AY9D, 37ER320, 07/09/12 to 05/15/17; J4AZOL, 37ER320, 07/02/12 to 05/15/17; J4AZ1X, 37ER320, 07/11/12 to 05/15/17; J4AZ2H, 37ER320, 07/03/12 to 06/15/17; J4AZ6R, 37ER320, 07/06/12 to 06/15/17; J4AZ7K, 37ER320, 07/06/12 to 06/15/17; J4C04N, 37ER320, 07/11/12 to 06/15/17; J4C059, 37ER320, 07/12/12 to 06/15/17; J4C08U, 37ER320, 07/13/12 to 06/15/17; J4C09E, 37ER320, 07/14/12 to 06/15/17; J4C12Y, 37ER320, 07/16/12 to 06/15/17; J4C14F, 37ER320, 07/18/12 to 06/15/17; J4C16V, 37ER320, 07/18/12 to 06/15/17; J4C216, 37ER320, 07/23/12 to 06/15/17; J4C21H, 37ER320, 07/24/12 to 06/15/17; J4C21N, 37ER320, 07/24/12 to 06/15/17; J4C22M, 37ER320, 07/24/12 to 06/15/17; J4C30T, 37ER320, 07/27/12 to 06/15/17; J4C31J, 37ER320, 07/28/12 to 06/15/17; J4C32M, 37ER320, 08/21/12 to 06/15/17; J4C332, 37ER320, 07/30/12 to 06/15/17; J4C399, 37ER320, 08/03/12 to 06/15/17; J4C41U, 37ER320, 08/06/12 to 07/15/17; J4C42C, 37ER320, 08/04/12 to 07/15/17; J4C42X, 37ER320, 08/03/12 to 07/15/17; J4C45J, 37ER320, 08/07/12 to 07/15/17; J4C46Y, 37ER320, 08/07/12 to 07/15/17; J4C47A, 37ER320, 08/07/12 to 07/15/17; J4C489, 37ER320, 08/08/12 to 07/15/17; J4C49Y, 37ER320, 08/08/12 to 07/15/17; J4C508, 37ER320, 08/09/12 to 07/15/17; J4C510, 37ER320, 08/09/12 to 07/15/17; J4C57X, 37ER320, 08/14/12 to 07/15/17; J4C59E, 37ER320, 08/14/12 to 07/15/17; J4C606, 37ER320, 08/15/12 to 07/15/17; J4C65Z, 37ER320, 08/18/12 to 07/15/17; J4C66P, 37ER320, 08/20/12 to 07/15/17; J4C678, 37ER320, 08/21/12 to 07/15/17; J4C67K, 37ER320, 08/21/12 to 07/15/17; J4C762, 37ER320, 08/24/12 to 07/15/17; J4C765, 37ER320, 08/24/12 to 07/15/17; J4C76T, 37ER320, 08/24/12 to 07/15/17; J4C84K, 37ER320, 08/30/12 to 07/15/17; J4C84Z, 37ER320, 08/30/12 to 07/15/17; J4C90P, 37ER320, 09/05/12 to 07/15/17; J4C91H, 37ER320, 09/02/12 to 07/15/17; J4C91W, 37ER320, 09/05/12 to 07/15/17; J4C92P, 37ER320, 09/05/12 to 07/15/17; J4C96L, 37ER320, 09/06/12 to 08/15/17; J4C97D, 37ER320, 09/06/12 to 08/15/17; J4C97Z, 37ER320, 09/07/12 to 08/15/17; J4C98X, 37ER320, 09/07/12 to 08/15/17; J4CA3A, 37ER320, 09/11/12 to 08/15/17; J4CA4L, 37ER320, 09/11/12 to 08/15/17; J4CA62, 37ER320, 09/12/12 to 08/15/17; J4CA6K, 37ER320, 09/12/12 to 08/15/17; J4CA7F, 37ER320, 09/13/12 to 08/15/17; J4CA7J, 37ER320, 09/13/12 to 08/15/17; J4CA96, 37ER320, 09/13/12 to 08/15/17; J4CA9V, 37ER320, 09/13/12 to 08/15/17; J4CC63, 37ER320, 09/19/12 to 08/15/17; J4CD25, 42XBB48B 09/21/12 to 02/15/17; J4CD4R, 37ER320, 09/21/12 to 08/15/17; J4CD5H, 37ER320, 09/22/12 to 08/15/17; J4CD6D, 42XBB48B 09/25/12 to 02/15/17; J4CD6R, 37ER320, 09/25/12 to 08/15/17; J4CD8F, 42XBB48B 09/27/12 to 02/15/17; J4CE05, 37ER320, 09/26/12 to 08/15/17; J4CEOA, 37ER320, 09/26/12 to 08/15/17; J4CE1U, 37ER320, 09/26/12 to 08/15/17; J4CF6M, 37ER320, 10/05/12 to 09/15/17; J4CF6P, 37ER320, 10/05/12 to 09/15/17; J4CF7E, 37ER320, 10/05/12 to 09/15/17; J4CF7R, 37ER320, 10/06/12 to 09/15/17; J4CF80, 37ER320, 10/06/12 to 09/15/17; J4CF8X, 37ER320, 10/08/12 to 09/15/17; J4CGOP, 37ER320, 10/09/12 to 09/15/17; J4CG17, 37ER320, 10/10/12 to 09/15/17; J4CG1U, 37ER320, 10/10/12 to 09/15/17; J4CG2U, 37ER320, 10/10/12 to 09/15/17; J4CG37, 37ER320, 10/10/12 to 09/15/17; J4CG4L, 37ER320, 10/11/12 to 09/15/17; J4CG66, 37ER320, 10/11/12 to 09/15/17; J4CG8R, 37ER320, 10/16/12 to 09/15/17; J4CG8X, 37ER320, 10/16/12 to 09/15/17; J4CH10, 37ER320, 10/15/12 to 09/15/17; J4CH4U, 37ER320, 10/17;/12 to 09/15/17; J4CH4V, 37ER320, 11/16/12 to 09/15/17; J4CH97, 37ER320, 10/20/12 to 09/15/17; J4CH9R, 37ER320, 10/20/12 to 09/15/17; J4CJ17, 37ER320, 10/20/12 to 09/15/17; J4CJ61, 37ER320, 10/25/12 to 09/15/17; J4CJ6L, 37ER320, 10/25/12 to 09/15/17; J4CKOV, 37ER320, 10/27/12 to 09/15/17; J4CK16, 37ER320, 10/29/12 to 09/15/17; J4CK3L, 37ER320, 10/30/12 to 09/15/17; J4CK9D, 37ER320, 11/02/12 to 09/15/17; J4CK9J, 37ER320, 11/02/12 to 09/15/17; J4CL23, 37ER320, 11/03/12 to 10/15/17; J4CL3F, 37ER320, 11/06/12 to 10/15/17; J4CL3U, 37ER320, 11/06/12 to 10/15/17; J4CL49, 37ER320, 11/06/12 to 10/15/17; J4CL8D, 37ER320, 11/08/12 to 10/15/17; J4CL9A, 37ER320, 11/08/12 to 10/15/17; J4CL9Z, 37ER320, 11/17;/12 to 10/15/17; J4CN1C, 37ER320, 11/15/12 to 10/15/17; J4CN9T, 37ER320, 11/20/12 to 10/15/17; J4CP1P, 37ER320, 11/27/12 to 10/15/17; J4CP1Y, 37ER320, 11/27/12 to 10/15/17; J4CP4C, 37ER320, 11/27/12 to 10/15/17; J4CP4L, 37ER320, 11/27/12 to 10/15/17; J4CP8U, 37ER320, 11/29/12 to 10/15/17; J4CR1C, 37ER320, 11/30/12 to 10/15/17; J4CR3L, 37ER320, 12/04/12 to 10/15/17; J4CR44, 37ER320, 12/04/12 to 10/15/17; J4CR6Y, 37ER320, 12/04/12 to 11/15/17; J4CR7X, 37ER320, 12/07/12 to 11/15/17; J4CT1U, 37ER320, 12/07/12 to 11/15/17; J4CT27, 37ER320, 12/09/12 to 11/15/17; J4CTSR, 37ER320, 12/11/12 to 11/15/17; J4CU1U, 37ER320, 12/12/12 to 11/15/17; J4CU27, 37ER320, 12/12/12 to 11/15/17; J4CU3K, 37ER320, 12/14/12 to 11/15/17; J4CU68, 37ER320, 12/15/12 to 11/15/17; J4CV2F, 37ER320, 12/20/12 to 11/15/17; J4CV48, 37ER320, 12/20/12 to 11/15/17; J4CV4J, 37ER320, 12/21/12 to 11/15/17; J4CV4U, 37ER320, 12/21/12 to 11/15/17; J4CV58, 37ER320, 12/21/12 to 11/15/17; J9002K, 41XCB57S 01/03/12 to 12/15/16; J9002L, 41XCD52S 01/03/12 to 12/15/16; J9003P, 02CK017 01/05/12 to 12/31/99; J90058, 41XCC51S 01/06/12 to 12/15/16; J90078, 41XCDS15 01/05/12 to 12/15/16; J9012T, 41KNC61XL 01/06/12 to 12/15/16; J9012U, 41XCD50S 01/06/12 to 12/15/16; J9012V, 41FNC42XL, 01/06/12 to 12/15/16; J90143, 41XCB52S 01/09/12 to 12/15/16; J90145, 41XCB57S 01/09/12 to 12/15/16; J90146, 41FNC41XL 01/09/12 to 12/15/16; J9014N, 02CK017 01/06/12 to 12/31/99; J9016G, 41XCB52S 01/09/12 to 12/15/16; J9016H, 41FNC43XL 01/09/12 to 12/15/16; J9016J 41TNC49XL 01/10/12 to 12/15/16; J9016K 41KNC60XL 01/10/12 to 12/15/16; J9020X 41XCD51S 01/10/12 to 12/15/16; J9022W 02CK017 01/10/12 to 12/31/99; J90249 41KBC17XL 01/12/12 to 12/15/16; J9026C 41XCD51S 01/11/12 to 12/15/16; J9026D 41XCC51S 01/12/12 to 12/15/16; J9026H 02CK017 01/11/12 to 12/31/99; J9028G 41XCB57S 01/13/12 to 12/15/16; J9032A 41XCD50S 01/13/12 to 12/15/16; J9032D 41KBC17XL 01/13/12 to 12/15/16; J9033P 02CK017 01/13/12 to 12/31/99; J90379 41XCC51S 01/16/12 to 12/15/16; J9037A 41FNC42XL, 01/16/12 to 12/15/16; J9038A 41KBC17XL 01/17;/12 to 12/15/16; J90390 41KNC61XL 01/17;/12 to 12/15/16; J9042C 02CK017 01/17;/12 to 12/31/99; J9044R 41XCD51S 01/18/12 to 12/15/16; J9044T 41FNC42XL, 01/18/12 to 12/15/16; J9047G 41XCD51S 01/19/12 to 12/15/16; J9047H 41FNC41XL 01/19/12 to 12/15/16; J9051P 41XCD51S 01/20/12 to 12/15/16; J9051R 41XCC51S 01/20/12 to 12/15/16; J9051T 41XCC50S 01/20/12 to 12/15/16; J9051U 41FNC41XLD 01/20/12 to 12/15/16; J90574, 41XCB57S 01/23/12 to 12/15/16; J90575, 41TNC49XL 01/24/12 to 12/15/16; J90598, 41FNC42XL, 01/24/12 to 12/15/16; J9059A, 41XCD51S 01/25/12 to 12/15/16; J90643, 41XCD52S 01/26/12 to 12/15/16; J90644, 41KNC61XL 01/26/12 to 12/15/16; J90646, 41XCC53S 01/27/12 to 12/15/16; J9066Z, 41XCD51S 01/27/12 to 12/15/16; J90671, 41KNC60XL 01/27/12 to 12/15/16; J9068K, 02CK017 01/26/12 to 12/31/99; J90743, 41XCD51S 01/30/12 to 12/15/16; J9074T, 41TNC69XL 01/31/12 to 12/15/16; J9074X, 41FNC41XL 02/01/12 to 12/15/16; J90771, 41XCB52S, 01/31/12 to 12/15/16; J9080P, 41XCD51S, 02/01/12 to 12/15/16; J9080R, 41FNC42XL, 02/01/12 to 12/15/16; J90823, 41XCD52S, 02/01/12 to 12/15/16; J90824, 41XCC51S, 02/01/12 to 12/15/16; J90825, 41XCB57S, 02/01/12 to 12/15/16; J9082G, 02CK017, 02/01/12 to 12/31/99; J9084F, 41FNC43XL, 02/02/12 to 12/15/16; J90867, 41FNC41XL, 02/03/12 to 12/15/16; J90881, 41KNC09XL, 02/03/12 to 12/15/16; J90883, 41KNC60XL, 02/03/12 to 12/15/16; J9090A, 41XCD50S, 02/03/12 to 12/15/16; J9091Z, 02CK017, 02/03/12 to 12/31/99; J90931, 41XCD51S, 02/07/12 to 01/15/17; J90948, 41XCC53S, 02/07/12 to 01/15/17; J90949, 41TNC49XL, 02/07/12 to 01/15/17; J90968, 41FNC41XLD, 02/08/12 to 01/15/17; J90969, 41KNC07XL, 02/09/12 to 01/15/17; J9098C, 41TNC36XL, 02/09/12 to 01/15/17; J90993, 02CK017, 02/08/12 to 12/31/99; J90C1W, 41XCC51S, 02/14/12 to 01/15/17; J90C1X, 41XCD51S, 02/14/12 to 01/15/17; J90C1Y, 41XCD52S, 02/14/12 to 01/15/17; J90C1Z, 41XCC50S, 02/14/12 to 01/15/17; J90C67, 41XCD51S, 02/15/12 to 01/15/17; J90C8C, 02CK017, 02/15/12 to 12/31/99; J90DOL, 41XCD51S, 02/16/12 to 01/15/17; J9003N, 02CK017, 02/17/12 to 12/31/99; J9004Z, 41FNC43XL, 02/17/12 to 01/15/17; J90050, 41XCC51S, 02/17/12 to 01/15/17; J90051, 41FNC41XL, 02/17/12 to 01/15/17; J9007A, 41XCD51S, 02/17/12 to 01/15/17; J9008J, 41XCD51S, 02/21/12 to 01/15/17; J9008K, 41TNC36XL, 02/21/12 to 01/15/17; J9008L, 41KNC60XL, 02/21/12 to 01/15/17; J9009H, 41FNC41XLD, 02/20/12 to 01/15/17; J9009K, 02CK017, 02/20/12 to 12/31/99; J90E2R, 41XCD51S, 02/21/12 to 01/15/17; J90E2T, 41XCB57S, 02/21/12 to 01/15/17; J90E40, 41FNC42XL, 02/22/12 to 01/15/17; J90E5P, 41XCD51S, 02/22/12 to 01/15/17; J90E5T, 41XCB52S, 02/22/12 to 01/15/17; J90E7G, 41XCC53S, 02/22/12 to 01/15/17; J90E7R, 02CK017, 02/22/12 to 12/31/99; J90F03, 41XCD51S, 02/23/12 to 01/15/17; J90F06, 41XCD50S, 02/23/12 to 01/15/17; J90F2P, 41XCD515, 02/24/12 to 01/15/17; J90F2R, 41KBC17XL, 02/24/12 to 01/15/17; J90F2T, 41TNC69XL, 02/24/12 to 01/15/17; J90F2U, 41XCD525, 02/27/12 to 01/15/17; J90F4T, 41XCC515, 02/27/12 to 01/15/17; J90F68, 41XCD515, 02/27/12 to 01/15/17; J90F6A, 41KNC07XL, 02/27/12 to 01/15/17; J90F6C, 41FNC42XL, 02/27/12 to 01/15/17; J90F6U, 41FNC41XL, 02/27/12 to 01/15/17; J90F90, 41FNC41XLD, 02/28/12 to 01/15/17; J90F91, 41XCD515, 02/28/12 to 01/15/17; J90F9Z, 41KNC60XL, 02/28/12 to 01/15/17; J90GOO, 41KNC61XL, 02/28/12 to 01/15/17; J90GOF, 02CK017, 02/28/12 to 12/31/99; J90G23, 41XCD515, 02/29/12 to 01/15/17; J90G25, 41TNC36XL, 02/29/12 to 01/15/17; J90G26, 41XCC515, 02/29/12 to 01/15/17; J90G3A, 41KNC60XL, 02/29/12 to 01/15/17; J90G5F, 41XCD515, 03/01/12 to 01/15/17; J90G5H, 41FNC42XL, 03/01/12 to 01/15/17; J90G5J, 41XCD525, 03/01/12 to 01/15/17; J90G9G, 41XCB515, 03/02/12 to 01/15/17; J90G9H, 41KBC17XL, 03/02/12 to 01/15/17; J90G9J, 41XCC515, 03/02/12 to 01/15/17; J90G9K, 41TNC36XL, 03/02/12 to 01/15/17; J90HOP, 41TNC69XL, 03/05/12 to 01/15/17; J90H1R, 41XCD51S, 03/05/12 to 02/15/17; J90H6E, 41FNC42XL, 03/07/12 to 02/15/17; J90H6K, 41FNC41XL, 03/07/12 to 02/15/17; J90H6L, 41KBC17XL, 03/07/12 to 02/15/17; J90H7J, 41KNC09XL, 03/07/12 to 02/15/17; J90H7K, 41XCD525, 03/07/12 to 02/15/17; J90H7L, 41XCB575, 03/07/12 to 02/15/17; J90J1A, 02CK017, 03/07/12 to 12/31/99; J90J36, 41XCD51S, 03/09/12 to 02/15/17; J90J7X, 41XCC515, 03/09/12 to 02/15/17; J90J7Y, 41XCD525, 03/09/12 to 02/15/17; J90J7Z, 41FNC42XL, 03/09/12 to 02/15/17; J90J8P, 41FNC43XL, 03/12/12 to 02/15/17; J90KOH, 41XCD515, 03/12/12 to 02/15/17; J90KOJ, 41TNC20XL, 03/12/12 to 02/15/17; J90KOK, 41XCB575, 03/12/12 to 02/15/17; J90K1V, 41KNC60XL, 03/13/12 to 02/15/17; J90K4E, 41XCC505, 03/13/12 to 02/15/17; J90K4G, 41FNC41XL, 03/13/12 to 02/15/17; J90K4H, 41TNC49XL, 03/13/12 to 02/15/17; J90K4J, 41KNC07XL, 03/13/12 to 02/15/17; J90K5E, 41KNC61XL, 03/13/12 to 02/15/17; J90K5F, 41KNC09XL, 03/13/12 to 02/15/17; J90K6K, 02CK017, 03/13/12 to 12/31/99; J90K7N, 41FNC41XLD, 04/13/12 to 02/15/17; J90K7P, 41KNC09XL, 03/14/12 to 02/15/17; J90K7R, 41TNC49XL, 03/14/12 to 02/15/17; J90K7T, 41KNC07XL, 03/14/12 to 02/15/17; J90K9D, 41XCC51S, 03/14/12 to 02/15/17; J90L1A, 41FNC42XL, 03/15/12 to 02/15/17; J90L1D, 41XCD50S, 03/15/12 to 02/15/17; J90L1E, 41XCD52S, 03/15/12 to 02/15/17; J90L2L, 41FNC41XL, 03/15/12 to 02/15/17; J90L4E, 41KNC03XL, 03/16/12 to 02/15/17; J90L4F, 41KNC60XL, 03/16/12 to 02/15/17; J90L62, 41FNC43XL, 03/16/12 to 02/15/17; J90L6G, 02CK017, 03/16/12 to 12/31/99; J90M16, 02CK017, 03/19/12 to 12/31/99; J90M1T, 41FNC43XLD, 03/20/12 to 02/15/17; J90M1U, 41XCC51S, 03/20/12 to 02/15/17; J90M3G, 41FNC41XLD, 03/21/12 to 02/15/17; J90M3H, 41KNC19XL, 03/22/12 to 02/15/17; J90M3K, 41FNC42XL, 03/22/12 to 02/15/17; J90M4H, 41FNC41XL, 03/23/12 to 02/15/17; J90M4J, 41KNC60XL, 03/23/12 to 02/15/17; J90M50, 02CK017, 03/20/12 to 12/31/99; J90NOJ, 41KNC03XL, 03/23/12 to 02/15/17; J90NOK, 41FNC42XL, 03/23/12 to 02/15/17; J90N33, 41XCC51S 03/22/12 to 02/15/17; J90N4Y, 41XCC51S 03/27/12 to 02/15/17; J90P15, 41XCD51S 03/27/12 to 02/15/17; J90P16, 41FNC43XLD 03/27/12 to 02/15/17; J90P44, 41XCC51S 03/28/12 to 02/15/17; J90P5U, 02CK017 03/27/12 to 12/31/99; J90P6G, 02CK017 03/28/12 to 12/31/99; J90P7T, 41FNC42XL, 03/28/12 to 02/15/17; J90R22, 41KNC60XL 03/29/12 to 02/15/17; J90R23, 41FNC43XL 03/29/12 to 02/15/17; J90R24, 41XCC51S 03/29/12 to 02/15/17; J90R25, 41XCB52S 03/29/12 to 02/15/17; J90R3H, 41KNC07XL 03/29/12 to 02/15/17; J90R3J, 41FNC41XL 03/29/12 to 02/15/17; J90R45, 02CK017 03/29/12 to 12/31/99; J90T34, 41XCC51S 04/02/12 to 02/15/17; J90T35, 41KNC61XL 04/03/12 to 02/15/17; J90T3Z, 41XCB57S 04/02/12 to 02/15/17; J90T5D, 41XCC51S 04/04/12 to 03/15/17; J90T5E, 41XCB57S 04/04/12 to 03/15/17; J90T5F, 41FNC42XL, 04/04/12 to 03/15/17; J90T5G, 41FNC41XL 04/04/12 to 03/15/17; J90T90, 41KNC07XL 04/09/12 to 03/15/17; J90T91, 41XCB52S 04/09/12 to 03/15/17; J90T92, 41FNC43XL 04/09/12 to 