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U.S. Department of Health and Human Services

Enforcement Report - Week of September 25, 2013

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Platelets Pheresis Leukocytes Reduced 09FC13758 (3 units), 09FC13780 (2 units) Class III Blood products, for which a platelet count was not performed, were distributed. American Red Cross Blood Services
Biologics Red Blood Cells Leukocytes Reduced 0623626 Class III Blood products, prepared without additive (Optisol), were distributed. Community Blood Bank, Inc.
Biologics Red Blood Cells Leukocytes Reduced 09FF37204; 09V58759; 09V78804; 09V96002 Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. American Red Cross Blood Services
Biologics Red Blood Cells Leukocytes Reduced 11GC73265 Class II Blood product, incorrectly labeled as negative for the Jka red cell antigen, was distributed. American Red Cross Blood Services
Biologics Red Blood Cells Leukocytes Reduced 007GQ16444; 007GQ16445 Class III Blood products, collected using an expired blood collection set were expired, were distributed. American National Red Cross (The)
Biologics Blood and Blood Products for Reprocessing 007GQ16444; 007GQ16445 Class III Blood products, collected using an expired blood collection set were expired, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced GR76222; LR12974; LY72837 Class III Blood products, which were not prepared in accordance with specifications, were distributed. San Diego Blood Bank
Biologics Red Blood Cells KE33890 Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. San Diego Blood Bank
Biologics Fresh Frozen Plasma 0141299 Class III Blood product, in which an extended collection time for FFP, was distributed. Childrens Hospital Los Angeles
Biologics Platelets Pheresis Leukocytes Reduced Irradiated 3532562 Class II Blood product, which did not meet the acceptable product specifications, was distributed. Community Blood Bank, Inc.
Biologics Fresh Frozen Plasma 3532823; 3537422 Class II Blood products, collected from a donor with a history of Hepatitis, were distributed. Community Blood Bank, Inc.
Biologics Red Blood Cells Leukocytes Reduced 3532823 Class II Blood products, collected from a donor with a history of Hepatitis, were distributed. Community Blood Bank, Inc.
Biologics Red Blood Cells Leukocytes Reduced Irradiated 3537422 Class II Blood products, collected from a donor with a history of Hepatitis, were distributed. Community Blood Bank, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 16GK11041(Part A); 16GK11041(Part B) Class II Blood products, in which quality control and distribution of products did not meet specifications, were distributed. American National Red Cross (The)
Biologics Red Blood Cells H50513 Class II Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed. San Diego Blood Bank
Biologics Red Blood Cells Leukocytes Reduced 0616000 Class II Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. Community Blood Bank, Inc.
Biologics Source Plasma 07JTN10479; 07JTN11037; 07JTN11121 Class II Blood products, collected from a donor who was previously HIV-1/2 reactive, were distributed. BioLife Plasma Services L.P.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 110024204;110024208;110024213;110024214;110024348;110024355;110024604;110024609;110024620;110024633;110024959;110026496;110027061;110027089;110027108;110027121;110027126;110027140;110027147;110027666;110027831;114492112;114492120;114492122;114492548;114492553;114492563;114492675;114493511;114493516;114493520;114493865;114493950;114493968;114493971;114493977;114493981;114495337;114495620;114495628;114495630;114495634;114495698;114495701;114495704;114495706;114496197;114497529;114497538;114498443;110024204;110024213;110024214;110024348;110024355;110024604;110024617;110024620;110024633;110024637;110024959;110026496;110027061;110027089;110027108;110027121;110027126;110027140;110027147;110027666;110027831;114492112;114492120;114492122;114492548114492553;114492563;114492675;114493511;114493516;114493865;114493950;114493968;114493977;114493981;114495337;114495628;114495630;114495634;114495698;114495701;114495704;114495706;114496197;114497529;114497538;114498443; Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. Blood Systems, Inc.
Biologics Blood and Blood Products for Reprocessing 110026491(Part A); 110026491(Part B); 110026496; 10026498 Class III Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. Blood Systems, Inc.
Biologics Red Blood Cells Leukocytes Reduced 110024634;110024951;110027094;110027677;114492681;114493518;114493859;114493975;110024637;114493870;114493870;110024346;110024353;110024611;110024624;110024625;110024628;110024641;110024644;110024955;110024957;110024961;110024966;110025100;110025349;110025360;110026485;110026486;110026490;110026494;110026502;110026506;110026507;110026512;110026513;110026821;110026825;110026838;110026845;110027152;110027649;110027655;110027658;110027660;110027669;110027672;110027678;110027683;110027817;110027820;110027827;110027836;110027888;110028273;114482672;114492113;114492123;114492545;114492556;114492566;114492570;114492574;114492576;114492685;114493509;114493512;114493523;114493525;114493527;114493856;114493857;114493867;114493872;114493873;114493899;114493901;114493953;114493957;114493961;114493963;114493979;114493986;114495340;114495342;114495344;114495347;114495350;114495352;114495359;114495662;114495673;114495680;114495684;114495694;114495695;114495697;114495707;114497533;114497542;114497544;114498316;114498318;114498320;114498323;114498442;114498446;114498448;114498451;114498764;114498768;114492110 Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. Blood Systems, Inc.
Biologics Fresh Frozen Plasma 110024208;114493971;110024208;114493971;110024611;110024624;110024625;110024628;110024634;110024955;110025100;110026494;110026838;110026845;110027649;110027655;110027677;110027678;110027833;114493512;114493527;114493953;114493957;114495340;114495342;114495347;114495662;114497533;114498448;1144925620;110024350;110024641;110024644;110024966;110026486;110026490;110026502;110026507;110026513;110027568;110027660;110027669;110027672;110027683;114482672;114492110;114492545;114492556;114492566;114492574;114492685;114493509;114493518;114493523;114493525;114493856;114493857;114493859;11493867;114493872;114493873;114493899;114493901;114493961;114493963;114493975;114493979;114493986;114495350;114495352;114495359;114495673;114495680;114495684;114495694;114495695;114495697;114497542;114497544;114498316;114498318;114498320;114498323;114498768;114492123;114492570;114492576;114492681;114495344;114495707;114498764 Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. Blood Systems, Inc.
Biologics Red Blood Cells Leukocytes Reduced 02GJ05218;02GJ05251;02E32153;02GJ05203;02K09857; 02GJ05235;02K09839;02GJ05204;02GJ05207;02GJ05201; 02FE46227;02K09807;02GJ05241;02GJ05216;02FZ28706; 02GJ05202;02FE46218;02FE46208;02K09834;02GJ05242; 02GJ05244;02FE46253;02FE46223;02K09806;02K09841; 02K09836;02FE46255;02FE46249;02FE46222;02GJ05211; 02GJ05248;02K09819;02FE46246;02FE46252;02FZ28710; 02GJ05205;02FE46229;02FE46220;02FE46221;02FE46232; 02FE46213;02FE46236;02FE46216;02K09884;02K09818; 02K09810;02K09815;02K09870;02GJ05181;02FE46237; 02K09845;02K09844;02K09887;02GJ05196;02GJ05186; 02GJ05179;02FE46174;02GJ05221;02GJ05236;02GJ05214; 02K09879;02FE46193;02K09816;02K09792;02GJ05213; 02GJ05185;02K09804;02K09862;02K09871;02FZ28708; 02FZ28713;02GJ05280;02GJ05188;02GJ05194;02GJ05233; 02GJ05231;02K09787;02GJ05229;02GJ05224;05GJ05212; 02GJ05228;02GJ05215;02GJ05226;02GJ05232;02K09786; 02K09785;02K09780;02K09803;02GJ05239;02K09782; 02GJ05240;02K09783;02K09808;02K09797;02FE46257; 02FE46241;02FE46256;02FE46250;02FE46239;02FE46243; 02FE46238;02FZ28709;02FZ28704;02FZ28712;02GJ05190; 02GJ05206;02GJ05189;02GJ05184;02FE46198;02FE46189; 02FE46195;02FE46190;02FE46196;02FE46206;02FE46201; 02FE46187;02FE46192;02FE46197;02FE46204;02FE46224; 02FE46210;02FE46211;02FE46254;02FE46217;02FE46233; 02FE46248;02K09880;02K09881;02K09883;02K09885; 02K09856;02K09852;02K09863;02K09875;02FE46180; 02K09811;02K09795;02K09828;02K09835;02K09843; 02K09850;02K09793;02K09798;02K09809;02K09860; 02K09865;02K09858;02K09876;02FE46181;02FE46172; 02FE46183;02E32152;02FE46168;02FE46178;02K09822; 02K08848;02K09833;02K09825 Class III Blood products, in which viral testing/testing performed, interpreted, or documented incorrectly, were distributed. American Red Cross Blood Services
Biologics Red Blood Cells Leukocytes Reduced Irradiated 02FE46203; 02FZ28716; 02FE46205; 02FE46194; 02E32155; 02K09826; 02K09836 Class III Blood products, in which viral testing/testing performed, interpreted, or documented incorrectly, were distributed. American Red Cross Blood Services
Biologics Source Plasma 0460024213 Class III Blood product, in which donor donated without an acceptable arm check, was distributed. Octapharma Plasma Inc
Biologics Source Plasma 07CIAM3734, 07CIAM3038, 07CIAM2132 Class II Blood products, collected from a donor with a history of hepatitis and fatty liver disease, were distributed. BioLife Plasma Services L.P.
Biologics Source Plasma 4270132248;4270130600;4270128882;4270127841; 4270126989;4270126289;4270125004;4270124398 ;4270119210;4270118499;4270117695 Class II Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed. Csl Plasma Inc
Biologics Red Blood Cells Leukocytes Reduced 9312189; 3502491 Class II Blood products, which were collected from a donor who traveled to malarial endemic areas, were distributed. Community Blood Bank, Inc.
Biologics Source Plasma 0530546029, 0530545681, 0530542822, 0530542328, 0530540867, 0530540564, 0530539531, 0530539185, 0530537708, 0530536769, 0530536312, 0530533622, 0530533283, 0530532387, 0530531990, 0530530965, 0530530556, 0530529630, 0530529182, 0530528280, 0530526014, 0530525450, 0530521176, and 0530520099. Class II Blood products, collected from a donor whose physical was overdue, were distributed. ZLB Bioplasma, Inc.
Biologics Source Plasma 0481274943, 0481267845, 0481260767, 0481259656, 0481257087, 0481256095, 0481253621, 0481252570, 0481249963, 0481246361, 0481245224, 0481240119, 0481239505, 0481235759, 0481234613, 0481228709, 0481227587, 0481225159, 0481224060, 0481220020, 0481215883, 0481211480, 0481210598, 0481200573, 0481198622, 0481197773, 0481193693, 0481191387, 0481189545, 0481187521, 0481184717, 0481183479, 0481172823, 0481164378, 0481161825, 0481159788, 0481158377, 0481156112, 0481155099, 0481152754, 0481151615, 0481147022, 0481144721, 0481141576, 0481139054 Class II Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed. CSL Plasma, Inc.
Biologics Source Plasma 5250010874, 5250010311, 5250010319, 5250010332, 5250013674, 5250011148, 5250011158, 5250011547, 5250004906, 5250011379, 5250006860, 5250011267, 5250014217, 5250014231, 5250014243, 5250012599, 5250009582, 5250011738, 5250010341, 5250011825, 5250011786, 5250011956, 5250012050, 5250012107, 5250008037, 5250012123, 5250012160, 5250012173, 5250012239, 5250012305, 5250012307, 5250013184, 5250012247, 5250012194, 5250012196, 5250012394, 5250012351, 5250012456, 5250012471, 5250012687, 5250012522, 5250012552, 5250012556, 5250012577, 5250012518, 5250012549, 5250001560, 5250012397, 5250012692, 5250012489,  ...
