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U.S. Department of Health and Human Services

Enforcement Report - Week of June 5, 2013

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Red Blood Cells Leukocytes Reduced 01LJ41562 Class II Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed. American National Red Cross (The)
Biologics Platelets Pheresis Leukocytes Reduced 2432047 Class II Blood products, labeled leukoreduced which did not meet the requirements for leukoreduced products, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Platelets Leukocytes Reduced 2432106 (split product) Class II Blood products, which did not meet the specified pH for platelets, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells 6772914; 6772936; 6772968; 6772994; 6777568; 6782640; 6782660; 6787452; 6787455; 6787484; 6787677; 6787684; 6787704; 6787750; 6792487; 6792517; 6792529; 6792541; 6792543; 6792566; 6792572; 6792580; 6792596; 6792616 Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. Community Blood Center of the Ozarks
Biologics Red Blood Cells Leukocytes Reduced 6771844; 6772928; 6772953; 6772954; 6772957; 6772969; 6772984; 6772988; 6772993; 6785513; 6785518; 6785525; 6787661 Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. Community Blood Center of the Ozarks
Biologics Blood and Blood Products for Reprocessing 3772819; 3778044; 6713590; 6713593; 6713595; 6713597; 6714962; 6725151; 6725153; 6725156; 6725168; 6725170; 6725171; 6725190; 6725192; 6725194; 6725197; 6725200; 6725203; 6725204; 6725206; 6725207; 6725208; 6725209; 6725210; 6725211; 6725218; 6725220; 6725222; 6725225; 6725615; 6725768; 6726419; 6730260; 6731455; 6731539; 6731635; 6737411; 6737416; 6737417; 6737418; 6737419; 6737430; 6737432;6737438; 6737442; 6737445; 6737446; 6737449; 6737451; 6737453; 6737454; 6737455; 6737456; 6737460; 737461; 6737465; 6737470; 6737477; 6737478; 6737479; 6737480; 737481; 6737484; 6737484; 6737485; 6737486; 6737499; 6737500; 6737501; 6737503; 6737504; 6737507; 6737508; 6737509; 6737512; 6737516; 6737518; 6737519; 6737520; 6737525; 6737530; 6737531; 6737533; 6737534; 6737535; 6737537; 6737541; 6737542; 6737545; 6737547; 6737550; 6737555; 6737556; 6737558; 6737559; 6737561; 6737563; 6737572; 6737573; 6737575; 6737577; 6737578; 6737581; 6737585; 6737586; 6737591; 6737592; 6737607; 6737609; 6737610; 6737613; 6737615; 6737626; 6737636; 6737641; 6737644; 6737647; 6737649; 6737652; 6737653; 6737657; 6737661; 6737663; 6737670; 6737674; 6737678; 6737680; 6737693; 6737709; 6737713; 6737727; 6737733; 6737734; 6738931; 6738974; 6738981; 6738983; 6739032; 6742616; 6742633; 6744553; 6745834; 6745895; 6746018; 6746021; 6746028; 6746069; 6746070; 6746119; 6746123; 6746475; 6746482; 6746498; 6747375; 6747376; 6747377; 6747378; 6747384; 6750700; 6750702; 6751276; 6751294; 6751305; 6751315; 6751329; 6751331; 6753648; 6753654; 6753671; 6753681; 6755189; 6755196; 6757571; 6757619; 6757626; 6757631; 6757650; 6757683; 6758562; 6758566; 6758567; 6758570; 6758574; 6760288; 6760292; 6760300; 6760310; 6760318; 6760322; 6760332; 6761069; 6761082; 6761086; 6761089; 6761097; 6761120; 6761121; 6761124; 6761133; 6761146; 6761148; 6771148; 6771178;6771179; 6771186; 6771191; 6771205; 6771225; 6771285; 6771303; 6771310; 6771852; 6772750; 6772751; 6772755; 6772756; 6772759; 6772759; 6772762; 6772768; 6772771; 6772774; 6772776; 6772779; 6772782; 6772782; 6772783; 6772784; 6772787; 6772791; 6772792; 6772793; 6772795; 6772800; 6772802; 6772804; 6772805; 6772811; 6772822; 6772828; 6772831; 6772833; 6772836; 6772837; 6772840; 6772842; 6772844; 6772848; 6772850; 6772855; 6772861; 6772868; 6772868; 6772882; 6772884; 6772886; 6772888; 6772890; 6772892; 6772893; 6772894; 6772898; 6772905; 6772907; 6772912; 6772913; 6772914; 6772915; 6772918; 6772920; 6772922; 6772923; 6772924; 6772936; 6772941; 6772942; 6772948; 6772953; 6772954; 6772957; 6772958; 6772964; 6772966; 6772969; 6772984; 6772988; 6772990; 6772992; 6772993; 6772994; 6777568; 6777570; 6777576; 6777579; 6777582;6778033;6778037;6778051;6782905;6782913;6782914 Class III Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. Community Blood Center of the Ozarks
Biologics Cryoprecipitated AHF 6713590; 6721055; 6725204; 6725206;6725207; 6725208; 6725209; 6725210; 6725211; 6725218; 6725220; 6725222; 6725225; 6725768; 6737670; 6737689; 6737732 Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. Community Blood Center of the Ozarks
Biologics Plasma Cryoprecipitate Reduced 6737687; 6737690 Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. Community Blood Center of the Ozarks
Biologics Platelets 6787684; 6787747; 6787750 Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. Community Blood Center of the Ozarks
Biologics Fresh Frozen Plasma 6731455; 6771161; 6772928; 6772931 Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. Community Blood Center of the Ozarks
Biologics Platelets Leukocytes Reduced 4727989; 4727982A; 4727982B. Class II Blood products, which did not meet the acceptable product specifications, were distributed. Northwest Florida Blood Center, Inc.