03/15/17; J90T93, 41KNC61XL 04/09/12 to 03/15/17; J90UOT, 02CK017 04/04/12 to 12/31/99; J90U41, 41FNC41XLD 04/10/12 to 03/15/17; J90U50, 41FNC42XL, 04/10/12 to 03/15/17; J90U51, 41XCC51S 04/10/12 to 03/15/17; J90U52, 41KNC07XL 04/10/12 to 03/15/17; J90U53, 41FNC43XL 04/10/12 to 03/15/17; J90U54, 41TNC20XL 04/10/12 to 03/15/17; J90W98, 02CK017 04/10/12 to 12/31/99; J90X3A, 02CK017 04/11/12 to 12/31/99; J90X6K, 02CK017 04/12/12 to 12/31/99; J90X6X, 41FNC42XL, 04/12/12 to 03/15/17; J90X6Y, 41XCC51S 04/12/12 to 03/15/17; J90X7D, 41FNC41XL 04/12/12 to 03/15/17; J90X7K, 41KNC07XL 04/13/12 to 03/15/17; J90X9A, 41FNC43XL 04/13/12 to 03/15/17; J90VOO, 02CK017 04/13/12 to 12/31/99; J90V2U, 41XCD51S 04/17;/12 to 03/15/17; J90V41, 02CK017 04/16/12 to 12/31/99; J90V82, to 02CK017 04/17;/12 to 12/31/99; J90Z32, 41FNC42XL, 04/18/12 to 03/15/17; J90Z33, 41XCC51S 04/18/12 to 03/15/17; J90Z43, 41KBC17XL 04/19/12 to 03/15/17; J90Z44, 41XCD52S 04/18/12 to 03/15/17; J90Z5Z, 41FNC41XL, 04/19/12 to 03/15/17; J91005, 02CK017, 04/20/12 to 12/31/99; J9107X, 41FNC42XL, 04/24/12 to 03/15/17; J9110D, 41XCC51S, 04/25/12 to 03/15/17; J9110E, 41KBC17XL, 04/25/12 to 03/15/17; J9112K, 02CK017, 04/25/12 to 12/31/99; J91167, 41TNC49XL, 04/27/12 to 03/15/17; J91168, 41FNC41XL, 04/27/12 to 03/15/17; J91179, 02CK017, 04/26/12 to 12/31/99; J91195, 41XCD52S, 04/27/12 to 03/15/17; J9125D, 02CK017, 04/28/12 to 12/31/99; J9128G, 41FNC42XL, 05/02/12 to 03/15/17; J9128H, 41XCC51S, 05/02/12 to 03/15/17; J91306, 02CK017, 05/02/12 to 12/31/99; J9133G, 02CK017, 05/03/12 to 12/31/99; J9140G, 02CK017, 05/07/12 to 12/31/99; J91484, 02CK017, 05/09/12 to 12/31/99; J9167F, 02CK017, 05/17;/12 to 12/31/99; J91685, 41FNC41XL, 05/17/12 to 04/15/17; J9171F, 02CK017, 05/18/12 to 12/31/99; J9175D, 41XCC51S, 05/21/12 to 04/15/17; J9175F, 41KBC17XL, 05/21/12 to 04/15/17; J9180F, 41FNC42XL, 05/23/12 to 04/15/17; J9180G, 41KNC07XL, 05/23/12 to 04/15/17; J9181K, 02CK017, 05/22/12 to 12/31/99; J9183T, 41XCB52S, 05/23/12 to 04/15/17; J9183U, 41FNC43XL, 05/23/12 to 04/15/17; J9184V, 02CK017, 05/23/12 to 12/31/99; J9187R, 41KNC60XL, 05/25/12 to 04/15/17; J9196V, 41FNC43XLD, 05/28/12 to 04/15/17; J9196W, 41XCC51S, 06/15/12 to 04/15/17; J9196X, 41KNC07XL, 05/28/12 to 04/15/17; J9199X, 02CK017, 05/28/12 to 12/31/99; J91A1C, 41KBC17XL, 05/30/12 to 04/15/17; J91A1D, 41FNC42XL, 05/30/12 to 04/15/17; J91A1E, 41FNC43XL, 05/29/12 to 04/15/17; J91A47, 41FNC41XL, 05/30/12 to 04/15/17; J91A57, 41XCB52S, 05/30/12 to 04/15/17; J91A58, 41FNC41XLD, 05/30/12 to 04/15/17; J91A59, 41XCB57S, 05/30/12 to 04/15/17; J91A62, 41XCD52S, 05/30/12 -04/15/17; J91A63, 41TNC49XL, 05/31/12 to 04/15/17; J91A6V, 02CK017, 05/30/12 to 12/31/99; J91A9P, 02CK017, 05/31/12 to 12/31/99; J91C2H, 41KNC07XL, 06/01/12 to 04/15/17; J91C2Z, 41XCC51S, 06/04/12 to 04/15/17; J91C30, 41XCC51S, 06/01/12 to 04/15/17; J91C31, 41FNC42XL, 06/01/12 to 04/15/17; J91C3J, 41FNC43XL, 06/04/12 to 04/15/17; J91C3K, 41KBC17XL, 06/04/12 to 04/15/17; J91C60, 41FNC41XL, 06/05/12 to 04/15/17; J91C6Z, 02CK017, 06/04/12 to 12/31/99; J91D05, 41XCD51S, 06/05/12 to 05/15/17; J91D1D, 02CK017, , 06/05/12 to 12/31/99; J91D3V, 41KNC07XL, 06/06/12 to 05/15/17; J91D7X, 41XCB57S, 06/07/12 to 05/15/17; J91D7Y, 41FNC42XL, 06/07/12 to 05/15/17; J91D7Z, 41KNC07XL, 06/07/12 to 05/15/17; J91D8H, 41XCC51S, 06/08/12 to 05/15/17; J91D8J, 41TNC69XL, 06/07/12 to 05/15/17; J91E4M, 41XCD51S, 06/12/12 to 05/15/17; J91E4N, 41FNC41XLD, 06/12/12 to 05/15/17; J91E9R, 41FNC43XL, 06/13/12 to 05/15/17; J91E9T, 41FNC42XL, 06/12/12 to 05/15/17; J91E9V, 41KNC07XL, 06/13/12 to 05/15/17; J91F23, 02CK017, , 06/12/12 to 12/31/99; J91F45, 41XCB52S, 06/14/12 to 05/15/17; J91F47, 41TNC49XL, 06/14/12 to 05/15/17; J91F77, 41XBB79S, 06/14/12 to 05/15/17; J91F9F, 02CK017, , 06/14/12 to 12/31/99; J91G24, 41XCD51S, 06/14/12 to 05/15/17; J91G2D, 41KNC61XL, 06/20/12 to 05/15/17; J91G2Z, 02CK017, , 06/15/12 to 12/31/99; J91G5K, 41XCD51S, 06/15/12 to 05/15/17; J91G70, 41XCC51S, 06/18/12 to 05/15/17; J91H03, 41FNC42XL, 06/19/12 to 05/15/17; J91H04, 41KNC07XL, 06/21/12 to 05/15/17; J91H05, 41KBC17XL, 06/22/12 to 05/15/17; J91H15, 02CK017, , 06/19/12 to 12/31/99; J91H35, 41FNC41XL, 06/19/12 to 05/15/17; J91H36, 41XCD51S, 06/21/12 to 05/15/17; J91H9N, 02CK017, , 06/21/12 to 12/31/99; J91J39, 41KNC60XL, 06/22/12 to 05/15/17; J91K3F, 41XBB79S, 06/26/12 to 05/15/17; J91K5G, 41XBB79S, 06/26/12 to 05/15/17; J91K6V, 41XCC51S, 06/28/12 to 05/15/17; J91K6Z, 41KNC61XL, 07/04/12 to 05/15/17; J91K71, 41FNC42XL, 06/28/12 to 05/15/17; J91K73, 41XCC50S, 06/28/12 to 05/15/17; J91K75, 41KBC17XL, 06/29/12 to 05/15/17; J91L08, 41KNC61XL, 06/29/12 to 05/15/17; J91L09, 41FNC41XL, 06/29/12 to 05/15/17; J91LOA, 41XCB52S, 06/29/12 to 05/15/17; J91LOD, 41FNC43XL, 07/04/12 to 05/15/17; J91L68, 02CK017, , 06/29/12 to 12/31/99; J91MOH, 02CK017, , 07/04/12 to 12/31/99; J91M5Z, 41XBB79S, 07/05/12 to 06/15/17; J91M62, 41FNC43XLD, 07/05/12 to 06/15/17; J91M63, 41KBC17XL, 07/05/12 to 06/15/17; J91M6U, 02CK017, , 07/05/12 to 12/31/99; J91M9U, 41TNC49XL, 07/06/12 to 06/15/17; J91M9W, 41FNC41XL, 07/06/12 to 06/15/17; J91N3A, 41FNC41XLD, 07/09/12 to 06/15/17; J91N3C, 41XCB57S, 07/09/12 to 06/15/17; J91N3D, 41XCD52S, 07/09/12 to 06/15/17; J91N4K, 02CK017, , 07/09/12 to 12/31/99; J91N9L, 41FNC43XL, 07/10/12 to 06/15/17; J91N9M, 41XCB52S, 07/10/12 to 06/15/17;J91N9N, 41XCD51S, 07/10/12 to 06/15/17; J91P1K, 02CK017, , 07/10/12 to 12/31/99; J91P2X, 41KBC17Xl, 07/11/12 to 06/15/17; J91P2Y, 41XCC50S, 07/11/12 to 06/15/17; J91P2Z, 41XCC51S, 07/12/12 to 06/15/17; J91P47, 02CK017, , 07/11/12 to 12/31/99; J91P79, 41XCB52S, 07/12/12 to 06/15/17; J91P7A, 41FNC41Xl, 07/12/12 to 06/15/17; J91ROH, 41TNC36Xl, 07/13/12 to 06/15/17; J91ROK, 41FNC42Xl, 07/13/12 to 06/15/17; J91R4P, 41XCC53S, 07/17;/12 to 06/15/17; J91R4R, 41XCD51S, 07/17;/12 to 06/15/17; J91R9C, 41TNC49Xl, 07/17;/12 to 06/15/17; J91R9D, 41XCB57S, 07/18/12 to 06/15/17; J91R9F, 41FNC41Xl, 07/17;/12 to 06/15/17; J91T22, to 02CK017, , 07/17;/12 to 12/31/99; J91T42, 41XCD52S, 07/18/12 to 06/15/17; J91T67, 02CK017, , 07/18/12 to 12/31/99; J91T98, 41XCD50S, 07/19/12 to 06/15/17; J91T99, 41FNC42Xl, 07/19/12 to 06/15/17; J91T9A, 41XCC51S, 07/19/12 to 06/15/17; J91U23, 41XCD51S, 07/19/12 to 06/15/17; J91U36, 41KNC60Xl, 07/23/12 to 06/15/17; J91U37, 41KBC17Xl, 07/20/12 to 06/15/17; J91U38, 41XCC51S, 07/23/12 to 06/15/17; J91U46, 41TNC36Xl, 07/20/12 to 06/15/17; J91U7U, 41KNC09Xl, 07/24/12 to 06/15/17; J91U7V, 41XCC53S, 07/24/12 to 06/15/17; J91V2E, 41KNC03Xl, 07/25/12 to 06/15/17; J91V2F, 41XCD51S, 07/25/12 to 06/15/17; J91V30, 02CK017, , 07/24/12 to 12/31/99; J91V60, 41KBC17Xl, 07/25/12 to 06/15/17; J91V6U, 41XCC51S, 07/25/12 to 06/15/17; J91V6Z, 02CK017, , 07/25/12 to 12/31/99; J91W06, 41XCD51S, 07/26/12 to 06/15/17; J91W07, 41KNC60Xl, 07/27/12 to 06/15/17; J91W42, 41FNC43Xl, 07/27/12 to 06/15/17; J91W43, 41FNC41Xl, 07/27/12 to 06/15/17; J91W44, 41XCD52S, 07/27/12 to 06/15/17; J91W45, 41XCD51S, 07/27/12 to 06/15/17; J91W7J, 41XCC51S, 07/31/12 to 06/15/17; J91W7l, 41KBC17Xl, 07/30/12 to 06/15/17; J91W7M, 41KNC03Xl, 08/01/12 to 06/15/17; J91X1l, 02CK017, , 07/31/12 to 12/31/99; J91X3U, 41FNC42Xl, 08/01/12 to 06/15/17; J91X3V, 41FNC43XL, 08/01/12 to 06/15/17; J91X3W, 41FNC41XL, 08/02/12 to 06/15/17; J91X3X, 41FNC41XLD, 08/02/12 to 06/15/17; J91X7K, 41KNC60XL, 08/02/12 to 06/15/17; J91Y10, 41XCD51S, 08/03/12 to 07/15/17; J91Y11, 41XCC50S, 08/06/12 to 07/15/17; J91Y49, 41XCD51S, 08/06/12 to 07/15/17; J91Y5G, 02CK017, , 08/06/12 to 12/31/99; J91Y8A, 41TNC49XL, 08/07/12 to 07/15/17; J91Y8C, 41FNC42XL, 08/07/12 to 07/15/17; J91Y9C, 02CK017, , 08/08/12 to 12/31/99; J91Z1H, 41XCB57S, 08/08/12 to 07/15/17; J91Z1J, 41FNC41XL, 08/08/12 to 07/15/17; J91Z26, 41KBC17XL, 08/08/12 to 07/15/17; J91Z5J, 41FNC43XL, 08/09/12 to 07/15/17; J91Z9E, 41XCD51S, 08/13/12 to 07/15/17; J91Z9F, 41XCC51S, 08/14/12 to 07/15/17; J9206A, 41XCD51S, 08/15/12 to 07/15/17; J92079, 41XCD51S, 08/15/12 to 07/15/17; J9208E, 02CK017, , 08/15/12 to 12/31/99; J9210Y, 41XCC50S, 08/16/12 to 07/15/17; J9210Z, 41XCD50S, 08/16/12 to 07/15/17; J92110, 41XCD51S, 08/16/12 to 07/15/17; J9214G, 41XCC51S, 08/17;/12 to 07/15/17; J9214H, 41FNC41XL, 08/17;/12 to 07/15/17; J9214J, 41FNC42XL, 08/17;/12 to 07/15/17; J9214K, 41XCD51S, 08/17;/12 to 07/15/17; J9219P, 41FNC41XLD, 08/20/12 to 07/15/17; J92239, 41FNC43XL, 08/21/12 to 07/15/17; J9223A, 41KBC17XL, 08/21/12 to 07/15/17; J9223C, 41FNC43XLD, 08/21/12 to 07/15/17; J9223D, 41XCB52S, 08/21/12 to 07/15/17; J92245, 02CK017, , 08/21/12 to 12/31/99; J92273, 41XCD51S, 08/23/12 to 07/15/17; J92274, 41XCC51S, 08/22/12 to 07/15/17; J92275, 41FNC42XL, 08/23/12 to 07/15/17; J9230G, 41XCD51S, 08/24/12 to 07/15/17; J9231U, 02CK017, , 08/23/12 to 12/31/99; J9236P, 02CK017, , 08/24/12 to 12/31/99; J9237F, 41XCD51S, 08/27/12 to 07/15/17; J9243Y, 41FNC43XL, 08/28/12 to 07/15/17; J9243Z, 41FNC41XL, 08/28/12 to 07/15/17; J92440, 41XCC51S, 08/28/12 to 07/15/17; J92441, 41FNC41XLD, 08/28/12 to 07/15/17; J9244Y, 02CK017, , 08/28/12 to 12/31/99; J9247V, 41XCB55S, 08/29/12 to 07/15/17; J9247W, 41KBC17XL, 08/29/12 to 07/15/17; J9247X, 41XCC51S, 08/29/12 to 07/15/17; J9247Y, 41FNC41XL, 08/29/12 to 07/15/17; J9247Z, 41FNC43XL, 08/29/12 to 07/15/17; J9248W, 02CK017, , 08/30/12 to 12/31/99; J92578, 02CK017, , 08/31/12 to 12/31/99; J9260L, 02CK017, , 09/03/12 to 12/31/99; J9262H, 41FNC41XLD, 09/05/12 to 08/15/17; J9262J, 41XCC53S, 09/05/12 to 08/15/17; J9262K, 41FNC42XL, 09/04/12 to 08/15/17; J92639, 41XCC51S, 09/05/12 to 08/15/17; J9263A, 41XCB57S, 09/04/12 to 08/15/17; J92700, 41KBC17XL, 09/06/12 to 08/15/17; J92701, 41FNC43XL, 09/06/12 to 08/15/17; J92702, 41FNC42XL, 09/06/12 to 08/15/17; J9276X, 02CK017, , 09/07/12 to 12/31/99; J9277T, 41XCC51S, 09/10/12 to 08/15/17; J9277V, 41FNC43XL, 09/10/12 to 08/15/17; J9284L, 02CK017, , 09/11/12 to 12/31/99; J9284M, 41KNC60XL, 09/11/12 to 08/15/17; J92866, 41XCC50S, 09/12/12 to 08/15/17; J92868, 41FNC41XL, 09/12/12 to 08/15/17; J9289Y, 41TNC49XL, 09/13/12 to 08/15/17; J9289Z, 41FNC42XL, 09/13/12 to 08/15/17; J92900, 41FNC43XL, 09/13/12 to 08/15/17; J92902, 41XCC51S, 09/14/12 to 08/15/17; J9297F, 41XCC51S, 09/18/12 to 08/15/17; J9297H, 41XCB52S, 09/18/12 to 08/15/17; J92A2C, 41FNC41XL, 09/19/12 to 08/15/17; J92A2D, 41XCB52S, 09/19/12 to 08/15/17; J92A2E, 41XCC51S, 09/19/12 to 08/15/17; J92A2N, 02CK017, , 09/19/12 to 12/31/99; J92A50, 41FNC43XL, 09/20/12 to 08/15/17; J92A51, 41XCC53S, 09/20/12 to 08/15/17; J92A52, 41FNC42XL, 09/20/12 to 08/15/17; J92A53, 41FNC41XLD, 09/20/12 to 08/15/17; J92A7N, 02CK017, , 09/20/12 to 12/31/99; J92C1E, 02CK017, , 09/21/12 to 12/31/99; J92C5E, 41FNC43XLD, 09/27/12 to 08/15/17; J92C75, 02CK017, , 09/25/12 to 12/31/99; J92D7A, 41XCD52S, 09/28/12 to 08/15/17; J92EOO, 02CK017, , 09/28/12 to 12/31/99; J92E15, 41KBC17XL, 10/01/12 to 08/15/17; J92E42, to 02CK017, , 10/01/12 to 12/31/99; J92E5N, 41KNC60XL, 10/02/12 to 08/15/17; J92E5P, 41KNC61XL, 10/02/12 to 08/15/17; J92E5R, 41XCD51S, 10/02/12 to 08/15/17; J92E7J, 02CK017, , 10/02/12 to 12/31/99; J92F04, 41XCB57S, 10/04/12 to 09/15/17; J92F05, 41FNC43XL, 10/03/12 to 09/15/17; J92F06, 41FNC42XL, 10/04/12 to 09/15/17; J92F3G, 41KNC09XL, 10/04/12 to 09/15/17; J92F3H, 41FNC41XLD, 10/04/12 to 09/15/17; J92F73, 41FNC40XL, 10/08/12 to 09/15/17; J92F74, 41XCB57S, 10/08/12 to 09/15/17; J92F76, 41XCD51S, 10/08/12 to 09/15/17; J92GOO, 02CK017, , 10/05/12 to 12/31/99; J92G48, 02CK017, , 10/08/12 to 12/31/99; J92G5T, 41XCC50S, 10/09/12 to 09/15/17; J92G6G, 41KNC60XL, 10/09/12 to 09/15/17; J92G90, 41XCD51S, 10/12/12 to 09/15/17; J92G92, 41TNC49XL, 10/10/12 to 09/15/17; J92H03, 41FNC43XLD, 10/11/12 to 09/15/17; J92H20, 02CK017, , 10/10/12 to 12/31/99; J92H3C, 41XCD52S, 10/10/12 to 09/15/17; J92H3E, 41XCD50S, 10/12/12 to 09/15/17; J92H4E, 42KNC07XL, 10/11/12 to 09/15/17; J92H4Z, 42KNC35XL, 10/11/12 to 09/15/17; J92H50, 42XCB55S, 11/05/12 to 09/15/17; J92H6E, 02CK017, , 10/11/12 to 12/31/99; J92H6L, 41XCD50S, 10/11/12 to 09/15/17; J92H8J, 42XCB51S, 10/15/12 to 09/15/17; J92H8N, 41KBC17XL, 10/15/12 to 09/15/17; J92H8P, 41FNC41XL, 10/12/12 to 09/15/17; J92H8R, 41FNC42XL, 10/15/12 to 09/15/17; J92J2D, 41FNC41XLD, 10/16/12 to 09/15/17; J92J2F, 41TNC49XL, 10/16/12 to 09/15/17; J92J2H, 41FNC43XLD, 10/16/12 to 09/15/17; J92J32, 42KNC03XL, 10/16/12 to 09/15/17; J92J6N, 41XCD50S, 10/16/12 to 09/15/17; J92J6P, 41FNC41XL, 10/17;/12 to 09/15/17; J92J8W, 02CK017, , 10/16/12 to 12/31/99; J92K9A, 42KNC07XL, 11/05/12 to 09/15/17; J92K9C, 42XCB55S, 11/05/12 to 09/15/17; J92L9N, 02CK017, , 10/23/12 to 12/31/99; J92M19, 41XCC53S, 10/25/12 to 09/15/17; J92M4E, 02CK017, , 10/24/12 to 12/31/99; J92M6C, 41FNC41XLD, 10/25/12 to 09/15/17; J92M8K, 02CK017, , 10/25/12 to 12/31/99; J92N4R, 41FNC43XL, 10/30/12 to 09/15/17; J92N7Y, 42KNC35XL, 11/02/12 to 09/15/17; J92N7Z, 42KNC03XL, 11/05/12 to 09/15/17; J92N8Z, 02CK017, , 10/30/12 to 12/31/99; J92R3Y, 02CK017, , 11/02/12 to 12/31/99; J92T1A, 