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Class II Blood products, collected from donors who did not have a complete physical examination, were distributed. Octapharma Plasma Inc
Biologics Platelets Pheresis Leukocytes Reduced, Apheresis 0747488A ;0747488B ; 07474888C; ; 0748326A; 0748326B; 0748804A ; 0748804B; 0748804C; 0749147B; 0749451A; 0749451B; 749451C; 0749736A; 0749736B; 0749736C; 0749987A; 0749987B; 0749987C; 0750284C; 0750578A; 0750578B; 0750578C; 0750898A; 0750898B; 0750898C; 0752017A; 0752017B; 0752301A, 0752301C; W313710000269A, ; W313710000269B; W313710000269C; W313710000963A; W313710000963B; W313710001251A; W313710001251B; W313710001251C; 0751390A, 0751390B Class II Blood products, collected from a donor who traveled to a malarial endemic area, were distributed. HemaCare Corporation
Biologics Platelets Pheresis Leukocytes Reduced Irradiated 0750284A, 0750284B, 0751390C, 0752017B, W313710000679 (A), W313710000679(B), W313710000963 (C), W313710001522 (A), W313710001522 (B), W313710001522 (C), W313710001794 (A), W313710001794 (B), W313710001794 (C), W313710002071 (A), W313710002071 (B), W313710002071 (C). Class II Blood products, collected from a donor who traveled to a malarial endemic area, were distributed. HemaCare Corporation
Food Round Fresh Tomatoes sold in bulk boxes, 20 lbs X0198972 and X0198992 Class II The product has the potential to be contaminated with E. coli 0157: H7. Combs Produce
Devices Laserworld RGB & Piko Nano RGB Models All models are laser light show projectors, and will be used as such. All projectors distributed between 2008 and 2012, including, but not limited to, the Proline Series AG, Revolution Series AG, Club Series AG, Clus Series, Pure Light Series, and Revolution Series AG Class II A potential lack of certification, and/or missing laser certification, laser safety warning and administrative labels, and potentially incomplete Performance Feature set and incomplete User Information were discovered. Laserworld Usa Inc
Biologics Blood and Blood Products for Reprocessing 011KY66486; 011LE71292; 011KY66745; 011LE68827; 011LE70329; 011LE70832; 011LQ02672; 011KY64773; 011LQ02901; 011LQ03187; 011KY64845; 011LQ03187; 011KY64848; 011KJ37754; 011KY65293; 011KV56889; 011LE71387; 011KV59977; 011LE71394; 011LE72400; 011KY63701; 011KV61312; 011KV62180; 011KY62963; 011LF36310; 011KY64269; 011KY64604; 011LQ02646; 011KY64765;011LQ03311; 011LQ03491; 011LQ03787; 011LQ04265; 011LQ04536; 011LQ05475; 011LQ05503; 011LQ05946; 011LQ06027; 011LQ06030; 011LQ06076; 011LQ06077; 011LQ06080; 011LZ52645; 011LZ53104; 011LZ53114; 011LZ53485; 011LZ53546 Class III Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. American Red Cross Blood Services
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 011KV59414; 011KV59414 Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. American Red Cross Blood Services
Biologics Red Blood Cells Leukocytes Reduced 011KY66486; 011KY66463; 011LE71292; 011KY66745; 011LE68827; 011LE69759; 011LE70329; 011LE70832; 011LQ02672; 011KY64773; 011KY64845; 011LQ03311; 011KY64848; 011KJ37754; 011KY65293; 011KM56639; 011KY65726; 011KV56889; 011KV59977; 011LE71387; 011KY63082; 011KV59981; 011LE71394; 011KY63094; 011KV60728; 011LE71794; 011KY63689; 011KV61312; 011LE72400; 011KY63701; 011KV62180; 011LE72407; 011KY64233; 011KY62963; 011LE73137; 011KY64249; 011KV57065; 011LE73145; 011KY64257; 011KV58986; 011LF36310; 011KY64269; 011KV59001; 011LQ02582; 011KY64604; 011LQ02646; 011KY64765; 011KV59969; 011KE96885 011LQ03424; 011LQ03491;  ...
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Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. American Red Cross Blood Services
Biologics Plasma Frozen 011LE69759; 011KY66463; 011KM56639; 011KY65726; 011KV59969; 011KY63082; 011KY63094; 011KV59981; 011LE71794; 011KY63689; 011KV60728; 011LE72407; 011KY64233; 011LE73137; 011KY64249; 011LE73145; 011KY64257; 011KV57065; 011KV58986; 011LQ02582; 011KV59001; 011KE96885 Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. American Red Cross Blood Services
Devices Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-300ES and 621-400ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets. Model number: 621-300ES and 621-400ES. Multiple serial numbers affected. Class I This notice is being provided in follow up to the field correction initiated by B. Braun Medical Inc. on August 26, 2011 due to an issue in which the Outlook ES Safety Infusion System may halt infusion but the "RUN" Light Emitting Diodes (LEDs) on the front display continue to advance as if the pump were infusing. The pump emits a backup alarm, but there are no visual indicators that the infusion has stopped. The issue can potentially be observed in some Outlook ES pump models 300ES and 400ES with Compact Flash card. It is possible that under infusion could occur because the user may see a visual indication that the pump is running when it is not. B. Braun Medical Inc. has identified that not all of the affected Outlook ES pumps were listed in the original notification of this field correction. Although these pumps were not identified in the previous notice, these pumps were upgraded, if available, during field services. B Braun Medical, Inc.
Biologics Cornea 120442OSCN Class II Human Cornea, not tested to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, was distributed. Rochester Eye and Human Parts Bank, Inc.
Devices Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 420MM-Sterile. Orthppedic implant device. Part Number 450.851S, Lot Number 7065061 Class II Firm discovered that a nail that was within the scope of a previous Trauma Nail recall had been distributed. Synthes USA HQ, Inc.
Drugs SPIRIVA HandiHaler (Tiotropium Bromide Inhalation Powder) Capsules 18 mcg per dose, Rx only, a) 10 count blister (NDC 0597-0075-27), b) 30 count blister (NDC 0597-0075-41), c) 90 count blister (NDC 0597-0075-47), d) 5 count blister physician sample (NDC 0597-0075-75), Manufactured by: Boehringer Ingelheim (BI) Pharma, GmbH & Co. KG, Ingelheim, Germany Lot Number/Exp. Date: 202477A/Sep-13, 202480A/Sep-13, 202556B/Sep-13, 202603A/Sep-13, 202784B/Sep-13, 202844A/Sep-13, 202951A/Sep-13, 203041A/Sep-13, 203042A,Sep-13, 203280A/Oct-13, 203281A/Oct-13, 203364A/Oct-13, 203440A,Oct-13, 203569B/Oct-13, 203588A/Oct-13, 203890B/Nov-13, 204094A/Nov-13, 203660A/Nov-13, 203690A/Nov-13, 203890A/Nov-13, 203980A/Nov-13, 203981B/Nov-13, 204356B/Dec-13, 204357A/Dec-13, 204821A/Dec-13, 204459A/Dec-13, 204552C/Dec-13, 204822A/Dec-13, 204944A/Jan-14, 204947A/Jan-14, 205015A/Jan-14, 205163A/Jan-14, 205364A/Jan-14, 205509A/Feb-14, 205737A/Feb-14, 205571A/Feb-14, 205572A/Feb-14, 205674A/Feb-14, 205682A/Feb-14, 205959A/Feb-14, 205987A/Feb-14, 206186B/Mar-14, 206311A/Mar-14, 206606A/Mar-14, 206944B/Apr-14, 207066A/Apr-14, 206609A/Apr-14, 206729A/Apr-14, 206899A/Apr-14, 206900A/ Apr-14, 207065B/Apr-14, 207191A/May-14, 207199A/May-14, 207352A/May-14, 207420A/May-14, 207577B/May-14, 207691A/May-14, 207692A/May-14,  ...
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Class III Presence of Foreign Substance: This recall is being conducted due to the potential for extrinsic foreign particles in the API used to manufacture SPIRIVA Handihaler Boehringer Ingelheim Roxane Inc
Biologics Source Plasma BQ146535; BQ146340; BQ146127; BQ145624; BQ145539; BQ144250; BQ143866; BQ143646; Class III Blood products, collected from an ineligible donor, were distributed Plasma Biological Services
Biologics Source Plasma 12MKED1461; 12MKED0897; 12MKED0578; 12MKEC9948; 12MKEC9702; 12MKEC9401; 12MKEC9084; 12MKEC8710; 12MKEC8381; 12MKED1221; Class III Blood products, collected from an ineligible donor, were distributed. Interstate Blood Bank, Inc. of Wisconsin
Biologics Fresh Frozen Plasma W241213500713; W241212200249; Class II Blood products, collected from a donor who reported testing positive for hepatitis, were distributed Wellmont Health System Dba Marsh Regional Blood Center
Biologics Red Blood Cells Leukocytes Reduced W241212200429; ; Class II Blood products, collected from a donor who reported testing positive for hepatitis, were distributed Wellmont Health System Dba Marsh Regional Blood Center
Biologics Blood and Blood Products for Reprocessing W241211501914; W241212200429; W241212200760; W241212200943; Class III Blood products, collected from a donor who reported testing positive for hepatitis, were distributed Wellmont Health System Dba Marsh Regional Blood Center
Biologics Platelets Pooled Leukocytes Reduced Irradiated W120613380530; Class II Blood product, which did not meet the acceptable product specification for release, was distributed. Michigan Blood
Biologics Red Blood Cells W116512721632Y; W1165125034825; W116512503382D; Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed Ogden Medical Center, Inc.
Biologics Red Blood Cells Leukocytes Reduced W1165115028930; Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed Ogden Medical Center, Inc.
Biologics Source Plasma JK0443489; JK0449951; JK0450409; JK0451626; JK0451960; JK0459403; JK0459850; JK0460471; JK0460935; JK0461584; JK0462093; JK0464244; JK0464515; JK0417096; Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed DCI Biologicals, LLC
Biologics Cornea 130051100; 130051200 Class II Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. Midsouth Eye Bank for Sight Restoration Inc
Biologics Tendon Donor ID: 101082885; Serial Numbers: 8519769, 8519770, 8519771, 8519772, 8519773, 8519776, 8519777 Class III Human tissue allografts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. RTI Biologics, Inc.
Biologics Bone Donor ID 101082885; Serial Numbers: 7838730, 7838732, 7838733, 7838734, 7838735, 7838736, 7838737, 7838738, 7838739, 7838740, 7838741, 7838742, 7838743, 7838744, 7838745, 7838746, 7838747, 7915488, 7915489, 7915490, 7915491, 7915492, 7915493, 7915494, 7915495, 7915496, 7915497, 7931192, 7931193 Class III Human tissue allografts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. RTI Biologics, Inc.
Biologics Tendon Donor ID 101084060; Serial Numbers: 8464116, 8464117, 8464118, 8464120, 8464121, 8464122 Class III Human tissue allografts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. RTI Biologics, Inc.
Biologics Bone Donor ID - 101084060; Serial Numbers: 7841388, 7841389, 7841390, 7841391, 7841392, 7841393, 7841394, 7841395, 7841396, 7841397, 7841398, 7841399, 7843050, 7843051, 7843052, 7843053, 7843056, 7843057, 7843058, 7843059, 7843060, 7843061, 7843062, 7843063, 7843064, 7843065, 7843066, 7843067, 7844245, 7844246, 7844247, 7844248, 7844249, 7844250, 7844251, 7844252, 7844253, 7844254, 7844255, 7844256, 7844257, 7844258, 7844259, 7844260,  ...
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Class III Human tissue allografts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. RTI Biologics, Inc.
Devices Responder 5 is a nurse call communication system that connects patients with staff in a hospital. The nurse call system also connects team members and departments from radiology, physical therapy, transport, environmental services and more. Responder 5 is used in hospitals and long term patient care facilities to allow for remote communications between patients and patient monitoring devices and healthcare providers 1) Product Code 351000 (Branch Regional Controller); 2) Product Code 352000 (Corridor Light); 3) Product Code 352020 (Domeless Controller) Class II A counterfeited electronic component was identified in the products affected. The component, a data transceiver (transmitter/receiver), is associated with the intercommunication of these devices in the Responder 5 system across the L-Net data path. Failure of a data transceiver results in the loss of nurse call functionality in the associated room, and may disrupt communications on the L-Net run, affecting nurse call communications across multiple rooms. Rauland-Borg Corp
Devices Brilliance CT 6, M/N 728256; Brilliance CT 16 M/N 728246; Brilliance CT 40, M/N 728235 & Brilliance CT 64 M/N 728231, Philips Healthcare, Cleveland, OH 44143. Intended to produce cross-sectional images of the body by computer reconstruction. Model #, 728231, Serial #: 4021, 9535, 9544, 9587, 9627, 9701, 9707, 9713, 9759, 9875, 9887, 9917, 9925, 9931, 9980, 9996, 10009, 10011, 10012, 10015, 10028, 10036, 10042, 10045, 10050, 10052, 10062, 10063, 10064, 10077, 10079, 10081, 10096, 10099, 10102, 10111, 10114, 10120, 10122, 10135, 10136, 10137, 10139, 10145, 10148,  ...