41FNC42XL, 11/06/12 to 10/15/17; J92T1C, 41KBC17XL, 11/06/12 to 10/15/17; J92T1D, 42KNC35XL, 11/06/12 to 10/15/17; J92T3A, 02CK017, , 11/06/12 to 12/31/99; J92T4G, 42KNC07XL, 11/07/12 to 10/15/17; J92T6M, 02CK017, , 11/07/12 to 12/31/99; J92T7E, 41XCC51S, 11/08/12 to 10/15/17; J92T7F, 41XCD52S, 11/08/12 to 10/15/17; J92T7G, 41XCB57S, 11/08/12 to 10/15/17; J92U06, 43TNC20XL, 11/12/12 to 10/15/17; J92U07, 43TNC69XL, 11/12/12 to 10/15/17; J92U26, 41KNC61XL, 11/14/12 to 10/15/17; J92U62, 42XCB55S, 11/14/12 to 10/15/17; J92U63, 42KNC03XL, 11/14/12 to 10/15/17; J92U88, 41KNC60XL, 11/14/12 to 10/15/17; J92V5U, 02CK017, , 11/14/12 to 12/31/99; J92V63, 41XCC51S, 11/15/12 to 10/15/17; J92V64, 41FNC41XLD, 11/15/12 to 10/15/17; J92V7H, 41FNC43XL, 11/14/12 to 10/15/17; J92V7K, 42XCB51S, 11/15/12 to 10/15/17; J92V8M, 43TNC20XL, 11/15/12 to 10/15/17; J92V8N, 43TNC69XL, 11/16/12 to 10/15/17; J92WOT, 02CK017, , 11/15/12 to 12/31/99; J92W2E, 43TNC69XL, 11/21/12 to 10/15/17; J92W2F, 43TNC20XL, 11/16/12 to 10/15/17; J92W2G, 43KNC03XL, 11/16/12 to 10/15/17; J92X07, 42KNC07XL, 11/21/12 to 10/15/17; J92XOA, 41FNC41XL, 11/22/12 to 10/15/17; J92XOC, 41XCC50S, 11/22/12 to 10/15/17; J92XOZ, 41FNC41XL, 11/21/12 to 10/15/17; J92X3P, 02CK017, , 11/22/12 to 12/31/99; J92X8C, 02CK017, , 11/24/12 to 12/31/99; J92X8D, 42KNC35XL, 11/23/12 to 10/15/17; J92X8E, 42XCB55S, 11/23/12 to 10/15/17; J92X9R, 41FNC43XL, 11/23/12 to 10/15/17; J92X9T, 41FNC42XL, 11/23/12 to 10/15/17; J92Y2P, 41KBC17XL, 11/26/12 to 10/15/17; J92Y2R, 41XCC50S, 11/26/12 to 10/15/17; J92Y2T, 41KNC61XL, 11/26/12 to 10/15/17; J92Y2U, 41XCC51S, 11/26/12 to 10/15/17; J92Y6R, 41XCD51S, 11/27/12 to 10/15/17; J92Y71, 41XCC51S, 11/28/12 to 10/15/17; J92ZOJ, 41FNC43XLD, 11/28/12 to 10/15/17; J92ZOK, 41KNC09XL, 11/28/12 to 10/15/17; J92Z14, 41XCD52S, 11/28/12 to 10/15/17; J92Z3Z, 02CK017, , 11/28/12 to 12/31/99; J92Z4R, 41XCB57S, 11/29/12 to 10/15/17; J92Z4T, 42XCB55S, 11/29/12 to 10/15/17; J92Z4U, 41XCC53S, 11/29/12 to 10/15/17; J92Z92, 41FNC41XL, 11/30/12 to 10/15/17; J92Z93, 41XCD51S, 12/01/12 to 10/15/17; J9302F, 41FNC42XL, 12/03/12 to 10/15/17; J9302G, 41KBC17XL, 12/03/12 to 10/15/17; J9302H, 41FNC43XL, 12/03/12 to 10/15/17; J9303L, 41XCC50S, 12/03/12 to 10/15/17; J93105, 41XCD51S, 12/05/12 to 11/15/17; J9313T, 41XCD52S, 12/05/12 to 11/15/17; J9313Z, 41XCC51S, 12/05/12 to 11/15/17; J93140, 41XCD50S, 12/07/12 to 11/15/17; J93168, 41XCD51S, 12/07/12 to 11/15/17; J9316C, 41FNC43XL, 12/10/12 to 11/15/17; J9316D, 41FNC42XL, 12/10/12 to 11/15/17; J9318Z, 02CK017, , 12/07/12 to 12/31/99; J93231, 02CK017, , 12/10/12 to 12/31/99; J9324T, 41KBC17XL, 12/10/12 to 11/15/17; J9324U, 41FNC40XL, 12/10/12 to 11/15/17; J9324V, 41XCC50S, 12/11/12 to 11/15/17; J9325M, 41FNC41XL, 12/11/12 to 11/15/17; K4C03G, 37ER320, 01/04/13 12/15/17; K4C03N, 37ER320, 01/04/13 12/15/17; K4C07P, 37ER320, 01/08/13 12/15/17; K4C09V, 37ER320, 01/09/13 12/15/17; K4C136, 37ER320, 01/10/13 12/15/17; K4C15P, 37ER320, 01/12/13 12/15/17; K4C16E, 37ER320, 01/12/13 12/15/17; K4C185, 37ER320, 01/13/13 12/15/17; K4C18P, 37ER320, 01/14/13 12/15/17; K4C18Y, 37ER320, 01/13/13 12/15/17; K4C19W, 37ER320, 01/15/13 12/15/17; K4C206, 37ER320, 01/16/13 12/15/17; K4C22M, 37ER320, 01/17;/13 12/15/17; K4C26W, 37ER320, 01/18/13 12/15/17; K4C27N, 37ER320, 01/21/13 12/15/17; K4C28T, 37ER320, 01/22/13 12/15/17; K4C293, 37ER320, 01/22/13 12/15/17; K4C31W, 37ER320, 01/22/13 12/15/17; K4C37N, 37ER320, 01/26/13 12/15/17; K4C384, 37ER320, 01/26/13 12/15/17; K4C39J, 37ER320, 01/25/13 12/15/17; K4C412, 37ER320, 01/26/13 12/15/17; K4C41Z, 37ER320, 01/26/13 12/15/17; K4C42N, 37ER320, 01/26/13 12/15/17; K4C504, 37ER320, 02/01/13 12/15/17; K4C51A, 37ER320, 02/02/13 12/15/17; K4C523, 37ER320, 02/02/13 12/15/17; K4C573, 37ER320, 02/06/13 01/15/18; K4C57K, 37ER320, 02/05/13 01/15/18; K4C581, 37ER320, 02/06/13 01/15/18; K4C58G, 37ER320, 02/06/13 01/15/18; K4C591, 37ER320, 02/06/13 01/15/18; K4C63E, 37ER320, 02/08/13 01/15/18; K4C645, 37ER320, 02/09/13 01/15/18; K4C64P, 37ER320, 02/12/13 01/15/18; K4C69N, 37ER320, 02/13/13 01/15/18; K4C709, 37ER320, 02/13/13 01/15/18; K4C71H, 37ER320, 02/13/13 01/15/18; K4C74T, 37ER320, 02/15/13 01/15/18; K4C791, 37ER320, 02/19/13 01/15/18; K4C82W, 37ER320, 02/20/13 01/15/18; K4C833, 37ER320, 02/20/13 01/15/18; K4C848, 37ER320, 02/21/13 01/15/18; K4C88J, 37ER320, 02/23/13 01/15/18; K4C88Y, 37ER320, 02/24/13 01/15/18; K4C89U, 37ER320, 02/24/13 01/15/18; K4C98D, 37ER320, 03/02/13 01/15/18; K4C98K, 37ER320, 03/01/13 01/15/18; K4CA38, 37ER320, 03/11/13 01/15/18; K4CA3V, 37ER320, 03/08/13 02/15/18; K4CC3F, 37ER320, 03/08/13 02/15/18; K4CC3H, 37ER320, 03/09/13 02/15/18; K4CC4R, 37ER320, 03/09/13 02/15/18; K4CC5J, 37ER320, 03/09/13 02/15/18; K4CC5K, 37ER320, 03/11/13 02/15/18; K4CD16, 37ER320, 03/13/13 02/15/18; K4CD1Y, 37ER320, 03/14/13 02/15/18; K4CD24, 37ER320, 03/14/13 02/15/18; K4CD2M, 37ER320, 03/14/13 02/15/18; K4CD3F, 37ER320, 03/15/13 02/15/18; K4CD3Y, 37ER320, 03/15/13 02/15/18; K4CD45, 37ER320, 03/15/13 02/15/18; K4CD7W, 37ER320, 03/18/13 02/15/18; K4CEOW, 37ER320, 03/20/13 02/15/18; K4CE2N, 37ER320, 03/20/13 02/15/18; K4CE9K, 37ER320, 03/23/13 02/15/18; K4CF07, 37ER320, 03/23/13 02/15/18; K4CFOJ, 37ER320, 03/26/13 02/15/18; K4CF43, 37ER320, 03/27/13 02/15/18; K4CF49, 37ER320, 03/27/13 02/15/18; K4CF60, 37ER320, 03/28/13 02/15/18; K4CF72, 37ER320, 03/28/13 02/15/18; K4CF7R, 37ER320, 03/28/13 02/15/18; K4CF8Z, 37ER320, 04/03/13 02/15/18; K4CG2H, 37ER320, 04/04/13 03/15/18; K4CG3H, 37ER320, 04/04/13 03/15/18; K90393, 41TNC49XL, 01/17;/13 12/15/17; K90394, 41FNC43XLD, 01/17;/13 12/15/17; K90395, 41FNC43XL, 01/17;/13 12/15/17; K9042A, 02CK017, , 01/18/13 12/31/99; K90441, 41FNC41XL, 01/21/13 12/15/17; K90442, 41KBC17XL, 01/21/13 12/15/17; K90443, 41FNC41XLD, 01/21/13 12/15/17; K90486, 41XCC51S, 01/22/13 12/15/17; K90487, 41XCD51S, 01/23/13 12/15/17; K90488, 41XCD52S, 01/23/13 12/15/17; K90489, 41XCB57S, 01/23/13 12/15/17; K90519, 02CK017, , 01/23/13 12/31/99; K9057D, 41TNC49XL, 02/01/13 12/15/17; K9059K, 02CK017, , 01/24/13 12/31/99; K9063J, 41FNC41XLD, 01/28/13 12/15/17; K9063K, 41FNC41XL, 01/28/13 12/15/17; K9083C, 41FNC43XL, 02/05/13 12/15/17; K9083D, 41XCC51S, 02/05/13 12/15/17; K9083E, 02CK017, , 02/01/13 12/31/99; K9084H, 41FNC42XL, 02/05/13 12/15/17; K9084L, 41XCB57S, 02/06/13 12/15/17; K9088P, 41FNC40XL 02/05/13 01/15/18; K9088R 41XCD52S 02/06/13 01/15/18; K90894 41XCB52S 02/06/13 01/15/18; K90895 41KBC17XL 02/06/13 01/15/18; K9093F 41XCD51S 02/07/13 01/15/18; K90947 43TNC69XL 02/08/13 01/15/18; K9094P 41FNC43XLD 02/11/13 01/15/18; K9097G 41XCD50S 02/12/13 01/15/18; K9097H 41XCD51S 02/11/13 01/15/18; K90A5Z, 43TNC69XL 02/13/13 01/15/18; K90A9V, 41FNC41XLD 02/13/13 01/15/18; K90A9W, 41FNC41XL, 02/13/13 01/15/18; K90A9X, 41XCC51S, 02/13/13 01/15/18; K90C2J, 02CK017, , 02/14/13 12/31/99; K90C3A, 41FNC43XL, 02/13/13 01/15/18; K90C3K, 41XCB57S, 02/14/13 01/15/18; K90C5C, 41XCD51S, 02/15/13 01/15/18; K90C89, 41XCD51S, 02/16/13 01/15/18; K90C8L, 41FNC43XLD, 02/15/13 01/15/18; K90C8N, 41XCD52S, 02/18/13 01/15/18; K90C9W, 02CK017, , 02/15/13 12/31/99; K90D1X, 41FNC42XL, 02/19/13 01/15/18; K90D1Y, 41KBC17XL, 02/19/13 01/15/18; K90D4U, 02CK01,7 02/18/13 12/31/99; K90D7N, 41XCC50S, 02/19/13 01/15/18; K90E1A, 41XCB57S, 02/20/13 01/15/18; K90E1D, 43TNC69XL, 02/20/13 01/15/18; K90E29, 41XCD50S, 02/20/13 01/15/18; K90E2A, 41XCB52S, 02/20/13 01/15/18; K90E4G, 02CK017, , 02/20/13 12/31/99; K90E5Y, 41XCD51S, 02/21/13 01/15/18; K90F02, 41FNC43XL, 02/22/13 01/15/18; K90F04, 41XCC51S, 02/22/13 01/15/18; K90F30, 02CK017, 02/23/13 to 12/31/99; K90F3X, 41XCD51S 02/22/13 01/15/18; K90F4E, 41XCD51S 02/25/13 01/15/18; K90F4H, 41FNC42XL, 02/25/13 01/15/18; K90F90 41FNC43XL 02/26/13 01/15/18; K90F91 41XCC51S 02/26/13 01/15/18; K90G1G 02CK017, 02/26/13 12/31/99; K90G2V 41FNC43XL 02/27/13 01/15/18; K90G2W 41FNC42XL, 02/27/13 01/15/18; K90G2X 41XCC51S 02/27/13 01/15/18; K90G4X 02CK017, 02/27/13 12/31/99; K90H1P 41KBC17XL 03/04/13 01/15/18; K90H1R 41XCD52S 03/04/13 01/15/18; K90H1T 41XCD51S 03/01/13 01/15/18; K90H5V 41FNC41XLD 03/04/13 01/15/18; K90JOZ 41KNC60XL 03/11/13 02/15/18; K90J10 41KNC61XL 03/07/13 02/15/18; K90J11 41TNC36XL 03/07/13 02/15/18; K90J93, 41XCC53S 03/07/13 02/15/18; K90K3, A 02CK017, 03/08/13 12/31/99; K90K55, 41KNC09XL 03/13/13 02/15/18; K90K56, 41FNC43XLD 03/12/13 02/15/18; K90K57, 41XCD51S 03/12/13 02/15/18; K90L08, 41FNC43XL 03/14/13 02/15/18; K90L09, 41KNC60XL 03/14/13 02/15/18; K90L17, 41FNC41XL 03/13/13 02/15/18; K90L1V, 02CK017, 03/12/13 12/31/99; K90L5A, 41KBC17XL 03/14/13 02/15/18; K90M20, 41XCD51S 03/14/13 02/15/18; K90M22, 41XCC53S 03/22/13 02/15/18; K90M3N, 41XCC50S 03/15/13 02/15/18; K90M3P, 41XCD50S 03/15/13 02/15/18; K90M6M, 41XCC51S 03/18/13 02/15/18; K90M6N, 41FNC43XL 03/18/13 02/15/18; K90M6P, 41XCD51S 03/18/13 02/15/18; K90N1Z, 41TNC49XL 03/19/13 02/15/18; K90N6A, 41XCB52S 03/20/13 02/15/18; K90N6C, 41FNC41XL 03/20/13 02/15/18; K90N9F, 41XCC51S 03/21/13 02/15/18; K90N9G, 41FNC43XL 03/21/13 02/15/18; K90N9H, 41FNC42XL, 03/21/13 02/15/18; K90P3G, 41TNC49XL 03/22/13 02/15/18; K90P3H, 41FNC41XLD 03/22/13 02/15/18; K90P4F, 41KNC61XL 03/22/13 02/15/18; K90R2P, 02CK017, 03/26/13 12/31/99; K90R8R, 41KBC17XL 04/01/13 02/15/18; K90R8T, 41FNC41XLD 04/01/13 02/15/18; K90U1H, 41TNC36XL 04/04/13 03/15/18; and K90U1J, 41KNC09XL 04/04/13 03/15/18. Class II Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP® 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation and feeding issues which may result in improper clip formation, vessel damage and/or insufficient occlusion of the vessel or other structure Ethicon Endo-Surgery Inc
Devices LIGACLIP® Endoscopic Rotating Multiple Clip Applier Convenience Kit (Flex Trays), 10mm M/L Product Usage: The LIGACLIP Endoscopic Rotating Multiple Clip Applier is a sterile, single patient use instrument designed to provide a means of ligation through ENDOPATH® surgical trocars. The instrument delivers 20 titanium clips that individually advance after each firing. The shaft is made of a low glare material that minimizes reflective distortion. It is designed to rotate 360° in either direction. The rotating knob is located to allow for a one-handed technique. FNC40XL, 41, 2017-09 to 2018-01; FNC41XL, 41, 2016-12 to 2018-02; FNC41XLD, 41, 2016-12 to 2018-02; FNC42XL, 41, 2016-12 to 2018-02; FNC43XL, 41, 2016-12 to 2018-02; FNC43XLD, 41, 2017-02 to 2018-02; KBC17XL, 41, 2016-12 to 2018-2; KNC03XL, 41, 2017-02 to 2017-06; KNC03XL, 42, 2017-09 to 2017-10; KNC03XL, 43, 2017-10; KNC07XL, 41, 2017-01 to 017-05; KNC07XL, 42, 2017-09 to 2017-10; KNC09XL, 41, 2016-12 to 2018-03; KNC19XL, 41, 2017-02; KNC60XL, 41, 2016-2 2018-02; KNC61XL, 41, 2016-12 to 2018-02; TNC20XL, 41, 2017-02 to 2017-03; TNC20XL, 43, 2017-10; TNC36XL, 41, 2017-01 to 2018-03; TNC49XL, 41, 2016-12 to 2018-02; TNC69XL, 41, 2016-12 to 2017-05; TNC69XL, 43, 2017-10 to 2018-1; XCB51S, 41, 2017-01; XCB51S, 42, 2017-09 to 2017-10; XCB52S, 41, 2016-12 to 2018-02; XCB55S, 41, 2017-07; XCB55S, 42, 2017-09 to 2017-10; XCB57S, 41, 2016-12 to 2018-01; XCC50S, 41, 2016-12 to 2018-02; XCC51S, 41, 2016-12 to 2018-02; XCC53S, 41, 2016-12 to 2018-02; XCD50S, 41, 2016-12 to 2018-02; XCD51S, 41, 2016-12 to 2018-02; XCD52S, 41, 2016-12 to 2018-01; KNC35XL, 42, 2017-09 to 2017-10; XBB48B, 41, 2016-07 to 2017-01; XBB48B, 42, 2017-02 and XBB79S, 41, 2017-05 to 2017-06. Class II Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP® 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation and feeding issues which may result in improper clip formation, vessel damage and/or insufficient occlusion of the vessel or other structure Ethicon Endo-Surgery Inc
Devices LIGACLIP® Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L, bulk non-sterile Product Usage: The LIGACLIP Endoscopic Rotating Multiple Clip Applier is a single patient use instrument designed to provide a means of ligation through ENDOPATH® surgical trocars. The instrument delivers 20 titanium clips that individually advance after each firing. The shaft is made of a low glare material that minimizes reflective distortion. It is designed to rotate 360° in either direction. The rotating knob is located to allow for a one-handed technique. CK017, 02, 2016-11 to 2018-03 Class II Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP® 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation and feeding issues which may result in improper clip formation, vessel damage and/or insufficient occlusion of the vessel or other structure Ethicon Endo-Surgery Inc
Biologics Red Blood Cells Leukocytes Reduced Irradiated W127813300875; Class II Blood product, which was irradiated but labeled with incorrect irradiation status and expiration date, was distributed. Tacoma Pierce County Blood Bank
Biologics Red Blood Cells Leukocytes Reduced W038112210948; W038112124166; Class II Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. OneBlood, Inc.
Biologics Platelets Pooled Leukocytes Reduced W038112985393; W038112982318; Class II Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. OneBlood, Inc.
Biologics Blood and Blood Products for Reprocessing W038111360397; Class II Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. OneBlood, Inc.
Biologics Red Blood Cells Leukocytes Reduced 006LJ61025 Class II Blood product, collected from an ineligible donor, was distributed. American National Red Cross The
Biologics Blood and Blood Products for Reprocessing 006LJ61025 Class II Blood product, collected from an ineligible donor, was distributed. American National Red Cross The
Biologics Red Blood Cells Leukocytes Reduced W069111115072 Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Mississippi Blood Services Inc.
Biologics Platelets Pheresis Leukocytes Reduced W037913559084(Part A); W037913559084(Part B) Class II Blood products, in which quality control and distribution of products did not meet specifications, were distributed. LifeServe Blood Center
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W035212218081F(Part A); W035212218081F(Part B) Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Carter BloodCare/ WE & Lela I Stewart Blood Center, Inc
Biologics Blood and Blood Products for Reprocessing W035413009699 Class III Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. Community Blood Center
Drugs Pharmalucence Kit for the Preparation of Technetium Tc 99m Sestamibi Injection for Mycardial and Breast Imaging. For Intravenous Use and Reconstitution. a) Five vials kits: NDC# 45567-0555-1, b) Thirty vials kits: NDC# 45567-0555-2, Rx Only, Manufactured by: Pharmalucence, Inc., Billerica, MA 01821 Lot 280011, Exp 08/13 Class III Presence of Particulates; particulate found in retain sample Pharmalucence, Inc.
Devices TotalCare Bed used with AccuMax Quantum VPC mattress AccuMax Quantum Complete mattress, and AccuMax Quantum Convertible mattress The TotalCare Bed System is intended to provide a patient support ideally suited to be used in health care environments. The TotalCare Bed System may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The TotalCare Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution. Bed model numbers: PAU001010784, PAU005010784, P1900, PAK169N10184, PAK169N10384, PA8171210184, PA8175210184, PA8175210384, PA8171210384, PA8171310384, and PA8173210384. The AccuMax Quantum VPC, Complete and Convertible mattresses are not serialized, but were distributed between September 2005 and April 2013 Class II Hill-Rom is initiating this recall due to a potential issue with TotalCare® Beds equipped with AccuMax Quantum" mattresses. If the bed is put into the chair egress position, the magnets on the mattress may not hold the bottom of the mattress flat to the bed frame. If this happens, the foot section of the mattress will extend away from the bed at about a 30° angle (as shown in the photo). A patient attempting to get back into the bed may assume that the mattress is against the bed and attempt to sit, but may miss the seat and sit on the foot section instead. This can result in the patient sliding down to the floor, with possible injury. If the patient falls, the result may be major critical muscular/skeletal injury. Hill-Rom, Inc.
Devices Advanced Orthogonal Percussion Adjusting Instrument Indicated for use by a licensed Chiropractor to assist in making Chiropractic adjustments to the Atlas vertebra. Serial numbers: 001, 002, 008, 007, 006, 0010, 009, 011, 016, 015, 014, 023, 017, 018, 019, 020, 021, 024, 025, 022, 027, 026, 028, 029, 030, 031, 032, 033, 034, 035, 036, 038, 039, 037, 041, 042, 040, 043, 044, 045, 046, 048, 049, 050, 052, 053, 055, 056, 060, 058, 059, and 061 Class II Unapproved medical device Advanced Orthogonal Equipment, Incorporated
Devices HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy. Part Number applies to all: 0020002950 - all product lots. Lot Numbers: 1) N0716706 Exp. Date 5/31/2013, 2) N0817321 Exp. Date 5/31/2013, 3) E0917396 Exp. Date 9/30/2013, 4)) N0917378 Exp. Date 9/30/2013, 5) N1118029 Exp. Date 10/31/2013, 6) N0128669 Exp. Date 1/31/2014, 7) N0329291 Exp. Date 2/28/2014, 8) N0429596 Exp. Date 3/31/2014, 9) N0520056 Exp. Date 5/31/2014,10) E0720822 Exp. Date 7/31/2014, 11) N0821174 Exp. Date 8/31/2014, 12) N091388 Exp. Date 9/30/2014, 13) N0921522 Exp. Date 9/30/2014, 14) N0132676 Exp. Date 1/31/2015 and 15) N1222567 Exp. Date 1/31/2015. Class II Instrumentation Laboratory is recalling HemosIL RecombiPlasTin 2G (RPT2G), Part No. 0020009580 (8 mL Size) due to being Out of Specification. Instrumentation Laboratory Co.
Devices Swift Mobil shower chair, Swift Mobil 160 shower chair, and Swift Mobil Tilt shower chair. Height adjustable four wheeled shower chairs for persons of various weights. Affected Serial numbers: 3829 to 11028 (same series for all Swift Mobil products) Class II Etac is voluntarily conducting a field correction of the Etac Swift Mobil shower chair. If the Swift Mobil shower chair loses a caster and thus becomes instantly unstable, there is potiential risk for harm or injury. Etac Supply Center Ab
Drugs West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10), b) 5000-count bottle (NDC 0143-1140-51), Rx only, Manufactured by West-ward Pharmacuetical Corp., Eatontown, N.J., 07724 Lot # 69098A, 69098B, 69100A; Exp 8/15 Class II Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets. West-Ward Pharmaceutical Corp.
Drugs West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10),Rx only, Manufactured by West-ward Pharmacuetical Corp., Eatontown, N.J., 07724 Lot# 67331A, Exp 10/14 Class II Cross contamination with other products: Belladonna Alkaloids with Phenobarbital Tablets contained a trace amount of Methocarbamol. West-Ward Pharmaceutical Corp.
Food Vanilla almond granola, Net WT 16 oz(454g), UPC 0 71725 71239 4, Distributed by American Importing Co., Inc, Minneapolis, MN 55414. Vanilla Almond Granola, Net Wt 16 oz (454g), UPC 7 25439 20038 7, Distributed by DZA Brands LLC, Salisbury,NC 28147. Hy-Vee Granola Vanilla Almond, 24 oz, UPC 71725 71239 Amport, Granola, Vanilla Almond, 22 oz, UPC 71725 72512 8/10/13 223X218 9/13/13 257X218 4/16/13 1072O3 5/14/13 1352O2 7/12/13 1942P2 or 1942O2 8/10/13 223X218 9/13/13 257X218 11/4/2013 353385819 12/12/13 0722D1 1/24/2013 1142-362329 1/23/2013 1142-362331 1/24/2013 1152-363511 2/1/2013 1222-364253 2/7/2013 1282-364381 2/24/2013 1452-366291 3/7/2013 1592-366870 6/7/2013 2512-374976 6/13/2013 2572-374410 6/13/2013 2572-375613 7/1/2013 2752-376949 7/7/2013 2912-376014 7/17/2013 2912-378591 7/17/2013 2912-378591 8/5/2013 3102-379574 8/6/2013 3112-379952 9/12/2013 3472-382323 9/13/2013 3472-382969 4/16/13 1072O3 5/14/13 1352O2 8/10/13 223X218 9/13/13 257X218 1/22/14 022X318 5/14/13 1352O2 8/10/13 223X218 9/13/13 257X218 1/22/14 022X318 4/16/13 1072O3 8/10/13 223x218 9/13/13 257x218 8/15/13 320X246 4/16/13 1072O3 8/10/13 233X218 9/13/13 257X218 1/22/14 022X318 5/14/13 1352O2 7/12/13 1942P2 or 1942O2 8/10/13 223X218 9/13/18 257X218 4/16/13 1072O3 3/6/13 0662O2 4/16/13 1072P3 5/14/13 1352OO1 6/6/13 1582I1 8/1/13 214X218 8/10/13 233X218 9/13/13 257X218 10/8/13 282X218 10/30/13 304X218 11/15/13 320X218 1/24/2013 1142-362329 1/24/2013 1152-363511 2/1/2013 1222-363918 3/7/2013 1592-366870 6/13/2013 2572-374410 6/13/2013 2572-375613 7/17/2013 2912-376014 8/6/2012 3112-379952 1/23/2013 1142-362331 1/24/2013 1142-362329 2/1/2013 1222-363918 2/7/2013 1282-364381 3/7/2013 1592-366870 6/7/2013 2512-372839 6/13/2013 2572-374410 6/13/2013 2572-375613 7/1/2013 2752-376665 7/17/2013 2912-376014 7/17/2013 2912-378591 8/5/2013 3102-379574 8/6/2013 3112-379952 9/13/2013 3472-382969 11/4/2013 0353-385819 5/14/13 1352N2 6/7/2013 2512-372839 6/13/2013 2572-374410 7/1/2013 2752-376665 7/1/2013 2752-376949 7/17/2013 2912-376014 9/13/2013 3472-382969 9/13/13 257X218 Class II American Importing Co., d/b/a Amport Foods is voluntarily recalling a limited number of packages of its Amport Foods 16 oz Vanilla Almond Granola because they may contain pliable metal wire mesh fragments from a defective flour sifter from a 3rd party vendor. American Importing Co, Inc
Food Orchard Reserve, Fiber Health Blend, Net WT 6.5 oz , UPC 0 71725 74211 7, Distributed by Amport Foods, Minneapolis, MN 55414. Best By 1/28/14 Lot #:30X322 Class II American Importing Co., d/b/a Amport Foods is voluntarily recalling a limited number of packages of its Amport Foods 16 oz Vanilla Almond Granola because they may contain pliable metal wire mesh fragments from a defective flour sifter from a 3rd party vendor. American Importing Co, Inc
Food Smart Sense Fruit & Granola Trail Mix, Net WT 4.0 oz , UPC 8 83967 29091 8, Distributed by Kmart corporation, Hoffman Estates, Il 60179, Minneapolis, MN 55414. Lot # Best By Date 9/10/2012 7/10/2013 10/16/2012 8/16/2013 10/23/2012 8/23/2013 11/5/2012 9/5/2013 12/3/2012 10/3/2013 1/3/2013 11/3/2013 1/4/2013 11/4/2013 1/22/2013 11/22/2013 Class II American Importing Co., d/b/a Amport Foods is voluntarily recalling a limited number of packages of its Amport Foods 16 oz Vanilla Almond Granola because they may contain pliable metal wire mesh fragments from a defective flour sifter from a 3rd party vendor. American Importing Co, Inc
Biologics Blood Bank software Primary Application with Model numbers 5.4.0.2 and 5.4.1. BBCS Primary Application 5.4.0.2, 5.4.1 Class II Blood Bank software Primary Application (Model Numbers 5.4.0.2 and 5.4.1), with a defect or glitch, was distributed. Blood Bank Computer Systems, Inc
Biologics BDTM Stem Cell Control Kit; BD Biosciences 2350 Qume Drive, San Jose, CA 95131 Catalog number: 340991 Lot numbers: BC053, expires 06/02/13 and BC063, expires 07/02/13. Class II BD Stem cells controls, not functioning as intended, were distributed. BD Biosciences, Systems & Reagents
Devices Philips HeartStart MRx Monitor/Defibrillator, Model numbers M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician Serial numbers ranging from: US00100100 to US00567299 (serial numbers of the HeartStart MRx monitor/defibrillator are printed on the primary label on the back of the MRx in battery bay B) Class II The MRx may deliver a non-synchronized cardioversion shock resulting in the delivery of incorrect therapy, which may induce ventricular fibrillation. Philips Healthcare Inc.