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Class II The patient support may move in an unintended manner if the footswitch cover impinges on the footswitch. Philips Medical Systems (Cleveland) Inc
Food Frozen Hot Smoked Vacuum Packed Salmon Batch number 71013 (this represents the production date) Best by date is 12/10/13 Class II Frozen Hot Smoked Vacuum-Packed Salmon packaged in 1.5 lb packages is being recalled due to missing information on the label. Specifically, "Important: Keep Frozen Until Used. Thaw under Refrigerated immediately before use". Failure to provide instructions on the label for proper storage and handling of the product can cause Clostridium botulinum to grow and produce toxin. Mike's Quality Meats, Inc.
Devices ACL TOP (Base); PN 0000280000 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters. Nov 2003 - Nov 2011, Serial Numbers 02110101 through 11111174 Class II Potential carryover issue that can can cause shortened APTT clotting times on the instrument. Instrumentation Laboratory Co.
Devices ACL TOP 700; PN 0000280010 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters. Start SN and Date: 09080100, Aug 2009 End SN and Date: 13070559, July 2013 Class II Potential carryover issue that can can cause shortened APTT clotting times on the instrument. Instrumentation Laboratory Co.
Devices ACL TOP CTS; PN 0000280020 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters. Start SN and Date: 06020101, Feb 2006; End SN and Date: 10080662, Aug 2010 Class II Potential carryover issue that can can cause shortened APTT clotting times on the instrument. Instrumentation Laboratory Co.
Devices ACL TOP 700 LAS; PN 0000280030 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters. Start SN and Date: 08120100, Dec 2008; End SN and Date: 13070172, July 2013 Class II Potential carryover issue that can can cause shortened APTT clotting times on the instrument. Instrumentation Laboratory Co.
Devices ACL TOP 700 CTS; PN 0000280050 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters. Start SN and Date: 09120101, Dec 2009; End SN and Date: 13070304, July 2013 Class II Potential carryover issue that can can cause shortened APTT clotting times on the instrument. Instrumentation Laboratory Co.
Devices ACL TOP 300 and ACL TOP 300 CTS (Japan); PN 0000280060 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters. Start SN and Date: 12060256, Jun 2012; End SN and Date: 13070837, July 2013 and Start SN and Date: 11120131J, Dec 2011; End SN and Date: 13060320J, Jun2013 Class II Potential carryover issue that can can cause shortened APTT clotting times on the instrument. Instrumentation Laboratory Co.
Devices ACL TOP 500 CTS; PN 0000280040 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters. Start SN and Date: 08010100 Jan 2008 - 13072599 July 2013 Class II Potential carryover issue that can can cause shortened APTT clotting times on the instrument. Instrumentation Laboratory Co.
Food Liquid Yeast Cream, Bulk, in tanker truck quantities, refrigerated 33F-45F Bulk production lots: 189A13842B 189A79022B 188A79021B 188A79021B 189A79022B 189A79022B 189A79022B 189A79022B 188A13831B Class II Bulk liquid yeast is contaminated with Salmonella. American Yeast Corporation
Devices DiaScreen Liquid Urine Controls: Positive and Negative Assayed Liquid Quality Controls for use with Dipsticks in Routine Urinalysis; Product Number D76004 (4x12 mL bottles) consists of: 2x12mL Positive controls [and] 2x12mL Negative controls; Manufactured for ARKRAY USA, Inc.; Minneapolis, MN 55439 Diascreen liquid urine control is a synthetic control designed to react with commercial urine dipsticks to register listed responses on color reagent pads. It is intended for use in a clinical laboratory as a urine control for qualitative procedures used in chemical determinations. The control is intended to be used exactly as if it were a patient sample to assist in the assessment of the listed analytical procedures. Product Number: D76004; Lots: All Lots; Independence Medical Catalog Number: CJD76004 Class II The products may have been stored at temperatures outside their required storage conditions. Assuramed
Devices Hemoccult II BRAND SENSA elite; MATERIALS AND REAGENTS; Hemoccult II SENSA elite Slides (Test Cares) containing guaiac paper; Hemoccult SENSA Developer-a developing solution containing a stabilized mixture of less than 4.2% hydrogen peroxide, 80% denatured ethyl alcohol and enhancer in an aqueous solution; Applicator Sticks; Patient Screening Kit Dispensing Envelopes with Patient Instructions; Flushable Collection Tissues; Mailing Pouches (for returning completed Test Cares); Hemoccult II SENSA elite Product Instructions; Beckman Coulter, Inc.; 250 S. Kraemer Blvd.; Brea, CA 92821 The Hemoccult II SENSA elite test is a rapid, convenient and qualitative method for detecting fecal occult blood which may be indicative of gastrointestinal disease. It is not a test for colorectal cancer or any other specific diseases. The Hemoccult II SENSA elite test is recommended for professional use as a diagnostic aid during routine physical examinations, for hospital patients to monitor for gastrointestinal bleeding in patients with iron deficiency anemia or recuperating from surgery, peptic ulcer, ulcerative colitis and other conditions, and in screening programs for colorectal cancer when the Patient Instructions are closely followed. Serial fecal specimen analysis is recommended when screening symptomatic patients. The Hemoccult II SENSA elite test and other unmodified guaiac tests are not recommended for use with gastric specimens. Product Number: 9964130; Lots: All Lots; Independence Medical Catalog Number: 9964130 Class II The products may have been stored at temperatures outside their required storage conditions. Assuramed
Devices ProTime Microcoagulation System; PROTIME CUVETTE AND PROTIME3 CUVETTE; Store the foil-pouched cuvettes refrigerated 2-8C (36 - 36F); MATERIALS PROVIDED; ProTime cuvettes with Tenderlett Plus; or; Protime3 cuvettes with Tenderlett Plus LV; Product Instructions; Antiseptic, gauze (with self-test package only); International Technidyne Corporation; 8 Olsen Avenue; Edison, NJ 08820 USA; a subsidiary of Thoratec Corporation The ProTime Microcoagulation System consists of a portable, battery operated instrument and disposable cuvette for quantitative determination of prothrombin time (PT) from fingerstick whole blood or anticoagulant-free venous whole blood. There are two different types of cuvettes available for use with the ProTime Microcoagulation System: a ProTime cuvette and a ProTime3 cuvette. The ProTime cuvette is black color coded and utilizes three channels for the PT assays and two channels for integral controls. It requires approximately 65 ul of blood (approximately 3 drops). The ProTime3 cuvette is blue color coded and utilizes one channel for PT assay and two channels for integral controls. The ProTime3 cuvette requires approximately 27 ul of blood (approximately 1 large drop). The ProTime Microcoagulation System is intended for professional use in the management of patients treated with oral anticoagulants or for patient self-testing. *** 1) Product Number: PRO3-25; Lots: All Lots; Independence Medical Catalog Number: 55L2101002; *** 2) Product Number: PRO5-25; Lots: All Lots; Independence Medical Catalog Number: ICPRO525 Class II The products may have been stored at temperatures outside their required storage conditions. Assuramed
Food "***SUPERPAN***Tu Pan Natural***" 3107291300, 3107301300, 3107311300, 3108011300, 3108031300, 3208051300, 3208061300, 3208971300, 3208081300, 3208091300 Class II Undeclared allergens: wheat. The list of ingredients declare "semolina durum" but not the common name "wheat". Lucy's Kitchen, Inc.
Food "***SUPERBUDIN" No codes Class II Undeclared allergens: wheat. and soy One of the ingredients is "Super Pan" that contains wheat as a sub-ingredient. The coconut milk is another ingredient that contains "soy lecithin" and it is undeclared. Lucy's Kitchen, Inc.
Devices VisuALIF,System consisting of a 'U' shaped PEEK block in two footprint configurations, four heights and three lordosis angles., part number: 0301-1410. Intended to be implanted via an open anterior approach. Part Number: 0301-1410, Lot 53AR Class II The product has the potential to be laser marked as a Medium when it actually is a Small. Spine Smith Holdings, LLC
Food Frozen dough balls are sold under brand name Winco or Tasty Bake: Item # 04018 is 17 oz wheat dough ball, Winco brand, individually wrapped in plastic bag with label for retail use, UPC 0 31693 04018 9; Item # 00518 is 17 oz white dough ball, Winco brand, individually wrapped in plastic bag with label for retail use, UPC 0 31693 00518 8; Item # 00520 is Tasty Bake original 20 oz dough ball, BULK packed with 30 individual plastic bags per case for food service use,UPC 0 31693 00520 1; Item # 00525 is Tasty Bake original 25 oz dough ball, BULK packed with 24 individual plastic bags per case for food service use, UPC 0 31693 00525 6; Item # 00530 is Tasty Bake original 30 oz dough ball, BULK packed with 20 individual plastic bags per case for food service use,UPC 0 31693 00530 0. The Winco's label is read in parts: "***Pizza Dough***Roll out crust to desired size***Top with favorite toppings***Baked at 400F for 15 to 20 minutes or until golden brown***". The Cooking instructions is labeled in parts: "***CRUST & DOUGH HANDLING***DOUGH BALLS***Cooking Guidelines for Dough Balls***Deck***Oven Temp 450-475F***Cook time 12-18 minutes****Conveyor***Oven Temp 500F***Cook time 5-9 minutes***Convection***Oven Temp 400-425F***Cook time 7-12 minutes***Tasty Bake, Inc.***1945 8th Street***Baker City, OR 97814***(800) 753-2112***(541) 523-5323***Fax: (541) 523-4764*** Julian Dates 213-220 It interprets that product was made on August 1 through August 8. Class II Frozen dough ball was processed with Baker City (Oregon) water and it has a potential to be contaminated with Cryptosporidium. The Boil Water Notice was issued on 7/31/13 by Baker County and Baker City officials in Oregon Tasty Bake Inc
Devices T8 REMOVAL HEAD, REF 8910641, QTY: 1 EA, Product Usage: The non-sterile T8 Removal Diriver is used with the Spire and Spire Z Spinal System in conjunction with the set screwdriver to remove the implant during removal surgery. The set screw driver is attached to the end of the removal head and used to disengage the remaining portion of the set screw within the device. RS12K008 Class II One lot of the T8 Removal Head had incorrect hardness specification, which could result in the T8 Removal head failing during removal of the CD Horizon Spire and Spire Z Spinal System implant. There is a potential for tissue damage to occur and/or minor surgical delay to remove the remaining fragments of the tip. Medtronic Sofamor Danek USA Inc
Food Benefiber, Fiber plus Calcium Supplement, Wild Berry Chewables 90ct, sugar free, chewable tablets bottle. Novartis Consumer Health, Inc, Parsippany, NJ. Lot Number and Expiration date 10118852 , 6/30/2013; 10123090, 8/31/2013; 10127095, 10/31/2014. Class III The lot number and/or expiration date may be illegible on the outer plastic bottle packaging. Novartis Consumer Health
Food Benefiber, Fiber Supplement, Orange Creme Chewables, Sugar Free, 36ct and 100ct chewable tablet bottles. Novartis Consumer Health, Inc, Parsippany, NJ. Lot Number and Expiration date (36ct bottle): 10117915, 5/31/2014; 10118335, 7/31/2014; 10120615, 9/30/2014; 10110703A 3/31/2014. (100ct bottle): 10110706, 2/28/2014; 10112140, 2/28/2014; 10113261, 5/31/2014; 10116530, 5/31/2014; 10120059, 7/31/2014; 10120616, 8/31/2014; 10125996, 9/30/2014 and 10109551, 3/31/2015. Class III The lot number and/or expiration date may be illegible on the outer plastic bottle packaging. Novartis Consumer Health
Food Benefiber, Fiber Supplement, 72ct and 114 caplet bottles. Novartis Consumer Health, Inc, Parsippany, NJ. Lot Number and Expiration date 72 ct bottle: 10100086, 9/30/2013 114 ct bottle: 10093114, 6/30/2013; 10095522, 7/31/2013; 10095531, 7/31/2013; 10097337, 8/31/2013; 10099444, 9/30/2013; 10099445, 9/30/2013; 10101260, 10/31/2013; 10102755, 11/30/2013; 10104634, 12/31/2013; 10104635, 1/31/2014; 10108857, 1/31/2014; 10112134, 2/28/2014; 10112135, 4/30/2014; 10113255, 5/31/2014; 10116304, 5/31/2014; 10118831, 6/30/2014; 10119626, 6/30/2014; 10120461, 7/31/2014; 10120462, 7/31/2014; 10124311, 9/30/2014;  ...