Devices Dermalight 80 Model Number UVB-080, one unit per box. The Dermalight 80 is a Phototherapy light unit that provides ultraviolet radiation therapy for diagnosed skin disorders such as Psoriasis and Vitiligo. The following batch numbers and serial numbers are affected by this recall: Batches 7839 and 7951, Serial numbers D80-12748 to D80-12871. Class III The incorrect manual may have been packaged with this product. UVB-080 devices may have included the manual for a UVA-083 device. National Biological Corp
Devices Dermalight 80 Model Number UVB-083, one unit per box. The Dermalight 80 is a Phototherapy light unit that provides ultraviolet radiation therapy for diagnosed skin disorders such as Psoriasis and Vitiligo. The following batch and serial numbers are affected by the recall: Batch 007778, Serial numbers D83-30016 to D83-30021. Class III The incorrect manual may have been packaged with this product. UVB-083 devices may have included the manual for a UVA-080 device. National Biological Corp
Drugs AmBisome (amphotericin B) liposome for injection, 50mg vial, single use vial, For Intravenous Infusion Only, Rx Only, Marketed by: Astellas Pharma US, Inc., Northbrook, IL 60062, Manufactured by: Gilead Sciences, Inc, San Dimas, CA 91773, NDC: 0469-3051-30. Lot #: 042267AA, Exp July 2015, 042287AA, 042289AA, 042291AA, Exp Aug 2015. Lot Numbers and Expiry Dates (for Canada distribution). LOT 042269AA, EXP 07/2015, LOT 0422C1AA, EXP 11/2015. Class II Lack of Assurance of Sterility; Astellas Pharma US, Inc. is performing a voluntary recall on certain lots of AmBisome because the manufacturer has notified Astellas that during a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in the media fills. Astellas Pharma US Inc
Devices Endopath Electrosurgery Probe Plus II, twelve (12) different devices, including hooks, spatulas, right angles, curved dissectors, suction/irrigation devices, accessory ports, pool/sump devices and stone retrieval cannula, packaged and sterilized individually in a transparent flexible blister sealed to a Tyvek lid. 6 flexible packages are placed into a sales unit carton, with 4 cartons per corrugated shipper. The Endopath Electrosurgery Probe Plus II system has application in minimally invasive procedures to facilitate tissue dissection, coagulation, irrigation, and fluid evacuation through a common trocar sleeve. Product Code: EPS01, Exp. Date: 2015 09 through 2018 03; Product Code: EPS02, Exp. Date: 2015 09 through 2018 03; Product Code: EPS03, Exp. Date: 2015 09 through 2018 03; Product Code: EPS04, Exp. Date: 2015 09 through 2018 03; Product Code: EPS05, Exp. Date: 2015 09 through 2018 03; Product Code: EPS06, Exp. Date: 2015 09 through 2018 03; Product Code: EPS07, Exp. Date: 2015 09 through 2018 03; Product Code: EPS08, Exp. Date: 2015 09 through 2018 03; Product Code: EPS10, Exp. Date: 2013 04 through 2018 03; Product Code: EPS11, Exp. Date: 2013 04 through 2018 03; Product Code: EPS12, Exp. Date: 2013 04 through 2018 03 & Product Code: EPS13, Exp. Date: 2013 04 through 2018 03. Class II The firm is recalling the ENDOPATH Probe Plus II Shafts because the possibility that a tear in the Tyvek packaging may affect the sterility of the device. Ethicon Endo-Surgery Inc
Drugs Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, 60-count bottle, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60 Lot 635098A, Exp 10/14 Class II Failed Tablet/Capsule Specifications: Broken tablets Watson Laboratories, Inc.-(Actavis) - Florida
Devices Myoscience brand iovera Smart Tip, Myoscience Cryo-Touch IV, a Cryogenic Surgical device, REF Catalog Number: STA0311-10. Product Usage: The Myoscience Cryo-Touch IV (a.k.a. iovera) is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. The Cryo-Touch IV (a.k.a. iovera) is not indicated for treatment of central nervous system tissue. Serial Numbers: 100100, 100101, 100103 Class II The outer box label of the product was labeled with a down revision label which did not include the US labeling requirements, specifically the symbol descriptors and also the "Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician." This product was previously labeled for EU distribution only. Myoscience Inc
Food 601009 ANTIOXIDANT SUPERSTAR MIX 100/2 OZ FLAT PACK, UPC 2052601009 601076 ANTIOXIDANT SUPERSTAR MIX 12/6 OZ BERGIN RED BAG, UPC 2052601076 601051 ANTIOXIDANT SUPERSTAR MIX 12/8 OZ CLAMSHELL, UPC 2052601051 601051.03 ANTIOXIDANT SUPERSTAR MIX 12/8 OZ CLAMSHELL KOWALSKI, UPC 2052601051 601049.01 ANTIOXIDANT SUPERSTAR MIX 16/6 OZ CLAMSHELL, UPC 1115099870 601049.1 ANTIOXIDANT SUPERSTAR MIX 16/6 OZ CLAMSHELL CUB, IUPAC 601070 ANTIOXIDANT SUPERSTAR MIX 3/5#, UPC 2052601070 601050 ANTIOXIDANT SUPERSTAR MIX 30#, UPC 2052601050 601052 ANTIOXIDANT SUPERSTAR MIX 5#, UPC 2052601052 601069 ANTIOXIDANT SUPERSTAR MIX 8/10 OZ SQ TUB, UPC 2052601069 601069.05 ANTIOXIDANT SUPERSTAR MIX 8/10 OZ SQ TUB FESTIVAL, UPC 2052601069 601054 ANTIOXIDANT SUPERSTAR MX 12/10 OZ BAGLINE, UPC 2052601054 601069.04 ANTIOXIDANT SUPERSTAR MIX 8/10 OZ SQ TUB BOULDER, IUPAC 601048.00 ANTIOXIDANT SUPERSTAR MIX 100/2 OZ FLAT PACK PROMOTIONAL ANTIOXIDANT SUPERSTAR MIX***, UPC 2052601048. 601049.00 ANTIOXIDANT SUPERSTAR MIX 16/6 OZ CLAMSHELL SUPER ANTIOXIDANT MIX***, UPC 2052601049 612150.03 LARGE GIFT BOX KOWALSKIS, UPC 2052612150. Best By 6/22/2013, 10/6/2013, 10/10/2013,10/30/2013, 12/29/2013, 1/8/2014, 1/12/2014, 2/1/14, 2/2/2014, 1/26/2014, 1/28/2014. Class I Bergin Fruit and Nut Company is initiating a recall on a number of pistachio products manufacturing using pistachios supplied by ARO Pistachio Company. The recall was initiated because Salmonella was found in the environment at the ARO Pistachio Company. Bergin Fruit And Nut Co Inc
Food 601041 HEALTHY HEART MIX 12/14 OZ TRAY, UPC 2052601041 601078 HEALTHY HEART MIX 12/8 OZ CLAMSHELL, UPC 2052601078 601078.03 HEALTHY HEART MIX 12/8 OZ CLAMSHELL KOWALSKI, UPC 2052601078 601089 HEALTHY HEART MIX 16/6 OZ CLAMSHELL, UPC 2052601089 601089.1 HEALTHY HEART MIX 16/6 OZ CLAMSHELL CUB, UPC 1115099868 601125 HEALTHY HEART MIX 8/10 OZ SQ TUB, UPC 2052601125 601125.04 HEALTHY HEART MIX 8/10 OZ SQ TUB BOULDER, UPC 2052601125 601125.05 HEALTHY HEART MIX 8/10 OZ SQ TUB FESTIVAL, UPC 2052601125 601063 HEALTHY HEART NUT MIX 12/16 OZ BAGLINE, UPC 2052601063 601061.05 HEALTHY HEART NUT MIX 12/16 OZ FESTIVAL, UPC 2052601061 601037 HEALTHY HEART NUT MIX 30#, UPC 2052601037 601038 HEALTHY HEART NUT MIX 5#, UPC 2052601038 601089.01 HEALTHY HEART MIX 16/6 OZ CLAMSHELL, UPC 1115099868 602037 HEALTHY HEART NUT MIX 2/5#, UPC 2052602037 601137.00 HEALTHY HEART MIX 12/7 OZ BERGIN CUSTOM ZIPLOCK POUCH DISCONTINUED HEALTHY HEART MIX***, UPC 2052601137 Best By: 11/20/2013, 12/11/2013, 11/23/2013, 1/28/2014, 1/11/2014, 1/12/2014, 1/18/2014, 1/21/2014, 1/22/2014, 1/29/2014, 2/2/2014. Class I Bergin Fruit and Nut Company is initiating a recall on a number of pistachio products manufactured using pistachios supplied by ARO Pistachio Inc. Salmonella was found in the environment at the ARO Pistachio Inc. company. Bergin Fruit And Nut Co Inc
Food 604320 LOW GLYCEMIC INSTANT OATMEAL 25#, UPC 2052604320 Best By: 12/4/2013 Class I Bergin Fruit and Nut Company is initiating a recall on a number of pistachio products manufactured using pistachios supplied by ARO Pistachio Inc. Salmonella was found in the environment at the ARO Pistachio Inc. company. Bergin Fruit And Nut Co Inc
Food 601180 LOW GLYCEMIC SNACK MIX 12/4 OZ BERGIN RED BAG, UPC 2052601180 601082 LOW GLYCEMIC SNACK MIX 12/8 CLAMSHELL, UPC 2052601082 601082.03 LOW GLYCEMIC SNACK MIX 12/8 CLAMSHELL KOWALSKI, UPC 2052601082 601080 LOW GLYCEMIC SNACK MIX 30#, UPC 2052601080 601084 LOW GLYCEMIC SNACK MIX 5#, UPC 2052601084 601083.04 LOW GLYCEMIC SNACK MIX 8/10 OZ SQ TUB, UPC 2052601083 601083 LOW GLYCEMIC SNACK MIX 8/10 OZ SQ TUB, UPC 2052601083 10/6/2013, 11/27/2013, 12/31/2013, 1/18/2014, 1/27/2014, 1/28/2014. Class I Bergin Fruit and Nut Company is initiating a recall on a number of pistachio products manufactured using pistachios supplied by ARO Pistachio Inc. Salmonella was found in the environment at the ARO Pistachio Inc. company. Bergin Fruit And Nut Co Inc
Food 604293 MEGA OMEGA MIX 12/8 OZ SQ TUB, UPC 2052604293 604293.04 MEGA OMEGA MIX 12/8 OZ SQ TUB BOULDER, UPC 2052604293 604293.05 MEGA OMEGA MIX 12/8 OZ SQ TUB FESTIVAL, UPC 2052604293 604290 MEGA OMEGA MIX 15#, UPC 2052604290 604292 MEGA OMEGA MIX 16/7 OZ - CLAMSHELL,UPC 2052604292 604291 MEGA OMEGA MIX 5#, UPC 2052604291 11/26/13, 1/11/2014, 1/19/2014,1/11/2014, 1/22/2014, 1/28/2014, 1/29/2014. Class I Bergin Fruit and Nut Company is initiating a recall on a number of pistachio products manufactured using pistachios supplied by ARO Pistachio Inc. Salmonella was found in the environment at the ARO Pistachio Inc. company. Bergin Fruit And Nut Co Inc
Food 601911 PISTACHIO KERNELS HOT & SPICY 30#, UPC 2052601911 601913 PISTACHIOS HOT AND SPICY 12/5 OZ BERGIN RED BAG, UPC 2052601913 5/24/2014, 5/28/2014. Class I Bergin Fruit and Nut Company is initiating a recall on a number of pistachio products manufactured using pistachios supplied by ARO Pistachio Inc. Salmonella was found in the environment at the ARO Pistachio Inc. company. Bergin Fruit And Nut Co Inc
Food 600943 PISTACHIOS KERNELS RAW 8/11 OZ SQ TUB, UPC 2052600943 601902 PISTACHIOS KERNELS RAW 10/14 OZ TAPE BAG, UPC 2052601902 601902.09 PISTACHIOS KERNELS RAW 10/14 OZ TAPE BAG BYERLYS, UPC 2052601902 600899 PISTACHIOS KERNELS RAW 30#, IUPAC 600901 PISTACHIOS KERNELS RAW 5#, UPC 2052600901 600900.05 PISTACHIOS KERNELS RAW 12/16 BAGLINE FESTIVAL, UPC 2052600900. 601902.08 PISTACHIOS KERNELS RAW 10/14 OZ TAPE BAG LUNDS RAW PISTACHIO KERNELS, UPC 2052601902. 5/31/204, 5/24/2014, 5/28/2014, 12/13/2013, 6/3/2014, 4/2/2014, 1/8/2014. Class I Bergin Fruit and Nut Company is initiating a recall on a number of pistachio products manufactured using pistachios supplied by ARO Pistachio Inc. Salmonella was found in the environment at the ARO Pistachio Inc. company. Bergin Fruit And Nut Co Inc
Food 600908.03 PISTACHIOS KERNELS R/S 12/16 OZ TRAY KOWALSKI, UPC 2052600908 600909 PISTACHIOS KERNELS R/S 16/7 OZ CLAMSHELL, UPC 2052600909 600909.03 PISTACHIOS KERNELS R/S 16/7 OZ CLAMSHELL KOWALSKI, IUPAC 600904 PISTACHIOS KERNELS R/S 30#, UPC 2052600904 600905 PISTACHIOS KERNELS R/S 5#, UPC 2052600905 600906 PISTACHIOS KERNELS R/S 12/16 OZ BAGLINE, IUPAC. 5/30/2014, 4/12/2014, 6/4/2014, 5/7/2014, 1/17/2014. Class I Bergin Fruit and Nut Company is initiating a recall on a number of pistachio products manufactured using pistachios supplied by ARO Pistachio Inc. Salmonella was found in the environment at the ARO Pistachio Inc. company. Bergin Fruit And Nut Co Inc
Food 603684 PISTACHIOS S/I/S 12/10 OZ GOLD BAG, UPC 2052603684 600913 PISTACHIOS S/I/S 12/12 OZ BAGLINE, UPC 2052600913 600913.11 PISTACHIOS S/I/S 12/12 OZ BAGLINE AMAZON, UPC 2052600913 600913.07 PISTACHIOS S/I/S 12/12 OZ BAGLINE DISPLAY BOX, UPC 2052600913 600923.05 PISTACHIOS S/I/S 12/12 OZ BAGLINE FESTIVAL, UPC 2052600923 600915 PISTACHIOS S/I/S 12/12 OZ TRAY, UPC 2052600915 603672 PISTACHIOS S/I/S 12/26 OZ TIN HOLIDAY CLOSED SLEEVE, UPC 2052603672 600921 PISTACHIOS S/I/S 12/8 OZ CLAMSHELL, UPC2052600921 603667 PISTACHIOS S/I/S 16/15 OZ TIN HOLIDAY CLOSED SLEEVE, UPC 2052603667 600912 PISTACHIOS S/I/S 25#, UPC 2052600912 600914 PISTACHIOS S/I/S 4/20 OZ TUB, UPC 2052600914 600914.03 PISTACHIOS S/I/S 4/20 OZ TUB KOWALSKI, UPC 2052600914 603677 PISTACHIOS S/I/S 4/36 OZ TIN HOLIDAY CLOSED SLEEVE, UPC 2052603677 603902 PISTACHIOS S/I/S 4/36 OZ TIN HOLIDAY OPEN SLEEVE, UPC2052603902 600911 PISTACHIOS S/I/S 5#, UPC 2052600911 600927.04 PISTACHIOS S/I/S 8/8 OZ SQ TUB BOULDER, UPC 2052600927 600927.05 PISTACHIOS S/I/S 8/8 OZ SQ TUB FESTIVAL, UPC 2052600927 601912 PISTACHIOS S/IS 10/14 OZ TAPE BAG, UPC2052601912 601912.09 PISTACHIOS S/IS 10/14 OZ TAPE BAG BYERLYS, UPC 2052601912 601912.08 PISTACHIOS S/IS 10/14 OZ TAPE BAG LUNDS, UPC 2052601912 603858.00 PISTACHIOS S/I/S 12/26 OZ OPEN SLEEVE IN SHELL PISTACHIOS, UPC 2052603858. 11/15/2013, 12/13/2013, 5/24/2013, 6/3/2014, 6/5/2014, 5/30/2014, 6/4/204, 5/31/2014,2/25/2014, 3/22/2014, 5/23/2014, 5/7/2014, 3/29/2014, 1/18/2014. 5/28/2014. Class I Bergin Fruit and Nut Company is initiating a recall on a number of pistachio products manufactured using pistachios supplied by ARO Pistachio Inc. Salmonella was found in the environment at the ARO Pistachio Inc. company. Bergin Fruit And Nut Co Inc
Food 600910 PISTACHIOS SPLITS RAW 30#, UPC 2052600910 4/25/2014 Class I Bergin Fruit and Nut Company is initiating a recall on a number of pistachio products manufactured using pistachios supplied by ARO Pistachio Inc. Salmonella was found in the environment at the ARO Pistachio Inc. company. Bergin Fruit And Nut Co Inc
Devices AlboGraft Knitted with Collagen, Bifurcate 14x08 Catalog Number: AMC1408 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. Lot number/Expiration Date 56890A 2015-04 Class I Blood blushing/leaking from the surface of the graft after implantation LeMaitre Vascular, Inc.
Devices AlboGraft Knitted with Collagen, Straight 15x06 Catalog Number: AMC1506 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. Lot number/Expiration Date 56890A 2015-04 Class I Blood blushing/leaking from the surface of the graft after implantation LeMaitre Vascular, Inc.
Devices Albo Graft Knitted with Collagen, Bifurcate 16x08 Catalog Number: AMC1608 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. Lot number/Expiration Date 56890A 2015-04 Class I Blood blushing/leaking from the surface of the graft after implantation LeMaitre Vascular, Inc.
Devices AlboGraft Knitted with Collagen, Bifurcate 18x09 Catalog Number: AMC1809 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. Lot number/Expiration Date 56890A 2015-04 Class I Blood blushing/leaking from the surface of the graft after implantation LeMaitre Vascular, Inc.
Devices AlboGraft Knitted with Collagen, Bifurcate 18x10 Catalog Number: AMC1810 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. Lot number/Expiration Date 56890A 2015-04 Class I Blood blushing/leaking from the surface of the graft after implantation LeMaitre Vascular, Inc.
Devices AlboGraft Knitted with Collagen, Bifurcate 20x10Catalog Number: AMC2010 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. Lot number/Expiration Date 56890A 2015-04 Class I Blood blushing/leaking from the surface of the graft after implantation LeMaitre Vascular, Inc.
Devices AlboGraft Knitted with Collagen, Straight 40x07 Catalog Number: AMC4007 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. Lot number/Expiration Date 56890A 2015-04 Class I Blood blushing/leaking from the surface of the graft after implantation LeMaitre Vascular, Inc.
Devices AlboGraft Knitted with Collagen, Straight 40x08 Catalog Number: AMC4008 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. Lot number/Expiration Date 56890A 2015-04 Class I Blood blushing/leaking from the surface of the graft after implantation LeMaitre Vascular, Inc.
Devices AlboGraft Knitted with Collagen, Straight 60x06 Catalog Number: AMC6006 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. Lot number/Expiration Date 56890A 2015-04 Class I Blood blushing/leaking from the surface of the graft after implantation LeMaitre Vascular, Inc.
Devices AlboGraft Knitted with Collagen, Straight 60x07 Catalog Number: AMC6007 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. Lot number/Expiration Date 56890A 2015-04 Class I Blood blushing/leaking from the surface of the graft after implantation LeMaitre Vascular, Inc.
Devices AlboGraft Knitted with Collagen, Straight 60x08 Catalog Number: AMC6008 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. Lot number/Expiration Date 56890A 2015-04 Class I Blood blushing/leaking from the surface of the graft after implantation LeMaitre Vascular, Inc.
Devices AlboGraft Woven with Collagen, Straight 15x26 Catalog Number: ATC1526 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. Lot number/Expiration Date 56890A 2015-04 Class I Blood blushing/leaking from the surface of the graft after implantation LeMaitre Vascular, Inc.
Devices AlboGraft Woven with Collagen, Straight 15x30 Catalog Number: ATC1530 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. Lot number/Expiration Date 56890A 2015-04 Class I Blood blushing/leaking from the surface of the graft after implantation LeMaitre Vascular, Inc.
Devices AlboGraft Woven with Collagen, Straight 30x16 Catalog Number: ATC3016 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. Lot number/Expiration Date 56890A 2015-04 Class I Blood blushing/leaking from the surface of the graft after implantation LeMaitre Vascular, Inc.
Devices AlboGraft Woven with Collagen, Straight 30x18 Catalog Number: ATC3018 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. Lot number/Expiration Date 56890A 2015-04 Class I Blood blushing/leaking from the surface of the graft after implantation LeMaitre Vascular, Inc.
Devices AlboGraft Woven with Collagen, Straight 30x24 Catalog Number: ATC3024 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. Lot number/Expiration Date 56890A 2015-04 Class I Blood blushing/leaking from the surface of the graft after implantation LeMaitre Vascular, Inc.
Devices AlboGraft Woven with Collagen, Straight 30x26 Catalog Number: ATC3026 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. Lot number/Expiration Date 56890A 2015-04 Class I Blood blushing/leaking from the surface of the graft after implantation LeMaitre Vascular, Inc.
Drugs AmBisome (amphotericin B) liposome for Injection, 50 mg, For Intravenous Infusion Only, Single-Use Vial, Rx Only, Marketed by: Astellas Pharma US, Inc., Northbrook, IL 60062, Manufactured by: Gilead Sciences, Inc., San Dimas, CA 91773, NDC 0469-3051-30. Lot #: 042262AD, 042262AD1, 042263AD, 042263AD1, 042264AD, 042265AD, 042265AD1, 042265AD2, Exp 06/2015; 42269AK, 042270AD, 042270AD1, 042270AD3, 042270AD4, 042273AD, Exp 07/2015 and 07/2016 (Germany only); 042285AD, Exp 08/2015 and 8/2016 (UK only); 042293AA, 042293AE, 042293AK, 042298AD, Exp 09/2015; 0422A6AD, Exp 10/15 (for Finland, Greece, Turkey) and Exp10/2016 (for Sweden, UK, Lebanon), 0422B0AD, Exp 10/2015 (for Turkey, Netherland, France), and Exp 10/2016 (for Poland), 0422B0AD1, Exp 10/2015, 0422C1AA, 042304AD, Exp 01/2016 (Spain), and Exp 01/2017 (for Germany, Switzerland), 042304AD1, 042311AD, Exp 01/2016, and Exp 01/2017 (France, UK). Class II Lack of Sterility Assurance; During a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in some media fill units. No contaminated batches have actually been identified in the finished product, but there is a possibility of contamination. Gilead Sciences, Inc.
Food Jacqueline's GOURMET COOKIES Almond Bursts COOKIES, Net Wt. 11 oz (8 units total) packed in clear plastic with white labeling----Shelf life is 12 months frozen and 7 days after baked. Store Item No: 3552153, UPC: 4173522011 Lot numbers: PB18353-12, PB19036-1, PB19036-2, PB19036-3, PB19036-4, PB19036-5, PB19036-6, PB17576-6, PB18257-10, PB18257-8, PB18777-1, PB18777-2, PB18777-3 Class II Undeclared Milk allergen Price Chopper Golub Corperisable Warehouse
Food Jacqueline's GOURMET COOKIES Brownie Burst Cookies, Net Wt. 11 oz (8 units in total) packed in clear plastic with white labeling--Shelf life is 12 months frozen and 7 days after baked. Store Item No: 3552273, UPC: 4173522010 Lot numbers: PB18906-10, PB18906-11, PB18906-12, PB18906-9, PB18906-3, PB18906-4, PB18906-5, PB18906-6, PB18905-10, PB18905-11, PB18905-12, PB18905-2, PB18905-3, PB20908-5, PB20908-6 Class II Undeclared Milk allergen Price Chopper Golub Corperisable Warehouse
Food Jacqueline's GOURMET COOKIES Raspberry Burst Cookies, Net Wt. 11 oz (8 units in total) packed in clear plastic with white labeling---Shelf life is 12 months frozen and 7 days after baked. Store Item Code: 3552393, UPC:4173522009 Lot Numbers: PB18363-4, PB18363-5, PB18363-6, PB18363-7, PB18363-8, PB18363-9, PB18363-15, PB18363-16, PB17833-3, PB18325-3, PB20781-3, PB20781-4, PB20781-5, PB20781-6 Class II Undeclared Milk allergen Price Chopper Golub Corperisable Warehouse
Devices The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient's electrocardiographic (ECG) rhythm and indicates whether or not it detects a shockable rhythm. The LIFEPAK 500 AED is intended for use by personnel who are authorized by a physician/medical director and is intended for use in the pre-hospital and workplace and community environments. PART NUMBERS: 3011790-001568, 3011790-001574, 3011790-001627, 3011790-001634, and 3011790-001650. SERIAL NUMBERS OUTSIDE the US: 41232265, 41232267, 41232269, 41232270, 41232271, 41232272, 41238207, 41238208, 41301145, 41301370, 41301371, 41301372, 41301373, and 41301374. SERIAL NUMBERS IN THE US: 41134905, 41134906, 41134907, 41135982, 41135983, 41135984, 41135991, 41135992, 41135993, 41135994, 41135995, 41135996, 41135997, 41135998, 41135999, 41136000, 41136001, 41136002, 41136003, 41136004, 41136005, 41136006, 41136007, 41136008, 41136009, 41136010, 41136011, 41136012, 41136013, 41136014, 41136015, 41136016, 41136017, 41136018, 41136019, 41136020, 41136021, 41136022, 41136023, 41136024, 41136025, 41136026, 41136027, 41136028, 41136029, 41136030, 41136031, 41136033, 41136034, 41136035, 41136036, 41136037, 41136038, 41136039, 41136040, 41136060, 41136061, 41136062, 41136063, 41136064, 41136065, 41136066, 41136067, 41136068, 41136069, 41136070, 41136071, 41136072, 41136073, 41136074, 41136075, 41136076, 41136077, 41136078, 41136079, 41136092, 41136093, 41136094, 41142873, 41145359, 41145360, 41145361, 41145362, 41145363, 41145364, 41145365, 41145366, 41145367, 41145368, 41145369, 41145370, 41145371, 41145372, 41145373, 41145374, 41145375, 41145376, 41145377, 41145378, 41164115, 41232002, 41232003, 41232004, 41232005, 41232249, 41232250, 41232251, 41232252, 41232253, 41232254, 41232255, 41232256, 41232257, 41232258, 41232259, 41232260, 41232554, 41239182, 41239183, 41239184, 41239185, 41239186, 41239187, 41239188, and 41239189. Class II The LIFEPAK 500 Automated External Defibrillator (AED) could be susceptible to malfunction due to an assembly error. If affected, the malfunction would be the result of internal shorting on a printed circuit board assembly and could render the device inoperable. Physio Control, Inc.
Devices STERIS Fine Traction Device, one unit per box Product Usage: The Fine Traction Device is used to provide traction and enable fine adjustments to traction and orientation of the leg during orthopedic procedures. The following serial/lot numbers are affected by this recall: 0404913150, 0404913151, 0404913152, 0404913153, 0408713001, 0408713002, 0408713003, 0408713004, 0408713005, 0408713006, 0409813097, 0409813098, 0409813099, 0409813100, 0410113001, 0410113002, 0410713024, 0410713025, 0410713026, 0410713027, 0410713028, and 0410713029. Class II A bearing used in the assembly of the Fine Traction Device did not perform successfully in pre-release reliability testing; a replacement bushing passed reliability testing and was substituted per a change order. The change order authorized use of the substitute bushing in assembly of the Fine Traction Accessory; however, inadvertently the new part was not implemented. During complaint evaluation of a Fine Traction Device returned by a Customer it was determined that the original part, the bearing, was used in Fine Traction Devices distributed to Customers. Steris Corporation
Devices GE Healthcare Infinia Hawkeye 4 Option For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera (this includes GE Quasar Nuclear Medicine Systems). Nuclear Medicine Systems Infinia devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. 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662608NU01, 662772INFRM1, 662772INFRM2, 662772INFRM4, 671USNHINF, 678474INF, 681342INF1, 681342INF2, 681342INF3, 681342INF4, 70027NUC03, 70060NUC12, 701234INF, 701234INF2, 701364INF, 701774NM, 701857NM, 701952NM, 702255INF, 702360CHNM, 702369NM, 702388VNM, 702853NM, 703391INF1, 703391INF2, 703504HAWK1, 703558INF, 703689INF4, 703698INF1, 703858HAWK, 703858INF, 704225INF1, 704225INF2, 704304INF1, 704304INF2, 704316INFI, 704355INF1, 704355INF2, 704384HAWK1, 704384INFI2, 704384INFI4, 704384INFI5, 704384INH1, 704446INF1, 704487INFINIA1, 704660HAWK, 704667INF1, 704739INFI, 704783INFI1, 704783INFI2, 704783INFI3, 704863INF1, 705674HAWKEYE, 705674INFINIA, 705759HAWKEYE, 705759INFINIA2, 706278INF, 706291HINM, 706494HNM, 706651INF, 706651NUC, 706733INF, 707822INFINIA, 707963IN, 708660INF, 708684INF1, 708747INFACQ, 709637INFINIA1, 709651INFINIA, 709651INHE4A, 709737INFINIA, 709737INFINIA2, 709737INFINIA3, 712279INF, 713242INF1, 713242INF2, 713242INF3, 713359INF1, 713456INF, 713722INF, 713785SLINF1, 713785SLINF2, 713785SLINF3, 713794INF, 713794INF2, 713794INF3, 713ACCINF1, 714456INFINIA, 714953INFINIA, 715423INF, 715623INF, 715839INF, 716366INF, 717544INFINIA, 717627INFINIA, 717633INF1, 717633INF2, 717782INF, 718150INF1, 718240INF1, 718240INF2, 718250INF1, 718334INF1, 718334INF2, 718405INF1, 718518INF1, 718584INFINIA, 718616INF, 718630INF1, 718883INF1, 718883INF2, 718948INF, 718963INF1WH, 719333IH, 722050NU01, 724226INF1, 724357INF1, 724450INFINIA, 727461VG, 727521INF, 727581INF, 727843INF1, 727863INF1, 727893INF, 727942INF, 731425INFH1, 731425NMIC1, 731425NMRM, 731644INF, 732292INFINIA, 732321IH4, 732321INFINIA, 732530INFINIA, 732530INFINIA2, 732776INFH4, 732840INFINIA, 732923INFINIA, 732937INFINIA, 734246INF, 734467INF, 734475INF, 734671INF, 740264INF3, 740264INF4, 740356INF1, 740356INF2, 740383INF1, 740623INFINIA, 740922INFINIA, 740944NU01, 757259INF1, 757312INF1, 757312INF2, 757388INF2, 757395INF1, 757398INF1, 757398INF2, 757668INF1, 757722INF1, 757886INF1, 757889INF1, 760241INF1, 760452INF1, 760778INF1, 760873NUC, 763MRCYINFI, 763UNTYINFI, 765456INF, 765552INF, 770219INF, 770229INF, 770382INM, 770400INF, 770535INF1, 770751INF, 77137NUC01, 77139NUC05, 77187NUC01, 77260NUC03, 772LMCNM2, 773665INF1, 773665INF2, 77383NUC03, 773884INF, 773947INF, 773995INF, 774442INF, 775423INF1, 77624NUC01, 77624NUC03, 780489INFINIAH4, 780489INHE4B, 780489INHE4C, 780715INHE4A, 780875INFINIA, 781340INF, 781340INF2, 781340INF3, 781477INF, 781979INF1, 783348NU01, 785462CI, 786308INF1, 786308INF2, 787653INFINIA2, 787758INFINIA2, 787764INFINIA-1, 787848INFINIA, 78NMIH2564713, 801268INF1, 801299INF1, 801314INF1, 801357INF1, 801357INF2, 801387INF1, 801408INF, 801408INF2, 801465INF1, 801479INF, 801479INF2, 801501INF1, 801584INF1, 801584INF2, 801584INF3, 801588INF, 801ALTAINF2, 801IMCCARD, 801IMCINF, 801IMCINF1, 801RHINF, 801SLCINF, 802257INF, 802388INF, 802775INFINIA, 803329HAWK, 803329INFIN1, 804225INF1, 804254INF, 804281INF1, 804323INF1, 804594INF1, 804675INF1, 804957INF1, 804957INF2, 805370INF1, 805489INF1, 805543INF1, 805737INF1, 806354ACINFINIA, 806354NWINF, 806354NWINF2, 806GRACENM, 809758INFINIA, 812265KDINF, 812426INF, 812485INF, 812522INF, 812842INF1, 813788INF1, 813870INF, 813USFINF1, 814333INFINIA1, 814333INFINIA2, 814362INFINIA, 814452INF1, 814467INF, 814533INF, 814534INF1, 814643INF, 814723INF, 814877INFINIA, 814889INFINIA, 815395INF, 815432INF, 815432INFINIA, 815741INF1, 815741INF2, 815756INF, 816271SJINF, 816348INF1, 816380CASSINF, 816392RINF, 816404INF1, 816836CIIN, 817255INF, 817346INF, 817472INF, 817599INF, 817685INF, 817920INF, 818409INF2, 818884INF1, 818907INF1, 819357BINFINIA, 819378INFINIA, 819537INFINIA, 819537INFINIA2, 819563CINFINIA, 819595INFINIA, 828262INFINIA, 828286INFINIA, 828298HAWK1, 828298HAWK2, 828315HWK4, 828586INFINIA, 828696INFINIA1, 828766INFINIA, 828883INFINIA, 831755IN1, 832505NM1, 832522INF, 832522INF2, 832824INF, 843402INF, 843402INF2, 843412INF, 843431IN, 843606INF1, 843674IN1, 843674IN2, 843674IN3, 843689INF, 843692IN1, 843724INF, 843724INF2, 843777IN1, 843777IN2, 843777IN3, 843782INF, 843797INF1, 843832INF, 845794INFINIA, 845987INFINIA, 847480INF, 847535INFACQ, 847990INF1, 849010NU01, 850494HAWK, 850883ENM, 856247INF, 856363INFINIA, 858554EDCINF, 858554INF1, 858554INF2, 859268INF1, 859313INF, 859498INF1, 860344INF, 860350INIF, 863679INF1, 863680INF1, 863687INF1, 863687INF2, 864560HAWK1, 864675HAWK, 864675INFI, 864SPAHK1, 864SPAHK2, 865271NM1, 865373INF, 865429INFINIA, 865545INFINIA1, 865717INF, 865947INFINIA1, 865977INF, 876259NU01, 885INFI1, 885INFI2, 900010NU06, 901287INF1, 901495INFHAWK, 901495INFINIA, 901516NINFHK, 901516UINFHK, 901523INF1, 901523INF2, 901765INFRM8, 902567NUCINH4, 903416INF, 903731INFINIA, 903785INF, 903UTINF, 904202INF1, 904276INF1, 904321INF1, 904542NM, 904627INF1, 904627INF2, 904819INF1, 904821INF3, 904821NM1, 904821NM2, 905358INFINIA, 905372INFINIA, 905472INFINIA, 905472INHE4A, 905521INFHE4, 905522INFINIA, 905522INFINIA2, 905577INFHE4A, 905577INFHE4B, 905683IN1, 905731INFINIA, 905773INFINIA1, 905813INFINIA, 905813INFINIA2, 905832INFINIA, 905845INFINIA1, 905848INFINIA, 905855INFINIA, 905855INFINIA2, 905855INFINIA3, 905883HAWKEYE, 905895INFINIA1, 905895INFINIA2, 906293INF, 906774INF, 906776INF, 907562NM1, 907562NM2, 908522INFINIA, 908522INFINIA2, 908522INFINIA3, 909825INFINIA, 910323INF1, 912486EGNC, 912691SCNC, 913345INF1, 913541INF1, 913588INF, 913588INF1, 913588INF2, 913676SMIM, 915521HNM1, 915577NM1, 915595GNM1, 916453IN, 916537IN, 916537IN2, 916703IN1, 916703IN2, 916733IN, 916781IN, 916782IN1, 916782IN2, 916983INFN1, 918294INF1, 918307INF1, 918307INF2, 918376INF1, 918494INF1, 918494INF2, 918494INF3, 918502INF1, 918599INF1, 919684INF1, 919684INF2, 919684INF3, 919784INF1, 919934INF, 920288INF, 920288INF2, 920451INF, 920456INF, 920568INF, 920684INF, 920729INF, 920738INF, 920738INF1, 920738INF2, 920794INF, 920849INF, 920907INF, 925370IN, 925779IN, 925785IN, 925INF, 928214INF, 928442INF, 928537INF, 928855INF, 931381NM2, 931403NM1, 931967NM, 937208INF1, 937208INF2, 937268INF1, 937278INF, 937328INF1, 937328INF2, 937374INF1, 937386INF, 937390INF1, 937393INF, 937438INF, 937440INF1, 937440INF2, 937832INF1, 941235INF, 941629INF, 941637INF, 941766INF2, 941VRMCINF, 951672INF1, 951696INF1, 954265INF1, 954735INF1, 954735INF2, 954978INF1, 956350NM1, 956687INF2, 956971NM1, 970350IH, 970945INF, 972394INF, 972498INF, 972540INF, 972596INF, 972969INF, 973579INFINIA, 973625INFINIA, 973676INFINIA, 973831INFINIA, 973877INFINIA, 973971INFINIA, 978521INF, 979241INF, 979532INF1, 980212INF1, 985230INF, 985646INF, 985649INF1, 985649INF2, 985785INF, 989723INF1, 989723INF2, A004NU11, A186363001, A4169304, A4194407, A51043155, A51043187, A5107756, A5107766, A5109126, A5109665, A5109666, A5111127, A5111240, A5112411, A5113627, A5114292, A51149103, A5115111, A51152163, A51152164, A5118056, A5118088, A5120724, A5123523, A5124139, A5127292, A5128755, A5128757, A5129026, A5129959, A5152964, A5153612, A5162248, A5172907, A5172908, A5178021, A5181660, A5181662, A5189714, A5197927, A5197934, A5198016, A5215935, A5216823, A5216824, A5224207, A5267107, A5279301, A5279302, A5306502, A5315551, A5352208, A5367805, A5547414, A5634003, A5649008, A5719812, A58080111, A58080134, A5924402, A99263311, AC001NU14, AC001NU18, AF1026NM01, AH1908NU01, AH1908NU02, AH3403NU01, AH3701NM05, AH4307NM05, AH4660NM06, AH5117NU02, AH5249NM04, AH5293NM04, AH5689NU01, AH5689NU03, AH5689NU04, AH5844NM05, ALM0131, AMS0338, APL0232, ARHINFI, B1650218, B1768001, B4155415, B4182004, B5119121, B5142302, B5142304, B5174320, B5315345, B5357630, B5365422, B5395703, B5483443, B5618331, BCHINF1, BRMCINF, C001NU06, C001NU10, C4191749, C4191765, C5120912, C5120915, CC3899NU01, CE561221, CFRHINF, CHAM01NU01, COR359309, COR369576, COR373273, COR373282, CRAVENINF1, CRAVENINF2, CRAVENINF3, CS1008NM03, CS1021NM03, CS1052NM08, CS1052NM09, CS1277NM01, CS1277NM02, CS1318NM01, CSNMINFINIA, CY1015NM01, D5111602, D5111607, DE492A51, DE528467, DE539254, DE6588112, DEH13556, DEN01721, DEN01723, DEN01725, DEN01727, DHG0539, DK1022NM05, DK1023NM03, DK1023NM05, DK1026NM07, DK1026NM08, DK1029NM05, DK1065NM04, DK1065NM05, DPN00002, DVT0138, DZ1035NM03, DZ1035NM04, DZ1147NM01, DZ1279NM01, DZ1338NM01, E001NU16, E4858901, EE1019NM02, EE238526, EEF51540, EG1100MN01, EG1124MN02, EG1538MN01, EG1826MN01, EMM0131, F5119151, FE443890, FEB33835, FEE12426, FEG46134, FHEINF, FI1000MN04, FI1003MN05, FI1003MN06, FI1010NM01, FI1019MN01, FI1021MN01, FI1023MN02, FI1029MN01, FI1064MN01, FI1153MN01, FPG86405, G4191710, GE1004NM01, GILESINF, GOLD001642, GOLD010343, GOU0137, GOU0138, GPQ19105, H002NU01, H010NU04, H010NU08, H2094NUC07, H2094NUC28, H2100NUC02, H2193NUC13, H4858974, HC0074NU01, HC0507NU03, HC0842NU01, HC0863NU01, HC0892NU04, HC1249NU01, HC1249NU02, HC1819NU01, HC2252NU01, HC2720NU02, HC3442NU01, HC4387NU02, HC4480NU01, HC7475NU03, HDB0130, HGL0233, HGV0130, HLUE01NU01, HLV0334, HR4103NM01, HU1039NM02, HU1099NM01, IE1006MN04, IE1029MN04, IE1029MN05, IE1053MN01, IE1085MN05, IE1100MN01, IE1110MN01, IE1510MN09, IE1510MN12, IE1510MN16, IE1564NM01, IE1564NM03, IL1018NM07, IL1018NM08, IL1020NM25, IL1020NM31, IL1028NM26, IL1041NM18, IL1041NM22, IL1041NM28, IL1041NM29, IL1042NM09, IL1043NM20, IL1059NM07, IL1062NM26, IL1068NM05, IL1069NM06, IL1069NM11, IL1331NM01, INF2649553, IR1049NM01, IR1501NM01, JO1034NM01, JOHNINF, KW1001MN23, KW1001MN25, KW1005MN11, KW1005MN14, KW1006NM01, KW1013NM01, KW1013NM02, KW1018MN05, KW1018MN06, KW1018MN08, LB1122NM02, LDD0431, LDD0433, LGMCINF, LGMCINF2, LT4000MN01, LT4000MN02, LV4002NM02, M1106608, M1279727, M1400803, M1804913, M1804914, M204493801, M2147255, M218669001, M2269829, M23084315, M256517203, M2645705, M2846905, M4018099, M4018536, M4023087, M4024095, M40345193, M4040544, M4111216, M4135141, M4135145, M4143953, M4144332, M4144340, M4145143, M4159227, M4159228, M4159235, M4159460, M4160449, M4163763, M4167153, M4184856, M4191430, M4194031, M4198189, M4215553, M4234232, M4234235, M4479619, M4480229, M4480232, M44827146, M4496943, M5172527, M54606103, M7411101, M7411106, M8572211, M9162716, M9164758, M9319116, M9886832, MA1020NM01, MA1272NM01, MA1439NM01, ME051533, ME208350, ME244391, ME244393, MEX68919, MPP0131, MPX46902, MPX47106, MPX52309, MPX82204, MPX99201, MQ1000MN04, MT1014NM01, MT1014NM02, MVINFNM2, N001NU02, N001NU06, NA1027NM01, NASHNM2, NE209938, NM156449, NM18342, NM18346, NM18356, NM18357, NM18363, NM18365, NM18409, NM18444, NM18451, NM18471, NMCR-17849, NMCR-17980, NMINDTCRL0206, NMINDTCRL0227, NMINDTCRL0311, NMINDTCRL0351, NO1000MN03, NO1000MN06, NO1016MN16, NO1054MN01, NO1068MN07, NO1068MN09, NO1070MN07, NO1088MN09, NO1116MN09, NP739716, NPV15964, NUC5178133HM6, O005NU14, OBNM1, ORMCINFINIA1, ORMCINFINIA2, P4211482, PC1268NU03, PC1818NU03, PC3906NU02, PC3964NU02, PC3970NU02, PC5995NU01, PC8118NU01, PER03520, PER08009, PITTINF4, PITTINF5, PK1001NM01, PK1031NM01, PK1032NM01, PK1180NM03, PK1180NM08, PK1184NM01, PK1278NM01, PK1307NM01, PK1335NM01, PK1336NM01, PK1355NM01, PL1003NM03, PL1143NM03, PL1143NM06, PL1692NM01, PM1633NU03, PMR12506, PPR08202, PPR12213, PPR59030, PPR97306, PPS06907, PRINCEINF, R4211480, RO1224NM01, RU1018NM01, RU1021NM02, RU1085NM02, RU1091NM01, RU1095NM02, RU1152NM02, RU1212NM01, RU1284NM01, RU1294NM01, RU1302NM01, RU2050NM01, RU2199NM01, RU2311NM01, RU2311NM02, RU2526NM01, RU2527NM02, RU2527NM03, RU3143NM02, RU3314NM01, RU3424NM01, RU3448NM01, RU3508NM01, S4160059, S4160079, SA1001MN01, SA2146NM01, SLGHINF, TN1366NM01, UC4109NU02, UC7655NU03, UC7655NU04, UE282633, UE282648, UE720407, UEW19003, UEW19005, UK1110NM01, UK5002NM01, UP285A41, UPW00402, V1471114, V2147210, V2728105, V2728109, V2943412, V2943415, V4198004, V6414104, V7405209, V7406615, V7406617, V8572204, VASINF, VCWESTINF, VVMCINF1, X100611101, X105967809, X105967813, X119197203, X151957601, X2034002, X4211026, X59007307, X61014001, Y004NU08, Y004NU11, YE364413, YE364417, YE626937, YN1196, YN1200, YN1539, YN1540, YN1541, YN1542, YN1543, YN1544, YN1545, YN1546, YN1547, YN1548, YN1549, YN1550, YN1551, YN1552, YN1553, YN1554, YN1555, YN1556, YN1557, YN1558, YN1559, YN1560, YN1561, YN1562, YN1563, YN1564, YN1565, YN1566, YN1567, YN1568, YN1569, YN1570, YN1571, YN1572, YN1573, YN1574, YN1575, YN1577, YN1578, YN1579, YN1580, YN1581, YN1582, YN1583, YN1584, YN1585, YN1586, YN1587, YN1588, YN1589, YN1590, YN1591, YN1592, YN1593, YN1594, YN1595, YN1596, YN1597, YN1598, YN1599, YN1600, YN1601, YN1641, YN1650, YN1730, YN1742, YN1743, YN1744, YN1745, YN1760, YN1802, YN4218, YN4219, YN4220, YN4221, YN4222, YN4223, YN4224, YN4225, YN4226, YN4227, YN4228, YN4229, YN4230, YN4231, YN4232, YN4233, YN4234, YN4235, YN4236, YN4237, YN4238, YN4239, YN4240, YN4241, YN4242, YN4243, YN4244, YN4245, YN4248, YN4249, YN4250, YN4251, YN4252, YN4253, YN4254, YN4255, YN4256, YN4257, YN4258, YN4259, YN4260, YN4261, YN4262, YN4263, YN4264, YN4265, YN4266, YN4267, YN4270, YN4280, YN4288, YN4300, YN4312, YN4818, YN4819, YN4820, YN4821, YN4822, YN4824, YN4825, YN4830, YN4833, YN4900, YN4918, YN4919, YN4920, YN4921, YN4922, YN4923, YN4924, YN4925, YN4926, YN4927, YN4928, YN4929, YN4930, YN4931, YN4932, YN4933, YN4934, YN4935, YN4936, YN4937, YN4938, YN4939, YN4941, YN4942, YN4943, YN4944, YN4945, YN4946, YN4947, YN4948, YN4949, YN4950, YN4951, YN4952, YN4953, YN4954, YN4955, YN4990, YN4992, YN4999, YN5000, YN8001, YN8002, YN8003, Z001NU06, ZA1806NM12, ZA1807NM11, ZA1808NM13, ZA1820NM04, ZA1835NM24, ZA1835NM25, ZA2006NM04, ZA2008NM04, ZA2212NM02, ZA2246NM01, ZA2261NM01, ZTP0133, ZWL0437. Class I GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. GE Healthcare, LLC