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Class III The lot number and/or expiration date may be illegible on the outer plastic bottle packaging. Novartis Consumer Health
Food Benefiber, Fiber Supplement, Assorted Fruit, Sugar Free, 100ct chewable tablets. Novartis Consumer Health, Inc, Parsippany, NJ. Lot Number and Expiration date 10110708, 5/12/2011; 10110806, 5/10/2011; 10111858, 6/8/2011; 10112132, 6/17/2011; 10113256, 7/25/2011; 10116303, 9/9/2011; 10116444, 9/8/2011; 10118336, 10/6/2011; 10118337, 10/6/2011; 10119374, 10/31/2011; 10119376, 10/4/2011; 10120002, 12/6/2011; 10120003, 11/1/2011; 10123092, 12/6/2011; 10123093, 11/18/2011; 10125929, 12/21/2011; 10125995, 12/21/2011; Class III The lot number and/or expiration date may be illegible on the outer plastic bottle packaging. Novartis Consumer Health
Food Benefibre, Orange Creme Chewables, 36ct and 100ct chewable tablet bottles. Foreign labeling: Novartis Consumer Health Canada Inc, Mississauga, ON. Lot Number and Expiration date 36ct bottle: 10101294, 12/31/2013; 10114155, 4/30/2014 100ct bottle: 10097346,8/31/2013;10104669,12/31/2013;10117018,1/31/2014;10117019,4/30/2014;10120625,8/31/2014; Class III The lot number and/or expiration date may be illegible on the outer plastic bottle packaging. Novartis Consumer Health
Devices Juno DRF System. Mobile X-ray system These are general, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures PN 709020 Class II It has been discovered that the Air Kerma rate information is inconsistent in Continuous Fluoro modes 30x30 (12"x12") and 15x15 (6"x6). This could result in a deviation of the displayed values of Air Kerma Rate and Cumulated Air Kerma from the actual values greater then +/-35% and then in a failure to comply with the requirements of 21 CFR 1020.32(k)(6 Villa Radiology Systems LLC
Devices Sonogage EyeScan, A-Scan Biometer, Product Usage: A-Scan Biometer diagnostic device for measurement of axial eye length. Serial #: ES10001 - ES10002, ES10004 -ES10012, ES10014 - ES10040, ES10042 - ES100167, ES10170-ES10185, ES10187 - ES10214, ES10218 - ES10224, ES10226, ES10228 - ES10230, ES10233, ES10235-ES10242, ES10244 - ES10252, ES1024-ES10426, ES10253 - ES10260, ES10262, ES10267 - ES10277, ES10279 - ES10306, ES10308 - ES10347, ES10349-ES10357, ES10359 - ES10423, ES10427 - ES10444,  ...
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Class II During an FDA inspection on 7/15-26/2013, it was discovered that the firm lacked registration and 510(k) clearance for the device. Sonogage Inc
Devices BIORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture; Part Number: 72200775 Biodegradable suture anchor 50252371, 50252817, 50252818, 50253051, 50253556, 50254393, 50255140, 50255943, 50257230, 50257886, 50258390, 50258813, 50259145, 50259748, 50259820, 50260127, 50261934, 50263317, 50263909, 50264101, 50264417, 50264775, 50265257, 50265457, 50265935, 50266338, 50266709, 50266926, 50267287, 50267297, 50267742, 50268009, 50268284, 50268801, 50269502, 50269812, 50270227, 50270716, 50271271, 50271608, 50271908, 50272544, 50273015, 50273358, 50273640, 50273933, 50274557, 50274799, 50275368, 50276253,  ...
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Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Smith & Nephew, Inc. Endoscopy Division
Devices BIORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture; Part Number: 72200774 Biodegradable suture anchor 50252956 50253511 50255944 50257231 50257887 50258391 50259146 50259750 50259821 50260686 50261428 50262956 50263219 50263661 50264102 50265258 50266339 50266927 50267570 50268569 50269026 50269813 50270372 50271272 50271909 50272355 50273934 50274664 50275118 50276255 50276806 50277167 50277785 50278253 50278900 50279470 50280271 50280510 50281120 50281481 50281875 50282158 50282541 50283320 50283827 50285048 50285421 50286293 50286609 50287487 50287743 50288414 50288712 50289363 50290038 50290548 50291351 50292241 50293608 50294169 50294378 50295261 50297038 50298069 50299385 50299683 50300671 50301473 50302325 50303059 50303150 50303787 50304658 50305102 50305723 50306820 50307460 50308223 50308654 50309005 50309760 50309927 50310434 50310774 50310860 50311917 50312590 50314382 50315219 50315411 50315799 50316169 50316263 50316662 50316990 50317055 50317280 50317454 50317458 50317464 50317995 50318784 50319133 50319545 50320231 50321239 50323634 50324606 50325731 50326560 50327214 50328866 50330833 50331688 50332902 50333546 50333779 50338800 50339831 50341603 50342909 50344379 50345301 50345318 50346210 50348330 50348512 50349830 50350260 50350691 50351144 50351956 50352210 50353153 50353605 50354092 50354530 50355121 50356403 50356622 50357089 50357390 50358104 50358384 50358570 50358737 50360444 50360805 50361888 50362229 50363185 50363892 50364660 50364943 50366146 50366306 50367859 50369187 50370318 50370807 50371620 50372061 50372503 50372895 50373328 50375326 50376603 50378048 50378139 50379043 50381196 50382147 50385218 50385487 50385823 50386382 50388029 50388738 50388904 50390494 50391246 50392389 50394523 50395091 50396670 50398546 50399426 50401028 50402074 50402820 50404404 50405090 50405697 50405889 50409820 50407935 50408209 50410766 50411053 50411900 50412271 50413139 50414779 50414982 50415491 50416313 50417008 50417522 50418330 50418858 50421496 50430179 50430392 50435315 50437094 50437346 50438202 50440209 50441677 50442744 50443592 50444060 50445031 50445515 50445520 50447262 50448595 50450276 50451218 50453799 50455193 50458413 50459732 50460345 50461686 50462370 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Smith & Nephew, Inc. Endoscopy Division
Devices BIORAPTOR 2.9 mm Suture Anchor with DURABRAID" Suture; Part Number: 72200783 Biodegradable suture anchor 50281125 50284266 50287760 50291931 50296472 50300113 50311609 50316176 50321099 50328710 50345983 50346630 50347152 50375169 50379044 50391248 50392390 50409415 50414558 50419568 50421350 50443184 50447005 50449127 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Smith & Nephew, Inc. Endoscopy Division
Devices BIORAPTOR 2.9 mm Suture Anchor Straight, pack of 2 ULTRABRAID Suture; Part Number: 72200690 Biodegradable suture anchor 50253115 50253116 50253563 50258921 50259836 50261046 50261482 50266078 50266098 50266396 50266957 50270377 50271281 50273022 50274567 50281658 50291542 50293283 50298902 50302160 50304442 50308346 50310770 50323628 50328862 50348760 50349091 50350411 50353298 50359945 50360003 50361170 50361752 50364587 50366305 50380819 50382582 50386154 50387219 50387852 50388184 50388737 50389115 50389772 50417524 50452589 50464571 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Smith & Nephew, Inc. Endoscopy Division
Devices BIORAPTOR 2.9 mm Suture Anchor, pack of 1 ULTRABRAID Suture: 72200689 Biodegradable suture anchor 50257249 50266395 50266956 50273021 50274566 50292663 50298060 50310769 50312085 50312489 50314911 50319308 50320226 50365776 50366000 50372062 50372899 50373577 50430178 50430381 50432333 50433339 50435314 50437523 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Smith & Nephew, Inc. Endoscopy Division
Devices OSTEORAPTOR 2.3 mm Suture Anchor with ULTRABRAID COBRAID Suture, Blue; Part Number: 72201993 Biodegradable suture anchor 50261071 50265227 50268236 50270124 50270127 50270731 50270732 50270944 50272331 50272463 50272751 50274143 50274349 50277106 50278834 50281659 50282211 50282825 50283848 50285062 50287130 50288422 50289369 50291056 50292247 50293722 50295044 50295954 50297046 50298435 50299024 50301146 50301385 50302078 50306608 50307181 50307859 50308888 50308912 50309137 50311191 50312587 50314102 50315238 50316441 50316664 50317482 50317875 50318971 50319908 50320248 50321101 50321648 50322088 50322930 50323639 50324385 50325610 50325737 50326879 50327995 50328245 50329009 50329813 50330435 50332245 50333093 50333956 50334115 50334402 50335321 50336229 50336882 50337043 50337449 50338243 50338995 50339833 50340161 50341063 50341287 50341846 50342910 50343441 50344016 50344263 50344619 50346628 50347009 50347537 50348331 50349439 50350189 50350979 50351681 50351959 50352540 50353155 50353497 50353607 50354099 50355298 50355824 50356121 50356985 50357105 50357560 50358205 50358555 50359713 50360281 50360451 50361177 50362090 50362645 50362978 50363189 50363545 50364184 50364663 50364910 50364911 50364912 50369681 50369960 50370096 50370209 50371913 50373322 50373580 50374378 50375175 50375582 50375896 50376045 50376616 50376834 50377164 50377317 50379208 50379388 50379938 50380822 50381057 50381374 50381815 50382801 50383513 50384164 50384951 50385489 50385824 50386925 50387321 50387880 50387895 50388430 50389103 50390008 50390942 50391228 50391627 50392267 50392391 50393196 50393760 50394180 50396181 50396831 50397271 50397460 50398372 50398722 50399414 50399815 50400186 50400942 50401453 50401757 50401920 50402611 50402824 50403368 50403711 50403712 50404421 50404748 50405574 50406025 50406508 50407109 50407568 50408211 50408883 50410215 50409543 50409822 50410771 50411055 50412025 50412274 50412888 50413142 50413774 50414255 50414556 50415255 50415495 50415667 50415868 50416318 50416532 50416826 50417010 50417205 50417523 50418332 50419700 50420159 50420854 50421718 50423590 50423955 50425117 50426327 50426461 50426940 50427506 50427629 50428458 50428810 50430183 50430401 50430506 50430507 50430658 50430659 50430660 50430661 50431124 50431125 50431126 50431237 50431238 50431383 50431385 50433042 50433340 50435317 50435735 50436891 50437525 50437584 50438203 50438660 50438927 50439573 50439897 50440453 50441440 50441678 50442126 50442378 50444664 50445032 50445140 50445313 50445546 50445547 50446664 50447263 50448058 50448322 50448831 50450467 50450753 50450948 50451767 50451782 50452211 50452586 50453147 50453807 50454296 50454419 50454689 50455196 50455484 50455814 50456055 50456612 50456911 50457054 50457927 50458417 50458476 50459149 50459444 50460099 50460241 50461693 50461911 50462227 50462795 50463367 50463459 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Smith & Nephew, Inc. Endoscopy Division
Devices OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue ; Part Number: 72201995 Biodegradable suture anchor 50272329 50272466 50274208 50274464 50274790 50275814 50277799 50278266 50278994 50282166 50283019 50283839 50285057 50286656 50288421 50289813 50291359 50293118 50294563 50295608 50296649 50298065 50301017 50302318 50305467 50306821 50308347 50309211 50310089 50310614 50311296 50312591 50314389 50315223 50315419 50316180 50316679 50316987 50317481 50318376 50318532 50319543 50320363 50321935 50323084 50323631 50324184 50324789 50327218 50331339 50333094 50336659 50339177 50340628 50343607 50345140 50345975 50347750 50349688 50352034 50352998 50354277 50354523 50356122 50356984 50357948 50358554 50360002 50360656 50361750 50362641 50363887 50364918 50367858 50368809 50370314 50371912 50374779 50375720 50376835 50377822 50379209 50381376 50384165 50385364 50386748 50387839 50388736 50390940 50392275 50393329 50394520 50395793 50397073 50399277 50400560 50401454 50402073 50403117 50403703 50404630 50406026 50407298 50408207 50408986 50409815 50410646 50411754 50413578 50414258 50415462 50416319 50417212 50418095 50418678 50420659 50422216 50428378 50429372 50429659 50430185 50430406 50433943 50435810 50436716 50437246 50438205 50438744 50440212 50440606 50441444 50443360 50443860 50444062 50445142 50445316 50445551 50445552 50445553 50445555 50445556 50447139 50448325 50449126 50450279 50451524 50452588 50452764 50453646 50454691 50455485 50456543 50458419 50458609 50460107 50460693 50463955 50464113 50465465 50468475 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Smith & Nephew, Inc. Endoscopy Division
Devices OSTEORAPTOR 2.3 mm with 1 ULTRABRAID Suture, White; Part Number: 72201991 Biodegradable suture anchor 50272333 50272460 50272749 50273092 50274145 50274574 50277104 50277531 50278113 50281660 50283022 50283200 50283850 50285450 50287132 50290044 50290336 50292248 50293720 50295817 50298408 50301689 50302077 50305597 50307616 50307617 50307618 50307663 50308924 50308925 50308926 50309406 50309508 50310779 50311755 50312497 50314731 50316178 50316439 50317760 50318970 50320251 50320672 50321643 50321930 50322929 50324017 50325608 50326698 50327820 50329812 50331690 50332905 50334815 50336529 50339426 50340626 50341618 50343004 50343606 50344261 50344616 50346627 50350512 50351012 50351958 50353154 50353603 50354094 50355980 50356986 50358573 50359120 50360006 50360806 50361757 50362646 50363764 50364908 50364913 50364914 50370384 50372334 50372727 50372893 50374260 50375049 50375595 50378705 50378911 50379639 50380393 50380529 50383897 50384594 50385078 50385697 50387883 50388027 50388266 50389118 50390497 50392265 50394521 50395089 50395537 50397272 50397703 50399280 50400568 50401030 50401758 50402612 50403120 50403717 50404750 50405222 50406196 50407002 50407567 50407939 50408700 50409823 50411054 50412275 50413141 50414235 50415253 50415494 50416128 50416525 50417009 50417383 50418000 50418498 50419235 50421349 50423113 50423434 50425116 50426665 50426939 50427505 50429270 50430180 50431376 50433037 50433126 50434434 50435065 50435511 50438086 50438658 50439570 50440210 50441218 50442032 50444061 50444660 50445139 50445312 50445544 50445545 50446349 50447136 50448057 50449021 50449978 50449979 50449981 50449983 50449984 50449985 50450604 50450947 50451941 50452039 50453146 50453803 50454293 50454688 50455482 50455623 50456054 50456340 50456908 50458605 50460096 50460239 50461691 50462794 50463457 50466682 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Smith & Nephew, Inc. Endoscopy Division
Devices OSTEORAPTOR 2.3 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Black; Part Number: 72201992 Biodegradable suture anchor 50272332 50272462 50272750 50274144 50274350 50277105 50278907 50281510 50282171 50282827 50283849 50284637 50285830 50286658 50287767 50289371 50290043 50291934 50292091 50295383 50296070 50297228 50297782 50298793 50300135 50301932 50306856 50307462 50308037 50309210 50310436 50310780 50312090 50313439 50313818 50314915 50315807 50316601 50316986 50317483 50318001 50318687 50319907 50320679 50321916 50322244 50323257 50323630 50323780 50324608 50325611 50326067 50327821 50329242 50331546 50332253 50333092 50334400 50335620 50336405 50338241 50339832 50341062 50341605 50343271 50344262 50344618 50346215 50347305 50349093 50350513 50350978 50352032 50352701 50352997 50353606 50355123 50355672 50356987 50357104 50358206 50359714 50360454 50360914 50361413 50362647 50363190 50364588 50364909 50364915 50370316 50370385 50372675 50372728 50372892 50374025 50374503 50375408 50376044 50376238 50377316 50378706 50380530 50381197 50382647 50384163 50384950 50385362 50387220 50387886 50387896 50388742 50390996 50391608 50392266 50394701 50395538 50397273 50398231 50399415 50400574 50401262 50401918 50402459 50402823 50403367 50403718 50404238 50404920 50405868 50405869 50410769 50412026 50412957 50414254 50416317 50416526 50417204 50418001 50418331 50418992 50421031 50422577 50423435 50423591 50426460 50426933 50427032 50428116 50428624 50429271 50429999 50430000 50430400 50430503 50430504 50430505 50430657 50431379 50433038 50433039 50433040 50433041 50433127 50434653 50435732 50435733 50435734 50435809 50436890 50438659 50440452 50441439 50450277 50450752 50451781 50452210 50452585 50453453 50454295 50454418 50455195 50455483 50455813 50456909 50457385 50458416 50458475 50459739 50460097 50460240 50461060 50462482 50463458 50464108 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Smith & Nephew, Inc. Endoscopy Division
Devices OSTOSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Blue; Part Number: 72201994 Biodegradable suture anchor 50261490 50270751 50270752 50272328 50272465 50274463 50275816 50277797 50281885 50282824 50284636 50286043 50289368 50294562 50295821 50299025 50302162 50307324 50309971 50315070 50316291 50318787 50321649 50323781 50326576 50327051 50328246 50329605 50330164 50330433 50333202 50333957 50334241 50335882 50338130 50338996 50340050 50340627 50342110 50344240 50347147 50348649 50349265 50352033 50352702 50354093 50355668 50356988 50358386 50358575 50360455 50361180 50364371 50364916 50364917 50367984 50370095 50370386 50372674 50372726 50372891 50374024 50375338 50375718 50381375 50385219 50385825 50387844 50388265 50389117 50389773 50390998 50392274 50392409 50397270 50398235 50399412 50399967 50400564 50401261 50401755 50402841 50403705 50405380 50406766 50407937 50408210 50408987 50412272 50412887 50415149 50415668 50416533 50417385 50418091 50419236 50421032 50423918 50429649 50430508 50431561 50435318 50436414 50437095 50437757 50438661 50439575 50441219 50442379 50444209 50445033 50445549 50445550 50446028 50447137 50448059 50448721 50449649 50449999 50450468 50450949 50452587 50453337 50454420 50455626 50456613 50457636 50458477 50458757 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Smith & Nephew, Inc. Endoscopy Division
Devices OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black; Part Number: 72201996 Biodegradable suture anchor 50272330 50272467 50274209 50274465 50274791 50275815 50277800 50292667 50296071 50302316 50306994 50310605 50311297 50316179 50318681 50321243 50323086 50325048 50325601 50326880 50329010 50329811 50334408 50336660 50338997 50340629 50344015 50346092 50346624 50353156 50354524 50356989 50358564 50363890 50364919 50368628 50370206 50374882 50376601 50378711 50381816 50385513 50390999 50391628 50392410 50395539 50400939 50403274 50404746 50406677 50408208 50409818 50412886 50414333 50415150 50416320 50417391 50418417 50419567 50421499 50431562 50433945 50436052 50437097 50439085 50445036 50445557 50447140 50449470 50450754 50452349 50453811 50454844 50456056 50458436 50461697 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Smith & Nephew, Inc. Endoscopy Division
Devices OSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture, White; Part Number: 72202165 Biodegradable suture anchor 50272335 50272468 50274466 50274792 50275817 50278112 50282209 50283021 50286518 50286657 50286925 50288725 50290551 50291360 50294564 50295956 50296887 50298073 50301797 50307182 50309401 50309926 50310781 50312498 50314440 50319909 50320249 50322931 50323640 50325599 50326068 50329810 50329975 50333958 50335745 50338377 50341064 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Smith & Nephew, Inc. Endoscopy Division
Devices OSTEORAPTOR CURVED 2.3 mm Suture Anchor ULTRABRAID COBRAID Suture, Black; Part Number: 72203291 Biodegradable suture anchor 50366964 50366974 50366982 50366987 50366991 50370758 50370941 50370943 50371293 50376477 50387447 50392962 50394696 50397924 50400302 50400308 50408067 50414256 50415787 50417207 50419579 50425118 50428815 50429654 50431732 50435075 50435211 50444669 50445035 50445761 50445877 50450950 50458418 50458435 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Smith & Nephew, Inc. Endoscopy Division
Devices OSTEORAPTOR CURVED 2.3 mm Suture Anchor SA ULTRABRAID COBRAID Suture, Blue; Part Number: 72203290 Biodegradable suture anchor 50364854 50366872 50366972 50366980 50366985 50366989 50370760 50370771 50370940 50371292 50376475 50385813 50386237 50386563 50386749 50388066 50391012 50394695 50396184 50400301 50400306 50400307 50403488 50404241 50406445 50407524 50407571 50410789 50411371 50414977 50415258 50415670 50416148 50417206 50418093 50418993 50420658 50423443 50429652 50430190 50430402 50431731 50433933 50435319 50441441 50442649 50444415 50445034 50445760 50447482 50448060 50448722 50450469 50451783 50453148 50454104 50455627 50456912 50458608 50460242 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Smith & Nephew, Inc. Endoscopy Division
Devices TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue; Part Number: 72202597 Biodegradable suture anchor 50324706 50324707 50324958 50325148 50326624 50336118 50336716 50336759 50337105 50337109 50337112 50339394 50339648 50339653 50339656 50339873 50341613 50343278 50344410 50346095 50350419 50352199 50357080 50358106 50358736 50359998 50361739 50362786 50363871 50366812 50368582 50370504 50372042 50374257 50376594 50378774 50380528 50382637 50384518 50386924 50388022 50390005 50390988 50392388 50395082 50395975 50396667 50398098 50401255 50402220 50404745 50406626 50406675 50408537 50411606 50414330 50415861 50417004 50418086 50422213 50428616 50429266 50429632 50436702 50436747 50436748 50438319 50438651 50438735 50438739 50438918 50445013 50446067 50446068 50446460 50446995 50448591 50450274 50451213 50453452 50453995 50456041 50456190 50457051 50458600 50462057 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Smith & Nephew, Inc. Endoscopy Division
Devices TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202624 Biodegradable suture anchor 50324708 50325149 50326625 50336717 50337106 50339395 50339843 50341977 50344395 50348067 50349691 50350416 50352028 50353294 50354590 50356630 50358741 50360275 50362293 50363529 50368587 50371455 50374778 50376047 50379205 50382798 50385696 50387871 50388024 50390982 50392404 50395800 50400928 50403699 50405378 50408699 50410783 50415863 50417200 50418988 50429268 50429637 50429638 50429830 50430372 50431221 50438924 50439176 50439782 50440819 50442646 50442874 50446662 50447248 50448829 50449442 50449829 50450460 50451214 50452940 50453996 50456042 50456043 50456044 50456595 50458432 50458472 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Smith & Nephew, Inc. Endoscopy Division
Devices TWINFIX Ultra HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202626 Biodegradable suture anchor 50324715 50324960 50326833 50336719 50336768 50339643 50339651 50341854 50344396 50348650 50349838 50350841 50351449 50353295 50360151 50363875 50368586 50372045 50374017 50375716 50378770 50381624 50387868 50390937 50395330 50397700 50402973 50404638 50406692 50408058 50412954 50415137 50416799 50418989 50429269 50429640 50429642 50429832 50431134 50439753 50439754 50442740 50443625 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Smith & Nephew, Inc. Endoscopy Division
Devices TWINFIX Ultra HA 6.5 mm with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202631 Biodegradable suture anchor 50325165 50326838 50336722 50339646 50339844 50343443 50350417 50352981 50379206 50397701 50429644 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Smith & Nephew, Inc. Endoscopy Division
Devices TWINFIX Ultra PLLA/HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black: Part Number: 72202602 Biodegradable suture anchor 50324714 50324959 50325405 50336718 50336766 50337107 50337110 50339396 50339650 50339654 50339835 50340055 50341065 50341288 50341608 50341852 50341974 50343277 50344392 50345531 50346096 50349836 50350192 50351792 50355983 50356629 50357082 50358377 50358556 50359999 50360659 50361740 50362632 50363174 50363872 50366312 50367556 50368583 50369516 50370078 50370505 50371296 50371908 50372043 50372901 50373581 50376024 50376595 50377415 50378045 50378652 50379636 50379935 50381013 50381052 50382145 50383363 50384738 50384957 50385695 50388023 50388427 50388915 50390006 50390936 50391241 50391607 50392270 50392402 50394175 50394700 50395079 50395329 50395678 50396196 50397457 50399965 50400926 50401256 50402972 50403490 50404762 50405432 50405695 50406373 50406776 50407574 50410247 50410909 50411608 50413138 50413770 50414757 50415220 50415662 50416307 50416797 50417199 50417996 50420510 50421494 50421722 50429267 50429347 50429634 50429635 50430369 50433008 50433009 50433120 50433338 50438321 50438322 50438923 50438981 50438982 50440714 50441083 50444410 50446345 50446447 50446997 50448199 50449437 50449827 50450459 50450942 50451511 50451937 50456336 50457052 50457924 50458755 50459278 50459634 50459731 50462225 50467497 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Smith & Nephew, Inc. Endoscopy Division