Devices GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition typed and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT, Gated SPECT, Whole body SPECT, Camera based PET). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation correction and functional anatomic mapping. System ID: 2998, 6970, 12865, 21414, 38070, 53263, 55461, 56948, 58230, 58378, 58379, 58483, 58510, 58582, 58622, 58630, 58711, 58785, 58797, 58808, 58810, 58871, 58883, 58919, 58958, 58993, 59012, 61061, 63422, 66515, 75074, 79722, 79966, 84636, 92635, 99691, 0850260033, 0850260034, 0850260035, 0850260038, 0850260040, 0850260041, 0850260042, 0850260046, 0850260048, 0850260054, 0850260057, 0850260062, 0853940029, 0853940068, 0853940069, 0853940077, 0853940078, 0853940080, 0853940082, 0856260014, 0856260019, 0910265011, 0910453006, 082426010009, 082426010010, 082426010011, 082426020002, 082426030009, 082426030010, 082426030015, 082426030016, 082426030018, 082426040016, 082426040020, 082426040021, 082426040024, 082426040025, 082426040026, 082426040029, 082426050001, 082426050002, 082426050003, 082426070014, 082426070015, 082426070016, 082426080006, 082426080007, 082426080009, 082426090013, 082426100017, 082426100019, 082426100020, 082426100023, 082426110002, 082426120003, 082426120004, 082426130012, 082426130013, 082426130014, 082426130015, 082426130016, 082426130019, 082426140005, 082426140007, 082426140008, 082426140009, 082426140011, 082426140012, 082426150003, 082426150006, 082426160012, 082426160014, 082426160016, 082426160017, 082426160019, 082426160020, 082426160022, 082426160023, 082426180003, 082426190008, 082426190010, 082426200002, 082426210002, 082426210003, 082426210010, 082426220006, 082426230008, 082426230010, 082426250002, 082426280001, 082426290004, 082426310005, 082426310007, 082426310008, 08302603017002, 08302603135243, 08302606123002, 08302621006334, 083026031062021, 083026242100654, 083026590040004, 083026590040010, 083026598000594, 083026826753913, 0382E00013, 00023NUC06, 0009D, 00132NUC02, 00216NUC09, 00243NUC11, 00243NUC15, 00243NUC17, 00269NUC07, 00323NUC02, 00357NUC02, 00555NUC01, 00584NUC01, 00584NUC04, 0112B, 0277A, 030010NU02, 030028NU01, 030036NU06, 030082NU10, 030151NU05, 030220NU02, 030355NU02, 030388NU01, 0306A, 0343A, 0360A, 06007NUC16, 080041NU01, 082426040029P, 082426050001P, 082426140005P, 0850EL0011, 0850EL0012, 10433NUC01, 110012NU02, 110965NU05, 130083NU07, 13228MILLEN, 16003NUC03, 160070NU01, 190226NU17, 190282NU04, 203694MIL, 203852VG, 203932VG, 204837VG, 205823NMVG, 205933VH, 206288VG, 206598VG, 207795VH, 208529VG, 209334LNVG1, 209526MILVG, 212562VG, 215893VG, 220166NU01, 223410MILVG, 225763MVG, 228818MILLVG, 248828H, 248828VG, 248937VG, 256235OPNM1, 262785VG, 2894872VG2, 2894872VG3, 301896VG, 304256VG, 304487VG, 309662SJVG, 310231VGH1, 310289VG1, 312864VG, 313299VG, 334794MILVG, 361575VG, 402449SJVG, 404605PVGH, 404712VG, 406782SNM, 407277FVG2, 407896FVG1, 407933KVG, 408947VG, 409291HVG, 410605NM1, 410955VG1, 410955VH, 412359VG, 413781VG1, 413781VG2, 414219VG, 414328VG, 414384VG, 414447VG, 414544HEYE, 414544VG, 414777MIL, 414777VG2, 414961VG, 416284VG, 416284VG2, 416290VG, 416444VG, 416469DVH, 416534VG1, 416534VG2, 416586VG, 416656VG, 416747VARICAM, 416747VG, 416756VG, 418404NU01, 418862VARICAM, 419383VG, 440329VG, 443643VG, 450359VG1, 450359VG2, 480981NM1, 501686VG, 508997VG, 509575PYVGH, 510486VG1, 512753VG, 514495VG, 515263LVG, 516256VG, 518271SVG, 519421VG, 520757NM1, 530529VG, 540186NU01, 540596N3, 540953VG, 541276AVG, 559688NM1, 570791HAWK, 580355VGACQ, 589907MVG, 600062NM01, 601426VG, 602406VG, 602870NM1, 605333HAWKEYE, 608263VG, 608364VG, 609267VG, 610954VG, 613548VG, 613548VG2, 615322NM2, 615791VG, 630801VG, 70050NUC06, 705324VG, 705327VARICAM, 705743VG, 706845VG, 707554VG, 708422MIL, 708783VG, 714774VG, 715361VG, 716694VG, 716859VG, 717657VG, 718759VG, 718780GENIEVG, 718780VG, 73240-1, 781278VG, 781744VG2, 781744VH, 786090NU03, 787782VARICAM-1, 804281VG1, 807343BMILLVG, 807343CMILLVG, 809758VARICAM, 812537VG, 813725VG, 813788VG, 815842SJVG, 819563CVG, 819822VG, 828212VG, 828213VG, 843792NUCH, 845437VG, 847695MILMVG, 847842VG, 860343VGOPC, 860344VG, 863494VG, 864573MBVG1, 904202VG, 905472VG, 905527HAWKEYE, 905683VG, 905684VG, 905684VG2, 905845VG, 905848VG, 905855VG, 905883VG, 905895VG, 912691SCVG, 914734VG, 919684VG1, 920459VG, 920729VG, 920887VG, 949760VG1, 956632MVG, 956687HKI, 970491VG1, 973754VG, 978466VG, 978741VG, 979764VGH1, 989269VG, A004NU10, A2846901, A5103321, A5107736, A5111021, A5114718, A5116033, A5128734, A5129932, A5132115, A5177338, A5177340, A5177344, A5177347, A5188524, A5215912, A5236208, A5306504, A5333009, A5353816, A5632411, AH0101NM02, AH0101NM03, AH3701NM04, AH4307NM04, AH4660NM05, ALK0130, ALK0131, APL0236, B4155407, B5119109, B5131812, B5315325, B5365411, B5483426, C5123638, CC0618NU13, CY1088MN04, D007NU07, DE282013, DE619831, DEL26415, DHG0536, DK1026NM05, DLF0237, E001NU09, EE1020MN01, EEF51528, FE416038, FE816127, FEB52048, FHALTVGH1, FHORLVGH1, G001NU07, GEC21815, GEE34020, H1404NUC06, H2103NUC06, H5174NUC02, HBER01NU02, HC2250NU01, HC2250NU02, HC2250NU03, HC3314NU01, HC4387NU01, HC5036NU01, HJJT01NU02, HOR0250, HR4106NM01, HT2106NU02, HT2106NU05, ID9320, IL1020NM01, IL1028NM03, IL1028NM13, IL1059NM01, IL1061NM01, IL1061NM05, IL1062NM01, IL1066NM03, IL1067NM03, IL1072NM01, JHOCVG10464, M001NU10, M001NU14, M2846904, M2881704, M4024091, M4134620, M4143939, M4144609, M4144845, M4145121, M4160707, M4164912, M4211044, M5400305, M5460632, MAYO1VG4, MAYO1VGH1, MAYO4VG3, MC6946NU02, ME260802, ME504345, ME612431, MPX24714, NM10374, NM73049, NM73050, NM81394, NO1012MN04, NO1015MN03, NO1016MN27, PC0173NU06, PC0396NU03, PC2306NU01, PC4178NU01, PER02544, PER10924, PER10925, PL1003NM01, PL1008NM01, PL1143NM01, PMR12503, PPR12206, RADNETNM1724, RU1100NM01, RU1457NM01, RU1591NM01, SK1071NM01, SK1082NM01, U001NU12, UC1129NU01, UC1769NU07, UC4092NU01, UC4109NU01, WH231NM1, YE645816, YE645817, YN0438, YN0440, YN0444, YN0448, YN0450, YN0454, YN0455, YN0468, YN0475, YN0477, YN0479, YN0482, YN0486, YN0493, YN0498, YN0502, YN0506, YN0542, YN0543, YN0544, YN0638, YN0639, YN0640, YN0641, YN0642, YN0643, YN0844, YN0845, YN0846, YN0847, YN0848, YN0849, YN0850, YN0851, YN0852, YN0853, YN0854, YN0907, YN0909, YN0910, YN0911, YN0912, YN0913, YN0914, YN0915, YN0917, YN0918, YN0919, YN0920, YN0921, YN0922, YN0923, YN0924, YN0966, YN0979, YN0980, YN0981, YN0982, YN0983, YN0984, YN0985, YN0986, YN0987, YN0988, YN1000, YN1009, ZA1807NM08, ZWL0431, Class I GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. GE Healthcare, LLC
Devices Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition typed and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT, Gated SPECT, Whole body SPECT, Camera based PET). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation correction and functional anatomic mapping. System ID: 57503, 57584, 57588, 57711, 57727, 57734, 57815, 57873, 58826, 0828960002, 082426010006, 082426130005, 082426160008, 00243NUC09, 0090J, 0177A, 0201B, 0252A, 0272B, 0274B, 0279A, 0280A, 0286A, 030038NU04, 030151NU02, 030232NU04, 080019NU03, 210001NU01, 250565NUC2, 416586HELIX, 418589HELIX, 506739HELIX, 519464HELIX, 61420HELIX, A5110123, A5153605, AP2302NM01, B4213128, B5315316, CS1013NM01, FE8161EL18, IL1041NM01, IL1042NM02, IL1062NM02, M4148612, M4392002, MPX247EL09, NE4191EL15, PL1139NM01, SK1042NM01. Class I GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. GE Healthcare, LLC
Devices Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system. Product Usage: The Brivo NM 615 is an emission computed tomography system intended to detect the location and distribution of gamma ray photon emitting radionuclides in the body and to produce cross-sectional images through computer reconstruction of the data. The Brivo NM 615 system is intended for General Nuclear Medicine imaging procedures using variety of scanning modes supported by various acquisition types. This generic type of device may include signal analysis and display equipment, patient and equipment supports, and accessories. System ID: 030151NU17, 387171NU01, 405456NM615, 406222LN615, 478272NM, 702304NM615, A5635609, HC0541NU03, HC3366NU02, NM24011, NM24015, ZA1819NM04, ZA2446NM01. Class I GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. UPDATE: On July 03, 2013 GE notified hospitals that they are recalling several Nuclear Medicine Imaging Systems because serious injuries or deaths could occur due to the failure mode associated with this recall. GE advised hospitals that they cease use of their Nuclear Medicine systems until GE can complete an inspection of the system. In this second notification GE included all Nuclear Medicine Systems. GE Healthcare, LLC
Devices Discovery NM 630, dual detector free-geometry integrated nuclear imaging system. Product Usage: The GE Discovery NM 630 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM 630 system is a Nuclear Medicine (NM) system, which is intended to yield General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning modes include planar mode (Static, Multi-gated, Dynamic and Whole body scanning) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT). The acquisition types include single and multi-isotope/ multi peak frame/list mode single-photon imaging. The imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contouring. The GE Discovery NM 630 system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may be used for patients of all ages. System ID: 0850260134, 083026001113611, 00001NUC11, 00052NUC11, 030029NU05, 030151NU15, 030359NU07, 201418D630, 205333D630, 207664NM630, 208455NM630, 217544PH630, 251639D630, 262574D630, 269945D630, 270417D630, 281540D630, 301877D630, 305596D630A, 305596D630B, 317887D630, 318448D630, 318798D630, 319364D630A, 319364D630B, 330386D630, 334287NM630, 34363NUC01, 407431NU01, 409212NM630, 417533D630, 417781D630, 469814NM630, 580531NM630, 585922NM630, 601288D630, 601354D630, 601798D630, 609978D630, 614NCH630, 618443DISC1, 618842DISC1, 618942NM630, 619474D630, 651DSC630, 702388VNM2, 704355D630, 708684D630, 716372NM630, 719587D630, 770751D630, 773282D630, 801714D630, 804675D630A, 808485NM630, 813558D630, 813615D630, 814623D630, 815564D630, 816234D630, 843347D630, 843797TD630, 845454D630, 870939NU01, 870939NU02, 901226D630, 903GSD630, 904276DSC1, 904321DSC1, 905684D630, 913345D630, 918502DIS1, 936NMD630, 937SNHC630, 941LWRNM630, 956523D630, 978354DSV630, 989227D630, A5131865, A5366307, A5384208, A5812287, EG1040NM01, H002NU03, H3001NUC01, HC0863NU02, IE1018MN03, IE1044NM01, JHDSV630NM, M4216453, M4476428, M45052111, NM22073, NO1035MN06, NT3001, NT3002, NT3003, NT3010, NT3020, O009NU09, OSC630, PC3003NU01, PMAB01NU04, POIN630, PRINCE630, RTD0739, RU1136NM01, TP0004NU01. Class I GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. UPDATE: On July 03, 2013 GE notified hospitals that they are recalling several Nuclear Medicine Imaging Systems because serious injuries or deaths could occur due to the failure mode associated with this recall. GE advised hospitals that they cease use of their Nuclear Medicine systems until GE can complete an inspection of the system. In this second notification GE included all Nuclear Medicine Systems. GE Healthcare, LLC
Devices Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. System ID: 0828260021, 0828260022, 0850260118, 0850260122, 0850260128, 0850260131, 0850260132, 0853260094, 0853260099, 0856260033, 0856260034, 0856260035, 0910262297, 0910262304, 0910262310, 0910262319, 0910262322, 0910262325, 0910262344, 0910263223, 0910263228, 0910263231, 0910263235, 0910263239, 0910263241, 0910263243, 0910263250, 0910264135, 0910264141, 0910264147, 0910265074, 0910265075, 0910265076, 0920269097, 082426040043, 082426040044, 082426060005, 082426070028, 082426070030, 082426080020, 082426090029, 082426090030, 082426130029, 082426130030, 082426150026, 082426160042, 082426210020, 082426230020, 083026009408410, 083026023683711, 083026201006810, 00001NUC12, 00028NUC01, 00042NUC02, 00046NUC06, 00065NUC08, 00123NUC01, 00149NUC01, 00149NUC03, 00197NUC14, 00199NUC13, 00200NUC07, 00200NUC08, 00234NUC09, 00361NUC08, 00432NUC02, 010120NU19, 030037NU08, 030082NU13, 030133NU13, 030360NU01, 05462NUC05, 06007NUC19, 080041NU04, 100032NU05, 10497NUC20, 110017NU06, 110022NU05, 11018NUC08, 190052NU09, 190163NU04, 190163NU06, 204726D670NM, 210060NU02, 212639NMD670, 250370D670, 260010NU06, 262574D670, 305674D670, 309671SPECT, 403343D670, 403943D670, 403943D670B, 404686NMCT, 410955D670, 410D6701, 415353D670, 416495D670, 418549D670A, 418549D670B, 423495D670, 514281D670, 514338D670, 514842AD670, 514848D670, 514876D670, 519973D670, 529150NU05, 540332D670, 600092NM11, 610402D670NM1, 613548D670, 614NCH670, 615322NM5, 615893MMCT1, 617638DSV670, 630432D670, 720848D670, 803751D670, 819563D670, 819563D670B, 856247D670, 856247NM, 900010NU09, 905472D670, 905684D670A, 905684D670B, 905883D670, 972747NM670, 972935D670, A4169312, A4194844, A51051127, A51142126, A5125139, A5129983, A5196344, B4182011, B5140618, BG4009NM01, D007NU12, DK1029NU14, DK1047NM01, EE1020NM03, FE416061, FI1052MN01, GP1000NM01, HOR0281, IL1020NM36, IL1041NM30, IL1062NM29, M001NU42, M2002713, M251400603, M4134637, M4143630, M4143993, M4144126, M4145158, M4194042, M4198090, M4210246, M4215577, M4476424, M4505290, M5172553, M5400562, M5480777, M9409545, M9886847, MEX68915, NO1018MN06, NO1087MN09, NO1088MN16, NT1001, NT1002, NT1003, NT1004, NT1005, NT1006, NT1007, NT1008, NT1009, NT1010, NT1011, NT1013, NT1015, NT1020, NT2001, NT2002, O005NU27, PC8262NU01, PITT670, RTD0737, RU1095NM03, RU1279NM02, RU1949NM01, RU3451NM01, RU3467NM01, RU3623NM01, RU3637PT01, RU3713NM01, RU3900NM01, RU6340NM01, RU7175NM01, RU7187NM01, RU7505NM01, UX2305NU01, V4144610, V4169306, X102874005, X4144501, XM203402. Class I GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. UPDATE: On July 03, 2013 GE notified hospitals that they are recalling several Nuclear Medicine Imaging Systems because serious injuries or deaths could occur due to the failure mode associated with this recall. GE advised hospitals that they cease use of their Nuclear Medicine systems until GE can complete an inspection of the system. In this second notification GE included all Nuclear Medicine Systems. GE Healthcare, LLC
Devices Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine (NM) system using a variety of scanning modes supported by various acquisition types, and a CT component which is intended specifically for enabling attenuation correction and anatomical localization on SPECT studies System ID: 0910263253, 0910263256, 00139NUC08, 00162NUC11, 030232NU15, 215728OPT640, 262574O640, 270956NM640, 410543NUC640, 715735OPT1, 717782640NM, 808485NM640, 815564O640, 816234D640, 817250NM640, 847872O640, 901516GO640, 915839NU01, 928214NMCT, A5366308, A5639613, BD003NU01, DK1054NM03, RTD0782, XM203401. Class I GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. UPDATE: On July 03, 2013 GE notified hospitals that they are recalling several Nuclear Medicine Imaging Systems because serious injuries or deaths could occur due to the failure mode associated with this recall. GE advised hospitals that they cease use of their Nuclear Medicine systems until GE can complete an inspection of the system. In this second notification GE included all Nuclear Medicine Systems. GE Healthcare, LLC
Devices Medtronic Preimplantation Test Kit, Catalog No. 21047. The kit is indicated for use with Medtronic CSF-Flow Control Valves and Delta Valves, when a simple preimplantation test is desired to verify that the valve conforms to labeled product specifications. C22929 C40543 C56465 C80034 D16291 C25329 C42910 C57924 C80787 D16693 C25475 C43115 C62128 D00052 D20967 C25662 C43512 C65929 D01033 D22544 C28396 C45615 C66120 D07250 D25802 C29229 C46351 C68906 D07373 D30597 C33946 C46583 C69701 D07507 C36893 C49439 C71003 D10462 C36904 C49706 C73622 D11409 C38718 C51418 C76639 D13208 C39484 C52417 C78186 D14099 C40150 C53058 C79051 D16157 Class II Medtronic Neurosurgery is recalling the Medtronic Preimplantation Test Kit because the outer carton had expiration dates that were incorrect. The date on the outer carton is later than the expiration date for one or more of the individually packaged sterile components in the kit. Medtronic Neurosurgery
Devices Axiom Aristos MX Solid State Flat Panel Digital Imager, Model number 5895003. The device is used for diagnostic X-ray imaging. Model Number 5895003 with serial numbers 1052 through 2500. Class II Siemens issued a Field Safety Notice about the potential hazard to patients or operators when using the function "table top float" of the AXIOM Aristos MX. When repositioning a patient lying on the table top and releasing the table top, it is possible that the fingers of the patient or operator are between the table top and the detector tray and if the table top is moved, the fingers can be squeezed. Siemens Medical Solutions USA, Inc
Devices BD BBL Vancomycin Screen Agar, carton of 10 plates, catalog # 222204, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Vancomycin Screen Agar is used to test entercocci for resistance to vancomycin and to predict the synergistic activity of this antimicrobial with an aminoglycoside antimicrobial. Lot 3081136 Exp June 18, 2013 Lot 3073114 Exp June 12, 2013 Class II Microbiological identification media may exhibit reduced levels of Vancomycin. Becton Dickinson & Co.