Devices TWINFIX ULTRA PLLA/HA 5.5 mm Suture Anchor with 3 ULTRABRAID Suture: Part Number: 72202603 Biodegradable suture anchor 50324716 50324717 50326836 50336720 50336769 50337108 50337111 50339644 50339652 50339655 50339836 50340060 50341066 50341289 50341609 50341853 50342712 50344393 50345532 50349940 50375176 50377968 50378734 50380398 50382028 50385516 50386564 50387848 50391713 50392430 50395097 50395980 50396847 50399973 50400923 50402846 50405227 50406208 50406714 50408995 50410652 50411391 50412536 50415225 50415871 50416543 50417398 50428649 50429274 50429621 50429622 50429871 50436765 50436775 50437663 50440391 50443629 50446032 50446451 50446454 50446455 50447009 50447010 50453524 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Smith & Nephew, Inc. Endoscopy Division
Devices TWINFIX" Ultra PLLA/HA 6.5 mm with 2 ULTRABRAID" Suture, White / Black: Part Number: 72202608 Biodegradable suture anchor 50325164 50326837 50336721 50336771 50339645 50339841 50341067 50341975 50344394 50349837 50350415 50351794 50359331 50363876 50368160 50370201 50372046 50375166 50377788 50378916 50380676 50381053 50388605 50392271 50392403 50395799 50403938 50411076 50417379 50422358 50433010 50433121 50438323 50448200 50460082 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Smith & Nephew, Inc. Endoscopy Division
Devices TWINFIX Ultra PLLA/HA 6.5 mm with 3 ULTRABRAID Suture; Part Number: 72202610 Biodegradable suture anchor 50325166 50325167 50327043 50336737 50336772 50339647 50339842 50341976 50385698 50397465 50412290 50417528 50426452 50427818 50429624 50429874 50431563 50453525 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Smith & Nephew, Inc. Endoscopy Division
Devices RAPTORMITE" 3.7 mm PLLA with two ULTRABRAID" Sutures Size 0 and Needles; Part Number: 72201805 Biodegradable suture anchor 50268918 50273148 50273920 50275809 50275812 50282175 50291658 50293289 50296525 50296650 50298707 50305798 50305840 50312502 50312528 50314834 50340632 50343203 50349591 50351817 50358580 50371915 50376235 50387881 50390367 50394081 50396639 50396640 50396641 50399818 50403721 50405089 50412292 50415521 50416545 50418333 50445533 50447145 50454703 50456549 50460175 50460177 50461710 50469565 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Smith & Nephew, Inc. Endoscopy Division
Devices TWINFIX" Ultra 4.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID") with Needles; Part Number: 72202612 Biodegradable suture anchor 50373723 50389654 50389655 50397577 50397596 50397599 50397605 50417226 50431744 50431853 50433695 50437528 50440608 50441690 50447116 50447118 50447119 50448227 50454009 50454867 50461412 50467503 50469159 50470653 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Smith & Nephew, Inc. Endoscopy Division
Devices TWINFIX Ultra 5.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles; Part Number: 72202616 Biodegradable suture anchor 50373722 50397580 50397597 50397602 50397606 50414780 50418109 50431745 50431893 50432157 50438518 50438520 50447115 50447117 50447120 50448228 50449526 50449671 50450004 50454012 50454109 50456362 50459638 50460185 50462233 50468656 50469160 50469533 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Smith & Nephew, Inc. Endoscopy Division
Devices TWINFIX Ultra 6.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles; Part Number: 72202620 Biodegradable suture anchor 50373721 50375642 50397595 50397598 50397604 50397607 50449548 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Smith & Nephew, Inc. Endoscopy Division
Devices 3M Scotchcast, Wet or Dry Cast Padding, Catalog Numbers WDP2, WDP3, WDP4, and WDP6. Intended for use in constructing casts for either wet or dry immobilization. Catalog # - Lot # WDP2 - 792920, 793090, 793640 & 796078. WDP3 - 792921, 793098, 793638, 796077 & 798487. WDP4 - 792922, 793116, 793637, 796079 & 798488. WDP6 792923, 793636, 798489, 799235 & 799236 Class II 3M is conducting a voluntary product recall of selected lots of 3M" Scotchcast" Wet or Dry Cast Padding. Upon investigation of a health care provider feedback, and confirmed with internal testing, it was found that the cast padding material does not consistently repel water. Lack of repellency may result in prolonged cast dry times after exposure to wet conditions. There have been no reports of patient injury associated with this material to date. 3M Company - Health Care Business
Devices AEQUALIS Reversed II or AEQUALIS Fracture Impactor. These products are contained within the Aequalis reversed II Instrument set tray no.YKAD83 and the Aequalis reversed fracture instrument set tray no.YKAD95. The items affected are MWD21, MWD023, MWD024 and MWD025. The impactor is an instrument used during shoulder arthroplasty; it is not implanted. The impactor is used to set the glenoid sphere, poly insert, spacer, and hemi adapter into place during surgery. The impactor is a two piece instrument which consists of a tip and a handle. The tip is made of plastic and metal that is pressed together for assembly. all lots Class II Following the identification of the disassociation of an impactor tip during surgery, Tornier is initiating a voluntary recall of all lots of Aequalis Reversed II and Reversed Fracture impactors. Upon review of the event, Tornier determined that a redesign of the instrument was warranted. These products are contained within the Aequalis Revered II instrument set tray no YKAD83 and the Aequalis Revered Fracture instrument set tray no YKAD95. Tornier, Inc
Devices Vygon 14 Microbore Extension Set with Bionector, CMS-814-1. The CMS-814-1 is a 14 inch extension set used to administer IV fluids. 1203117, 1206030, 1212111, 1304133, 130516 Class II Microbore tubing disconnecting from male luers on the extension sets. Churchill Medical Systems, Inc.
Devices Central Dressing Change Kit; AMS-8464CP- 6. Vygon Central Dressing Change Kit contains: 1 Pair Nitrile Gloves W/Wallet, Powderfree 1 Face Mask 1 Polylined Drape, 13" X 18" 1 ChloraPrep***, 3ml Applicator W/Insert 1 Pkg. Alcohol Swabsticks (3/Pkg.) 1 14" Extension Set W/Bionector*** 2 Dressing Sponges, 2" X 2" 1 Foam Strip, 8/5cm X 1cm 1 3M*** Tegaderm *** IV Dressing W/CHG, 2 1/2" X 4 1/2" *** Vygon MFG Dover, NH 03820***" Lot Numbers: 1303022, 1304065 Class II Microbore tubing disconnecting from male luers on the extension sets. Churchill Medical Systems, Inc.
Food Coffee Cake: queso/guava (cheese/guava) no codes Class II Undeclared allergens: Yellow #5 and Yellow #6 Jean's Cake
Food Coffee Cake: queso crema (creme cheese) no codes Class II Undeclared allergens: Yellow #5 and Yellow #6 Jean's Cake
Food Coffee Cake: queso/fresa (cheese/strawberry) no codes Class II Undeclared allergens: Yellow #5 and Yellow #6 Jean's Cake
Food Coffee Cake: queso/manzana (cheese/apple) no codes Class II Undeclared allergens: Yellow #5 and Yellow #6 Jean's Cake
Food Professor Zim Zam's Extraordinary Sweets; Dark Chocolate with Sea Salt; All Natural, 55% Cocoa; Net Wt. 0.35 oz (9.9g) Go Picnic: Distributed by Go Picnic Brands, Chicago, IL 60613; Made in USA UPC: 8 90026 00218 4 All codes. Class I Two consumer complaints of allergic reactions for Zim Zam products packed in a picnic type lunch that declares it is vegan. G. Debbas Chocolatier does not claim that their product facility is vegan, as they do make product that contain milk. G. Debbas Chocolatier, Inc.
Food Professor Zim Zam's Extraordinary Sweets; Dark Chocolate with Rice Crisps; All Natural, 55% Cocoa; Net Wt. 0.35 oz (9.9g) Go Picnic: Distributed by Go Picnic Brands, Chicago, IL 60613; Made in USA UPC: 8 90026 00220 7 All codes. Class I Two consumer complaints of allergic reactions for Zim Zam products packed in a picnic type lunch that declares it is vegan. G. Debbas Chocolatier does not claim that their product facility is vegan, as they do make product that contain milk. G. Debbas Chocolatier, Inc.
Food Professor Zim Zam's Extraordinary Sweets; Dark Chocolate with Orange; All Natural, 55% Cocoa; Net Wt. 0.35 oz (9.9g) Go Picnic: Distributed by Go Picnic Brands, Chicago, IL 60613; Made in USA UPC: 8 90026 00219 1 All codes. Class I Two consumer complaints of allergic reactions for Zim Zam products packed in a picnic type lunch that declares it is vegan. G. Debbas Chocolatier does not claim that their product facility is vegan, as they do make product that contain milk. G. Debbas Chocolatier, Inc.
Devices Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Screw System is a non-cervical spinal fixation device. 1)Screw Tower - REF 14-501660 2) Rod Reduce - REF 14-501661 3) Counter Torque - REF 14-501662 14-501660 Screw Tower Lots IT0024 IT0025 IT0026 IT0027 IT0028 IT0029 14-501661 Rod Reducer Lots IT0015 IT0022 IT0023 14-501662 Counter Torque Lots IT0020 IT0021 Class II Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System. Ebi, Llc
Drugs Acetylcysteine 20% Solution, Preservative Free, 4 mL Sterile Single Dose Vial, Not for Injection, Sterile Solution For Office Use Only, JCB Laboratories, Wichita, KS. Lot # 130627@5, Exp 08/26/2013 Class II Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured. JCB Labs LLC
Drugs Sodium Thiosulfate 25%, 250 mg/mL (12.5 g/50mL), PF Sterile Solution for Injection, 50 mL Single Dose Vial, For Office Use Only, JCB Laboratories, Wichita, KS. Lot #: 130701@9, Exp 12/28/2013; 130709@6, Exp 01/05/2014; 130717@2, Exp 01/13/2014 Class II Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured. JCB Labs LLC
Drugs Sodium Citrate 4% containing Gentamicin 320 mcg/mL, Solution for Injection, 30 mL Multi Dose Vial, Sterile Solution For Office Use Only, JCB Laboratories, Wichita, KS. Lot # 130620@2, Exp 12/17/2013 Class II Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured. JCB Labs LLC
Drugs Sodium Citrate 4% Solution for Injection, 30 mL Multi Dose Vial, Sterile Solution for Office Use Only, JCB Laboratories, Wichita, KS. Lot # 130710@4, Exp. 01/06/2014 Class II Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured. JCB Labs LLC
Drugs Epinephrine 1:1,000 (1mg/mL) Sterile Solution for injection, Preservative Free/Sulfite Free, 1-mL Single-Use Syringe, Sterile Solution For Office Use Only, JCB Laboratories, Wichita, KS. Lot # 130806@2, Expiry 09/20/2013. Class II Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured. JCB Labs LLC
Drugs Dextrose 50% Preservative Free SDV Injection Solution, 50 mL Single dose vial, IV Administration, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126 Lot 06072013@49, Exp 9/5/13 Class II Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS results were reported to customers as passing. Hence the sterility of these products cannot be assured. Leiter's Pharmacy
Drugs Hyaluron (hyaluronidase) 150 units/mL Preserved Solution, 1 mL, Multi Dose Vial, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126 Lot #: 06122013@9; Exp 9/10/13 Class II Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS results were reported to customers as passing. Hence the sterility of these products cannot be assured. Leiter's Pharmacy
Drugs Bevacizumab (Avastin) 2.5mg/0.1mL PF Inj., 0.1 mL syringe, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126 Lot #: 08052013@1, 08052013@4, Exp 11/03/2013 Class II Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS/failed results were reported to customers as passing. Hence the sterility of the products cannot be assured. Leiter's Pharmacy
Drugs Lidocaine/Phenylephrine PF 1%/1.5% Injectible vials, 1 mL Single Use Vial, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126 Lot # : 07302013@6 Exp 10/28/13 Class II Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS/failed results were reported to customers as passing. Hence the sterility of these products cannot be assured. Leiter's Pharmacy
Devices GE Healthcare, Advantage Workstation, READY View Application. Image analysis software. Mfg Lot or Serial # 00000235940GE4 00000260698GE6 00000260686GE1 00000235943GE8 00000253548GE2 00000260699GE4 000000010006GS 00000L3AB501ED 00000253550GE8 00000253551GE6 00000260681GE2 00000260682GE0 00000260683GE8 00000260684GE6 00000260685GE3 00000260687GE9 00000260688GE7 00000260689GE5 00000260690GE3 00000260691GE1 00000260692GE9 00000260693GE7 00000260694GE5 00000260695GE2 00000260696GE0 00000260697GE8 00000253549GE0 00000235942GE0 0000AQ11258001 000000010005GS 0000CZC1337NYP 00000Q11076015 0000AV11249006 0000AQ11265005 0000AQ11265003 000D1L3AAF7CD2 00000L3AB68D60 00000L3A2BABE7 00000L3AAFB343 00000235941GE2 000000010022GS 00000222344GE4 00000253546GE6 000000010013GS 00000L6B045EFC  ...
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Class II GE Healthcare has become aware that when analyzing fMRI images using the READY View application software, incorrect fMRI activation maps may be computed and displayed. GE Healthcare, LLC
Food Fresh Basil (Sweet Hawaiian and Thai) New Dream Team Inc. HI no codes Class III State of HI issued Cease and Desist Order to grower of basil for positive sample results for pesticides not allowed on basil. New Dream Team
Drugs IBU (TM) IBUPROFEN Tablets, USP, 800 mg, 500 -count bottle,(NDC 55111-684-05) Rx only, Distributed by Dr. Reddy's Laboratories, Inc., Bridgewater, NJ 08807 USA. Lot # L300192; Exp. 05/2017 Class II Labeling: Incorrect or missing lot and/or exp date- This product is being recalled due to an incorrect expiration date of 05/2017. The correct expiration date is 10/2016. Dr. Reddy's Laboratories, Inc.
Food Frozen, 4/3 lb unlabeled bags contained in a master carton box labeled in part: "Portico Brand 4/3 lb 170585 Breaded Scallops***Net Wt 12 lb (5.44 kg)***Ingredients:Scallops, Bleached Wheat Flour, Water, Modified Corn Starch, Sugar, Yellow Corn Flour, Salt, Textured Soy Flour, Yeast, Dried Whole Eggs, Sodium Tripolyphosphate, Partially Hydrogenized Soybean Oil, Xanthan Gum, Sodium Hexametaphosphate. Contains: Wheat, Soy, Egg." 322461L (01283) Class I Incorrect Ingredient Labeling Tampa Maid Foods, Inc.
Devices GE Healthcare, Seno Advantage, 5183685, 5183685-2, 5183685-3, 5183685-4, 5183685-5, 5183685-6, 5183685-7, 5183685-8, 5183685-9, 5342425, 5342425-2, 5342425-3, 5342425-4, 5342425-5. Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. When interpreted by a trained physician, mammographic images displayed on the high-resolution monitors may be used as an element for diagnosis. Furthermore filmed images from all modalities may also be used as an element for diagnosis. Seno Advantage Workstations with RIS CCOW integration: Patient mismatch while receiving images - FMI 12187 Serial # 00000179275GE3 00000136608GE7 00000136609GE5 00000123803GE9 00000206492GE1 00000179274GE6 00000179273GE8 00000179272GE0 00000177331GE6 00000128528GE7 00000132314GE6 00000106422GE9 00000188371GE9 00000179281GE1 00000179282GE9 00000106426GE0 00000106427GE8 00000250274GE8 00000142837GE4 00000142836GE6 000000010001GS 00000114907GE9 00000158810GE2 00000084251GE8 00000112122GE7 00000123807GE0 000000310001GS 000000010008GS 000000010007GS 00000106420GE3 00000114906GE1 00000250277GE1 00000165231GE2 00000136610GE3 00000114088GE8 00000114089GE6 00000112926GE1 00000206490GE5 00000154938GE5 00000190211HP3 00000174027GE3 00000174026GE5 00000190278HP2 000000010004GS 00000164500GE1 00000158809GE4 00000158410GE1 00000165228GE8 00000165229GE6 00000123804GE7 00000166277GE4 00000114091GE2 00000106425GE2 00000106424GE5 00000179280GE3 00000200442GE2 00000250278GE9 00000126082GE7 00000206491GE3 00000164502GE7 00000164503GE5 000000510001GS 00000253622GE5 00000128529GE5 00000126080GE1 00000195402GE3 00000195403GE1 00000218675GE7 00000218674GE0 00000220618GE3 000000010011GS 00000190212HP1 00000220619GE1 000003510001GS 00000117141GE2 00000142832GE5 00000200440GE6 000003310002GS 00000022062GE9 000003310001GS 00000250290GE4 00000295750GE4 00000295751GE2 00000250276GE3 00000295753GE8 00000295752GE0 00000158812GE8 00000166279GE0 000000610001GS 00000075247GE7 00000106423GE7 00000080399GE9 000000610005GS 00000170113GE2 00000L02687311 000000ANT26269 000000G8087001 000000ANT23044 000000ANT25613 000000C7177002 00000193277GE1 00000149802GE1 00000149801GE3 00000165230GE4 000003510003GS 000000310002GS 000000310003GS 000004410002GS 000000610002GS 00000126078GE5 00000126079GE3 000000210002GS 00000164501GE9 00000117137GE0 00000119932GE2 00000142838GE2 000000Q7274004 000000M9335002 000000Q7274002 000000010005GS 000000N7302006 000000C7177009 000000C7177015 00000050606AW3 000000K7291002 000000Q7274005 000000C7177008 000000C7177010 00000Q11031001 00000Q11031003 000000610006GS 0000AG12200001 000000G9278001 00000L11224002 00000H11230001 0000ZA11210001 00000F11278001 0000AT11264001 000000S8340001 000000010001GS 00000J10019001 00000ZA9233001 00000N10193003 00000D10166001 000000B7339013 00000H11230002 0000AL11360001 00000H12052001 00000J11314001 000000S8135001 000000010003GS 000000T9021003 000000C7177020 000000010002GS 000000U7164006 00000050607AW1 000000Q7274001 00000054750AW5 00000054849AW5 000000010006GS 000000W9301001 000000T7250001 000000T7323003 000000T7323002 000000P8081001 000000S8135002 000000G8021002 00000050605AW5 00000050604AW8 00000G10264001 00000N10071001 00000P10046001 000000C7177019 0000AB11012002 00000M11006003 0000AB11012001 00000R11320001 000000R9058001 0000AT11264003 Class II GE Healthcare has recently become aware that patient mismatch without a warning message could occur on Seno Advantage (SA) workstations under certain circumstances. This issue may impact patient safety. GE Healthcare, LLC
Food Meyer Lemon Braising Base, 1lb. 8.5 oz, 12 jars/case Lot #: 12213-2PF1, 12213-2PF2, 12213-2PF3 Class I Premier Foods is recalling Williams-Sonoma flavored sauces due to undeclared milk, soy (hydrolyzed soy protein), and wheat allergens. Premier Foods, LLC
Food 40-Clove Garlic Chicken Braising Base, 24.5oz, 12 jars/case Lot #: 12713-10PF1, 12713-10PF2 Class I Premier Foods is recalling Williams-Sonoma flavored sauces due to undeclared milk and wheat allergens. Premier Foods, LLC
Food Tagine Sauce, 16 fl. oz., 12 jars/case Lot #: 08413-14PF1, 08413-14PF2 Class I Premier Foods is recalling Williams-Sonoma flavored sauces due to undeclared milk and wheat allergens. Premier Foods, LLC
Food Artichoke Pecorino Sauce, 16 fl. oz., 12 jars/case Lot#: 01813-16PF1, 01813-16PF2, 01813-16PF3, 01813-16PF4 Class II Premier Foods is recalling Williams-Sonoma flavored sauces due to undeclared soy allergens (hydrolyzed soy protein). Premier Foods, LLC
Devices C2244.3808, CONELOG Titanium Base CC Ø3.8GH0.8 inkl HS Product Usage: Endosseous dental implant abutment CONELOG Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CONELOG implants to support prostheses in the maxillary and/or mandibular arch. 43746 Class II Product not cleared for sale/use in the United States. Camlog Usa
Devices C2244.3820;, CONELOG Titanium Base CC Ø3.8GH2.0 inkl HS Product Usage: Endosseous dental implant abutment CONELOG Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CONELOG implants to support prostheses in the maxillary and/or mandibular arch. 39437 Class II Product not cleared for sale/use in the United States. Camlog Usa
Devices C2244.4308 CONELOG Titanium Base CC Ø4.3GH2 0.8 inkl HS Product Usage: Endosseous dental implant abutment CONELOG Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CONELOG implants to support prostheses in the maxillary and/or mandibular arch. 4460 and 44163 Class II Product not cleared for sale/use in the United States. Camlog Usa
Devices C2244.5008 CONELOG Titanbasis CAD/CAM Conelog Titanium Base CAD/CAM Rx only Ø5.0GH 0.8 inkl HS Product Usage: Endosseous dental implant abutment CONELOG Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CONELOG implants to support prostheses in the maxillary and/or mandibular arch. lot 43377 Class II Product not cleared for sale/use in the United States. Camlog Usa
Devices GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B650 is indicated for monitoring and recording of, and to generate alarms for, hemodynamic (including EGG, ST segment, arrhythmia detection, ECU diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature and mixed venous oxygen saturation), impedance respiration, airway gases (C02, 02, N20 and anesthetic agents), spirometry, gas exchange, and neurophysiological (including electroencephalography, Entropy, Bispectral Index (HI1S) and neuromuscular transmission) status. The CARESCAPE Monitor B650 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network. The CARESCAPE Monitor B650 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The CARESCAPE Monitor B650 is not intended for use during MRI. Parent SN SEW10233202HA SEW10233203HA SEW10233204HA SEW10233206HA SEW10233209HA SEW10233210HA SEW10243447HA SEW10243449HA SEW10243450HA SEW10243458HA SEW10243476HA SEW10243477HA SEW10243478HA SEW10243479HA SEW10243481HA SEW10243482HA SEW10243484HA SEW10243486HA SEW10243487HA SEW10243489HA SEW10243490HA SEW10243491HA SEW10243492HA SEW10243496HA SEW10243498HA SEW10243499HA SEW10243500HA SEW10243503HA SEW10243504HA SEW10354687HA SEW10354688HA SEW10354694HA SEW10354695HA SEW10354696HA SEW10354697HA SEW10354701HA SEW10354704HA SEW10354706HA SEW10354707HA SEW10354708HA SEW10354709HA SEW10354712HA SEW10354713HA SEW10354717HA SEW10354722HA SEW10354724HA SEW10354728HA SEW10354730HA  ...
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Class II GE Healthcare has recently become aware of a number of potential issues associated with the CARESCAPE Monitor B650. No injuries or illnesses have been reported. GE Healthcare, LLC
Devices Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller Road, Cincinnati, OH 45241 Hyper-Hypothermia device used to lower or to raise a patients temperature and/or maintain a desired patient temperature through conductive heat transfer. Part number: 86107/06107/6107 (115V), Serial #s: 112-3-02021, 112-3-02102 through 124-3-02783, 074-3-00388, 081-3-00489, 081-3-00493, 082-3-00511, 091-3-00935, 094-3-01261, 094-3-01265, 094-3-01272, 094-3-01304, 094-3-01308, 101-3-01384, 093-3-01045, 093-3-01046, 093-3-01069, 084-3-00775, 073-3-00315, 091-3-00918, 091-3-00919, 073-3-00279, 094-3-01262, 071-3-00183, 092-3-00983, 094-3-01255, 064-3-00114, 072-3-00219, 072-3-00222, 072-3-00230, 072-3-00258, 081-3-00499, 081-3-00500, 064-3-00116, 064-3-00117, 092-3-01021, 073-3-00305, 073-3-00314, 082-3-22572, 082-3-22573, 101-3-01380, 073-3-00317, 074-3-00341,  ...
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Class II During a label review it was discovered that both the Blanketrol III Operations (57201-N) & Operations & Technical (56201-Q) manuals had verbiage added back into the manual during ECN M111-4260 (released 12/29/2011) which was previously removed for clarification of the intended use and subsequent 501(K) approval. Cincinnati Sub-Zero Products Inc
Devices GE Healthcare, CARESCAPE Monitor B850. Intended for use in multiple areas within a professional healthcare facility. Serial Number 6617967 6617968 6617969 6619157 6619158 6619159 6619160 6626633 6626634 6637287 6660104 6693980 6720596 6720597 6720598 6720599 6739266 CZC0044VY8 CZC0044VYL CZC0044VYY CZC0044VZ1 CZC0044VZ5 CZC0044VZ6 CZC0044VZ7 CZC0044VZ8 CZC0044VZB CZC0070P7B CZC0070P7G CZC0133FMM CZC0133FMS CZC0133FN7 CZC0182JL2 CZC0182JL8 CZC02211YN CZC0249CL3 CZC0249CL5 CZC0249CL7 CZC0249CLF CZC0249CLK CZC03336CT CZC03336D1 CZC03336D6 CZC0334KJ5 CZC0334KJ6 CZC0366ZR0 CZC0468W4H CZC1027W82 CZC1027W85  ...