Devices BD BBL Schaedler K-V Agar with 5% Sheep Blood, carton of 20 plates, catalog # 221555, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Vancomycin Screen Agar is used to test entercocci for resistance to vancomycin and to predict the synergistic activity of this antimicrobial with an aminoglycoside antimicrobial. Lot 3078263 Exp 5/16/13 Class II Microbiological identification media may exhibit reduced levels of Vancomycin. Becton Dickinson & Co.
Devices BD BBL CDC Anaerobe 5% Sheep Blood Agar with Kanamycin and Vancomycin (KV), packaged in cartons of 100 plates, Catalog # 221736, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** CDC Anaerobe 5% Sheep Blood Agar with Kanamycin and Vancomycin is used for the selective isolation of fastidious and slow-growing, obligately anaerobic gram-negative bacteria from a variety of clinical and nonclinical materials. Lot 3080083 Exp 6/4/13 Lot 3073075 Exp 5/29/13 Class II Microbiological identification media may exhibit reduced levels of Vancomycin. Becton Dickinson & Co.
Devices BD BBL Anaerobe CNA Agar with 5% Sheep Blood // Anaerobe Laked Sheep Blood KV Agar, packaged in cartons of 20 plates, Catalog # 297041, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Anaerobe Laked Sheep Blood KV Agar is used in a qualitative procedure for isolation of gram-negative anaerobic bacilli. Lot 3080366 Exp 5/31/13 Lot 3071134 Exp 5/28/13 Lot 3081061 Exp 6/4/13 Class II Microbiological identification media may exhibit reduced levels of Vancomycin. Becton Dickinson & Co.
Devices BD BBL BBE // CDC Anaerobe Laked Sheep Blood Agar with KV, packaged in cartons of 100 plates, Catalog # 297260, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Bacteroides Bile Esculin Agar (BBE) is recommended as a primary isolation medium for the selection and presumptive identification of the B. fragilis group. Lot 3071112 Exp 5/28/13 Class II Microbiological identification media may exhibit reduced levels of Vancomycin. Becton Dickinson & Co.
Devices BBL Brucella Laked Blood Agar with Kanamycin and Vancomycin (KV), Catalog # 297840, packaged in cartons of 20 plates, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Brucella Laked Blood with KV is used for the selective isolation of fastidious and slow growing, obligately anaerobic bacteria from the same specimen. Lot 3078280 Exp 6/27/13 Class II Microbiological identification media may exhibit reduced levels of Vancomycin. Becton Dickinson & Co.
Devices BD BBL BCYE Selective Agar with PAV, Catalog # 297880, packaged in cartons of 10 plates, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** BCYE Selective with PAV is used in qualitative procedures for isolation of Legionella species from clinical specimen and nonclinical (environmental) samples. It is similar to the Edelstein formula, except that the concentration of polymyxin B is reduced by half, and vancomycin is substituted for cefamandole. Lot 3078348 Exp 6/27/13 Class II Microbiological identification media may exhibit reduced levels of Vancomycin. Becton Dickinson & Co.
Devices BBL Campylobacter CSM Agar (Charcoal-Based Selective Medium), Catalog # 299614, packaged in cartons of 20 plates, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** BCYE Selective with PAV is used in qualitative procedures for isolation of Legionella species from clinical specimen and nonclinical (environmental) samples. It is similar to the Edelstein formula, except that the concentration of polymyxin B is reduced by half, and vancomycin is substituted for cefamandole. Lot 3078430 Exp 5/30/13 Class II Microbiological identification media may exhibit reduced levels of Vancomycin. Becton Dickinson & Co.
Drugs Oxygen, Compressed USP UN1072 Medical Gas supplied in a) 682 litres and b)165 litres cylinders, Rx only, Oklahoma Respiratory Care 800.262.9857, Norman, OK 73071 Lot numbers: 03141201, 03211201, 05021201, 06271201, and 11081201. Class II Failed impurities/degradation specifications: Purity readings for oxygen were out of specification. Oklahoma Respiratory Care Inc
Devices Radiohead Access Point 1.4 GHz Radiohead Access Point Firmware versions: C.00.04 & C.00.05 Part Number: 989803171211 Product Usage: IntelliVue Smart-hopping 1.4 GHz Access Point provides wireless connectivity between IntelliVue devices (listed below) and the Philips IntelliVue Information Center. MX40 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals. The MX4O is to be used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. Serial numbers ranging from: US12700465 to US20823366 Class II IntelliVue Smart-hopping 1.4 GHz Access Point may experience unexpected signal loss of several minutes impacting wireless connectivity Philips Healthcare Inc.
Drugs LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, Shade LIGHT 02, UPC 7 47930 00481 3, MAX HUBER RESEARCH LABS INC., DIST. NEW YORK, N.Y. 10022 -- MADE IN BELGIUM all lots currently in the market shipped before June 2013 Class III Subpotent Drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunscreen effectiveness may be less than labeled Max Huber Research Labs, Inc.
Drugs LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, Shade MEDIUM 03, UPC 7 47930 00482 0 --- MAX HUBER RESEARCH LABS INC., DIST. NEW YORK, N.Y. 10022 -- MADE IN BELGIUM all lots currently in the market shipped before June 2013 Class III Subpotent Drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunscreen effectiveness may be less than labeled Max Huber Research Labs, Inc.
Drugs LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, Shade DARK 04, UPC 7 47930 00483 7 --- MAX HUBER RESEARCH LABS INC., DIST. NEW YORK, N.Y. 10022 -- MADE IN BELGIUM all lots currently in the market shipped before June 2013 Class III Subpotent drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunscreen effectiveness may be less than labeled Max Huber Research Labs, Inc.
Devices Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. ARKN-000001, ARKN-000005, ARKN-000010, ARKN-000015, ARKN-000016, ARKN-000017, ARKN-000018, ARKN-000020, ARKN-000021. Class II Spacelabs ARKON Anesthesia System is recalled due to software defect. The System Status Computer may incorrectly determine that a communication error has occurred. If this situation occurs, a buzzer will activate and a yellow triangle will be displayed on the System Status Computer screen that alerts the user of this error. Del Mar Reynolds Medical, Ltd.
Devices TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies Per recall strategy. Class II Research Use Only (RUO) parameters were included in TEG 5000 User Manual. Haemonetics Corporation
Food White plastic bottle with blue cap containing 90 capsules; Ashwagandha Extract; 450 mg; CODE 4603; Manufactured by NOW FOODS; 395 S. Glen Ellyn Rd., Bloomingdale, IL 60108, USA UPC: 7 33739 04603 1; Product Code: 4603; Lot: 1599135; Best By: May 2015 Class II It has been determined that this product contains an undeclared ingredient, licorice extract, which contains glycyrrhizin derived from licorice root. NOW Foods
Devices ARTIS zee and zeego x-ray, angiographic system with Software Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed. Angiographic x-ray system Model numbers: 10094137, 10094139, 10094141, 10280959 Class II Siemens issued a customer safety advisory notice and field safety corrective action for a potential issue on Artis systems with Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed. The issue affects-DSA rotational acquisition. The restriction is related to any rotational 3D-acquisition program with real-time subtraction (e.g. 3D DSA). During the fill phase of the rotational aquisition, the subtraction is not correctly displayed on the live monitor in the control room. As subtracted images are not displayed correctly, this may lead the user to abort or redo the 3D protocol, potentially resulting in the application of an additional dose or contrast agent. 3D data are saved however, and available on the system. Siemens Medical Solutions USA, Inc
Devices Stryker brand Neuroform 3 Microdelivery Stent System, 4.5 mm X 20 mm, REF Catalog Number: E345020, Model/Product Number: M003450200, Product is manufactured by Boston Scientific Corporation, Fremont, CA and distributed by Stryker Neurovascular, Fremont, CA The Neuroform Microdelivery Stent System is intended for use with embolic coils for the treatment of wide neck, intracranial, saccular aneurysms arising from a parent vessel with a diameter of greater than equal to 2 mm and greater than equal to 4.5 mm that are not amenable to treatment with surgical clipping. Code: M003450200, Lot 15391019, Expiration Date: 2015-07 Class II The device is labeled incorrectly, in that, the device Model Number on the outer carton and inner pouch labels did not match, although both referenced the same lot number. The Model Number on the outer box states UPN M003E345020 (4.5mm x 20 mm Neuroform 3 Stent) while the pouch label states UPN M003E3450300 (4.5mm x 30 mm Neuroform 3 Stent). Stryker Neurovascular
Food Canned Mushroom Sliced 6 cans, 53oz Carton Code: CONF#4402 Can Code: PRO.03/30/2013 EXP.03/30/2013 3502/01080 805 1 PRO.03/39/2013 EXP.03/29/2016 3502/01080 388 Bar Code: 076215131037 Class III C. Pacific Foods is recalling canned mushroom sliced because it contains pesticide levels that are not approved for canned mushroom. C Pacific Food
Devices Rultract Retractor Ratchet Cover Plate Distributed by Pemco, Inc., Cleveland, OH 44131 Surgical retractor used to lift the incision site M/N 4100-IMR-6: S/N's: 4829-4839, 4845-4851, 4857-4871, 4874-4884, 4894-4908 & 4916-4923; M/N 4100-IMR-41: S/N's: 4840-4844, 4852-4856, 4888-4893, 4913-4915 & 4926-4927. Class II The firm became aware of the problem when a ratchet cover plate on a device was returned for repair showed signs of corrosion. Pemco Inc
Devices Sodium Bicarbonate, USP Provided bulk as raw material - label not applicable according to firm Dialysis Grade 1.5 Dialysis Grade 2 As an API or excipient in the manufacture of Medical Devices and Drugs Lots and sizes- 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015443 SBC DIALYSIS 2 GRADE 50 LB BAG Class II Church and Dwight Co., Inc. has initiated a recall for Sodium Bicarbonate, USP produced by the Old Fort, OH Sodium Bicarbonate Production facility due to metal and other contamination. Church & Dwight Inc
Food PRIESTER'S PECANS brand brand ROASTED SALTED PISTACHIOS, item #18010, Net Wt. 1 lb (454g), UPC 720056180104; item #15502, Net Wt. 8 oz (226.8g), UPC 001001155027; Stock No. 189, Net Wt. 2 lb (907g) The product is not coded. Class I Pistachios, which were supplied by ARO and subsequently recalled, have the potential to be contaminated with Salmonella. Priester Pecan Company, Inc.
Food PRIESTER'S PECANS brand NUTTY FAVORITES ASST, Stock No. 79, Net Wt 1 lb 10 oz (737g) The product is not coded. Class I Pistachios, which were supplied by ARO and subsequently recalled, have the potential to be contaminated with Salmonella. Priester Pecan Company, Inc.
Food PRIESTER'S PECANS brand FANCY ROASTED NUTS, Stock No. 7, Net Wt 12 oz (454g) The product is not coded. Class I Pistachios, which were supplied by ARO and subsequently recalled, have the potential to be contaminated with Salmonella. Priester Pecan Company, Inc.
Devices PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye. PASCAL Standard 2R/G System v2.x.x and PASCAL Streamline 2R/G Software v2.x.x Serial numbers: United States 33057910 33060410 33063610 66078611 66084911 66085111 66085511 Out of United States OMC-179 11138509 11141209 11147209 11147809 11148910 11149010 11149210 11149710 . 11149810 11150110 11150210 11150410 11150610 11150810 11150910 11151010 1 151110 11151211 33054310 33059310 33059510 33062810" 66075211' 66076711 66077111 66078011 66079911 6608391'1 66084611 66084811 66085011 66085211 Class II When using the "Favorites" function for saved settings, there is potential for a mismatch between displayed power and the actual power output. This may result in over or under treatment. Topcon Medical Laser Systems, Inc
Devices ProSpace Peek Implant 5 degree x 8.5 x 22 mm The device is intended for vertebral body replacement or intervertebral body fusion to aid in the surgical correction or stabilization of the spine. The Aesculap PEEK Spinal Implant System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. Part no. SN038P, batch number 51915765 Class II Aesculap Implant Systems, LLC initiated a recall of the Aesculap Prospace PEEK 5 degree Implant - 8 x 8.5 x 22 mm (SN038P) because the device is incorrectly etched with an 8 degree lordosis instead of a 5 degree lordosis. The device is labeled correctly, only the etching of the implant may be incorrect. Aesculap, Inc.
Food Dried Oregano, cut and sifted; Organic; Product of Turkey, sold in 25 lb boxes High Quality Organics, Reno, NV LOT OREO-3305638A-CS-102AB Class I High Quality Organics was notified by a customer who received a lot of oregano in October 2012, recently tested last box of the shipment and found to be positive for Salmonella. High Quality Organics, Inc.
Food Pistachios, Salted in the Shell packaged in the following configurations: 1. Gurley's Golden Recipe Natural Pistachios in 2 oz., 2.25 oz., 12 oz., 3 lb., and 25 lb; 2. Mountain Country Natural Pistachios, in 2. 25 oz., and 3.5 oz.; 3. Rachael's Natural Pistachios in 2 oz. Best by dates between 02-26-14 to 06-03-14 Class I One of our vendors, ARO Pistachio Inc., is issuing an FDA Class 2 Voluntary Recall on certain shipments of pistachios. Hearthside Food Solutions LLC
Drugs Sodium Chloride Injection, USP, 0.9%, 20 mL Single-dose Fliptop Plastic Vial, packaged in 25 vial Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4888-20. Lot #: 15-058-DK*, Exp 1MAR2014; note the * may be followed by 01 Class II Presence of Particulate Matter: Confirmed customer report of visible particulate in the form of an orange or rust colored ring embedded in between the plastic layers of the plastic vial. Hospira Inc.
Drugs Oxycodone and Acetaminophen Capsules, USP 5mg/500 mg, packaged in a)100-count bottle (NDC 0591-0737-01), b) 500-count bottle (NDC 0591-0737-05), Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA92880. Lot # a) 444971A, Exp 8/13; b) 444973A, Exp 8/13 Class III Subpotent drug: Two lots of Oxycodone and Acetaminophen Capsules, USP 5/500 mg are being recalled due to low out of specification (OOS) assay result obtained at expiry (24 months) for the oxycodone portion of the product. Watson Laboratories Inc
Drugs ALCOHOL FREE ANTISEPTIC (cetylpyridinium chloride) Mouth Rinse, 0.07%, mint, 33.8 FL OZ (1 L) bottle, Distributed By The Kroger Co., Cincinnati, OH 45202, UPC 0 41260 33606 5. Lot #: 0185828, Exp 12/14 Class III Microbial Contamination of Non-Sterile Products: This product is being recalled because a stability sample was found to be contaminated with Burkholderia contaminans. Vi-Jon, Inc.
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