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Class II GE Healthcare has recently become aware of an issue associated with the CARESCAPE Monitor B850 when used with the iCentral network. The iCentral must have the alarm management software license (L-NETM-00) and the alarm limit change option enabled to experience this issue. When changing the HR, SpO2 or Invasive pressure alarm limits from the iCentral over the network, the alarm priority on the CARESCAPETM Monitor B850 inadvertently changes from Escalating to the startup level of the escalation (e.g., low for HR Alarms). Alarms for other parameters are not affected. GE Healthcare, LLC
Drugs Vicks NyQuil Cold and Flu Nighttime Relief, Liquid Twin Pack, (Acetaminophen 650mg, Dextromethorphan HBr 30mg, Doxylamine succinate 12.5mg), 12 fl oz (354 ml) bottles, Distributed by Procter & Gamble, Cincinnati, OH 45202, NDC 37000-807-12 Lot #s 31614334R1, 31814334R1, Exp 5/15; Twin packs were further packaged in display coded with following 4 Lot #s (display received by WalMart only): 3051A152HK, Exp 1/15, 3051A152HL, Exp. 1/15, 3051A152HM, Exp 1/15, 30746493F5, Exp 2/15 Class II Incorrect/ Undeclared Excipients: NyQuil Liquid Original bottles were inadvertently overwrapped with NyQuil Liquid Cherry information as a result the outer wrap does not correctly identify color additives, particularly FD&C Yellow No. 6 and FD&C Yellow 10. Procter & Gamble Co
Devices GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System. The angiography X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image guided surgical procedures. The OR table is suitable for interventional and surgical procedures. Mfg Lot or Serial # 00000611882BU2 00000612803BU7 00000613979BU4 00000620447BU3 Class II GE Healthcare has recently become aware of a potential safety issue with respect to Discovery IGS 730 Imaging Systems. A patient data management error may prevent the Discovery IGS 730 Imaging System from booting on start-up or re-booting during procedure. The boot issue may occur when a large amount of patient data remains in the browser and is not deleted. The inability to boot the system may lead to a complete loss of real-time interventional imaging functionality. No injuries have been reported due to this issue. GE Healthcare, LLC
Drugs Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5 mg/650 mg Tablets, 500 Count Bottle, Manufactured by: Watson Laboratories, Inc, Cocona, CA 92880, NDC 0591-2611-05. Lot 706224A and 706225A, Exp. 04/15. Class III Defective Container: Defective bottles may not have tamper evident seals properly seated, and therefore it may be difficult to determine if the product had been opened or tampered with. Watson Laboratories Inc
Drugs Testosterone Cyp 200 mg/mL, W/Pres. (Benzyl ETOH), 3 mL, Medaus pharmacy 1-800-526-9183 LOT # 130508-1, BUD: 11/16/2013 Class II Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured. Medaus, Inc.
Drugs Lipo-Injection w/ Lidocaine (PF), Ascorbic Acid 50 mg; B1-50 mg; B2-5-PO4-5 mg; B3-50 mg; B5-5 mg; B6-5 mg; Cyano B12-100 mcg; Methionine 12.5 mg; Inositol-25 mg; Choline-25 mg; Lidocaine 10 mg/mL, 30 mL, Medaus Pharmacy 1-800-526-9183 Lot #: 130510-26, Exp 11/16/2013; 130610-24, Exp 12/7/2013; and 130709-68, Exp 1/5/2014 Class II Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured. Medaus, Inc.
Drugs Taurine 50 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183 LOT # 130618-64, BUD: 12/15/2013 Class II Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured. Medaus, Inc.
Drugs L-Glutathione 200 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183 LOT # 130617-10, Exp 12/14/2013 Class II Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured. Medaus, Inc.
Drugs Pyridoxine HCL 100 mg/mL NS (PF), 30 mL, Medaus Pharmacy 1-800-526-9183 LOT # 130531-31, Exp 11/27/2013 Class II Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured. Medaus, Inc.
Drugs Magnesium Chl 200 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183 LOT # 130307-60, Exp 9/3/2013 Class II Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured. Medaus, Inc.
Drugs NA Ascorbate 500 mg/mL, PF, 100 mL, Medaus Pharmacy 1-800-526-9183 LOT # 130702-1, Exp 12/29/2013 Class II Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured. Medaus, Inc.
Drugs NA Ascorbate 500 mg/mL, non corn PF, 100ML, Medaus Pharmacy, 1-800-526-9183 LOT # 130613-8, Exp 12/10/2013 Class II Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured. Medaus, Inc.
Devices Zeppessis' reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and Neptune 2 Waste Management Systems: The Neptune Waste management system is intended to be used in the Operating Room, Surgical Centers and Doctor's Offices to collect and dispose of surgical fluid waste as well as collect smoke generated from electrocautory or laser devices. ***The single-port manifold for the Stryker Neptune 1 (part # 700-015-000) can be used with the: Neptune 1 Gold Rover or the Neptune Bronze Rover as an accessory to Class 2 Air-handling apparatus for a surgical operating room (Sec. 878.5070); or with the Neptune 1 Silver Rover as an accessory to Class 2 Powered suction pump. ***four-port manifold for the Stryker Neptune 1 (part # 700-020-000) can be used with the: Neptune 1 Gold Rover or the Neptune Bronze Rover as an accessory to Class 2 Air-handling apparatus for a surgical operating room (Sec. 878.5070); or with the Neptune 1 Silver Rover as an accessory to Class 2 Powered suction pump. ***single-port manifold for the Stryker Neptune 2 (part # 702-025-000) can be used with the Neptune 2 Rover Ultra as an accessory to Class 2 Powered suction pump. ***four-port manifold for the Stryker Neptune 2 (part # 702-020-000) can be used with the Neptune 2 Rover Ultra as an accessory to Class 2 Powered suction pump. -Single-port manifold for the Stryker Neptune 1 (part # 700-015-000); -Four-port manifold for the Stryker Neptune 1 (part # 700-020-000); -Single-port manifold for the Stryker Neptune 2 (part # 702-025-000); -Four-port manifold for the Stryker Neptune 2 (part # 702-020-000). Class II Zeppessis' reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and Neptune 2 Waste Management Systems are recalled due to lacking 510K and and without a validated cleaning protocol for reprocessing the used manifolds. Zeppessis Reprocessing, LLC
Devices King LT-D Oropharyngeal Airways Class 1, 510(k) exempt The King LT-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents. Part Number KLTD2125 Lot Number I10RG Class III King Systems is initiating a voluntary recall of an affected lot of its KLTD products shipped on April 30, 2013. King Systems has received a report that size 5 KLTD airways were packaged in pouches indicating a size of 2.5 and shipped to your facility. The correct size of the KLTD airway is clearly marked on the actual airway product and the physical size difference between 2.5 and 5 is distinct and obvious. King Systems has received no reports of serious injuries or deaths resulting from this issue. King Systems Corp.
Devices Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INSHITHRZN The kits allow for access to the subarachnoid space or the lateral ventricles of the brain. The kits are intended to be used with an external drainage and monitoring system in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF, and to monitor ICP. INSHITH Lots: W1205183,,W1207036,,W1209165,,W1209166,,W1209168,,W1210156,,W1210157,,W1210158,,W1210159,,W1210160,,W1211021,,W1211030,,W1211135,,W1211136,,W1211137,,W1212170 INSHITHND Lots: W1210230 INSHITHRZN Lots: W1209156,,W1211182,,W1212090,,W1212125,,W1212178,,W1301258,,W1302005,,W1302031,,W1303148 Class II Integra is recalling certain lots of Cranial Access Kit due to a possibility that the seal integrity of the sterile package may become compromised during shipping. Integra LifeSciences Corp. d.b.a. Integra Pain Management
Food Olde Cape Cod Chipotle Ranch dressing, 16 oz. Item Number: 90997-11630 Best By date of Nov. 30, 2014 Class I Product may be labeled with an incorrect back panel label that does not declare the allergens milk and egg. Cains Foods L.P.
Drugs Hydroxocobalamin MDV 5 mg/mL (5,000 mcg/mL) Inj., 10 mL vial X 3, Eastern States Compounding Pharmacy, Littleton, NH 03561 Lot #: 08022013@34, Exp11/3/2013 Class II Lack of Assurance of Sterility: The pharmacy is recalling one lot of Hydroxocobalamin MDV 5mg/mL due to failed sterility results by a third party contract testing lab. Hence the sterility of the product cannot be assured. Northern New England Compounding Pharmacy LLC
Devices Osseotite 2 Certain Prevail 5mm(D)X 4.1mm (P) X X 11.5mm (L) Dental Implant Product Usage: Surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures. XIIOS5411 Class II One of the dental implants do not have the internal hex feature. One of the dental implants do not have the internal thread feature. Biomet 3i, LLC
Devices Osseotite Parallel Walled Certain 4mm(D)X 15mm (L) Dental Implant Product Usage: Surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures. IOSS415 Class II One of the dental implants do not have the internal hex feature. One of the dental implants do not have the internal thread feature. Biomet 3i, LLC
Devices Device Name: Terino Square Chin-Style II-Medium; Catalog Number: TSCII-M. To augment or reconstruct underdeveloped or traumatized mandibular region. Catalog Number: TSCII-M Lot Numbers: 848488 and 850156 Class II Implantech initiated a voluntary recall of certain lots of Terino Square Chin-Style II-Medicum (Lot # 848488 and 850156), after determining that the devices from the lot numbers do not conform to the dimensional requirements for the TSCII-M. Implantech Associates Inc
Drugs Bevacizumab 1.25 mg/0.05 mL PF, Avella Specialty Pharmacy, Phoenix, AZ, 85085, 877-782-7684 12-20130508@179, Exp 11/3/2013 Class II Lack of Assurance of Sterility: Avella Specialty Pharmacy is recalling bevacizumab and vancomycin due to concerns of sterility assurance with the specialty pharmacy's independent testing laboratory. Avella of Deer Valley, Inc.
Drugs Vancomycin PF (BSS) 1%, 1 mL, Avella Specialty Pharmacy, Phoenix, AZ 85085, 877-782-7684 12-20130508@181, Exp 10/4/2013 Class II Lack of Assurance of Sterility: Avella Specialty Pharmacy is recalling bevacizumab and vancomycin due to concerns of sterility assurance with the specialty pharmacy's independent testing laboratory. Avella of Deer Valley, Inc.
Food Pills bury Cinnamon Rolls with Icing, CINNA BON, USPC 1800000501, 1800052230, 12.4 oz and 2-pack USPC 1800045675,2- 12.4 oz (351 G) CANS, NET WT 24.8 OZ (1 LB 8.8 OZ 703 G. Better if Used Date on Package: 30OCT2013, 31OCT2013, 18OCT2013, 26OCT2013 and 31OCT2013. Class II General Mills is recalling a limited quantity of refrigerated Pills bury Cinnamon Rolls with Icing. The dough may contain fragments from a broken piece of plastic on the production line. General Mills, Inc
Devices POWERWAND Safety Introducer with Extended Dwell Catheter; Catalog no. 92006. Used to gain access to the vascular system to sample blood and administer fluids intravenously. Lot no. I666473 Class II Access Scientific is recalling the POWERWAND Saftey Introducer with Extended Dwell Catheter because it is mislabeled. Access Scientific Inc
Food Bean & Cheese Burrito Filling, 10 lb bags Labeled in part "13210 B 1 77220 13:38 KEEP FROZEN BEAN & CHEESE BURRITO FILLING***INGREDIENTS: COOKED PINTO BEANS, WATER, CHEDDAR CHEESE***SOYBEAN OIL***STARCH-MODIFIED, ONIONS, CHEESE SAUCE BASE***CONTAINS LESS THAN 2% OF CHILI PEPPER, SALT, CHICKEN BASE***SODIUM PHOSPHATES, SPICE, CARAMEL COLOR DEHYDRATED, GARLIC, ANNATTTO EXTRACT." CONTAINS: Soy, Milk, Wheat JTM Food Group 200 Sales Dr. Harrison, OH 45030 Phone 800.626.2308. Lot #13210 B 1 77220 13:38 Class I Undeclared eggs in the product. The firm was notified by their customer that the product contains pasta. The pasta contains eggs which is not declared on the label. JTM Provisions Co Inc
Devices NX3 Try-In Gel. The product is used as a tooth shade resin material. Part Number 33660. Syringe Lot Number 4580333. Autobag Lot Number 4584609. Class II Kerr Corporation is voluntarily recalling one lot of NX3 Try-In Gel, because some of the NX3 Try-In Gel syringes in the affected lot contain a different product material. The material in the affected syringe does not match the shade of the cement as it is labeled. Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
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