Biologics Platelets Pheresis Leukocytes Reduced 4072021A; 4072021B. Class II Blood products, which were labeled as leukoreduced, but were not tested to verify the White Blood Cell count, were distributed. Northwest Florida Blood Center, Inc.
Biologics Source Plasma LF240346; LF240044; LF239620; LF239240; LF238990; LF238603; LF238237; LF237823; LF237303; LF237056. Class II Blood products, collected from a donor who was permanently deferred after testing reactive for Hepatitis B surface antigen (HbSAg), were distributed. BioLife Plasma Services L.P.
Biologics Red Blood Cells Leukocytes Reduced 4952908 Class III Blood product, manufactured from Whole Blood units that may have had an extended collection time, was distributed. Northwest Florida Blood Center, Inc.
Biologics Red Blood Cells Leukocytes Reduced Irradiated 4074426 Class III Blood product, which was not manufactured in accordance to acceptable product specifications, was distributed. Northwest Florida Blood Center, Inc.
Biologics Platelets Leukocytes Reduced 8464482- A, 8464482- B Class III Blood products, collected from a donor whose temperature was not documented, were distributed. Atlanta Blood Services
Biologics Cryoprecipitated AHF 6649425; 6649457; 6659087; 6659089; 6659092; 6659103; 6659109; 6659113; 6664719; 6665319; 6667046 Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. Community Blood Center of the Ozarks
Biologics Plasma Cryoprecipitate Reduced 6659087; 6659089; 6659092; 6659109; 6659132; 6665305 Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. Community Blood Center of the Ozarks
Biologics Red Blood Cells Irradiated 6653749; 6675572; 6677598 Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. Community Blood Center of the Ozarks
Biologics Red Blood Cells Leukocytes Reduced Irradiated 6657393; 6658379; 6662239; 6665764; 6666351; 6666704; 6672394; 6683753 Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. Community Blood Center of the Ozarks
Biologics Red Blood Cells Leukocytes Reduced 6631297; 6631298; 6631306; 6642075; 6644449; 6644454; 6644472; 6644477; 6644485; 6644490; 6645308; 6645310; 6645311; 6645336; 6648163; 6648184; 6648191; 6648194; 6648486; 6648493; 6648509; 6648643; 6648659; 6648664; 6650172; 6650426; 6653060; 6654801; 6654804; 6654813; 6654838; 6654841; 6654920; 6655131; 6655133; 6655145; 6655534; 6655715; 6655718; 6655719; 6656667; 6656682; 6656696; 6656713; 6656714; 6656747; 6656751; 6656769; 6656785; 6656828; 6657630; 6657643; 6657651; 6657678; 6657680; 6657772; 6657783; 6658045; 6659437; 6659448; 6659537; 6659564; 6661572; 6664688; 6664712; 6664719; 6664721; 6664727; 6664936; 6665732; 6665743; 6665760; 6665792; 6666390; 6668800; 6668802; 6669194; 6669397; 6669408; 6669450; 6669460; 6669489; 6670615; 6672311; 6672399; 6672406; 6672812; 6674206; 6674953; 6674978; 6674984; 6675016; 6675455; 6675571; 6675903; 6676347; 6676349; 6676355; 6676369; 6676371; 6676382; 6676391; 6676759; 6676768; 6677968; 6677971; 6677976; 6677979; 6677988; 6678025; 6678032; 6678045; 6678053; 6678058; 6678065; 6678089; 6682015; 6682088; 6682089; 6682229; 6682247; 6682248; 6682370; 6682374; 6682383; 6683403; 6683420; 6683422; 6683746; 6688102 Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. Community Blood Center of the Ozarks
Biologics Platelets 6631299; 6642184; 6648158; 6648165; 6648509; 6650155; 6650188; 6650472; 6650508; 6654804; 6654841; 6654846; 6654920; 6654940; 6655058; 6655074; 6655083; 6655089; 6655094; 6655096; 6655145; 6656667; 6656682; 6656696; 6656792; 6656804; 6656824; 6656842; 6657703; 6657772; 6657802; 6657804; 6657806; 6657809; 6658068; 6661565; 6661592; 6661601; 6661604; 6661612; 6661627; 6663323; 6664339; 6664390; 6664398; 6664409; 6664938; 6664946; 6665740; 6665743; 6665756; 6665764; 6665765; 6666373; 6666390; 6666401; 6666734; 6666759; 6666906; 6666909; 6666919; 6668800; 6668802; 6668807; 6669182; 6669397; 6669450; 6672678; 6672682; 6672683; 6672690; 6672697; 6672715; 6674946; 6674970; 6674972; 6675016; 6675560; 6675563; 6675888; 6675931; 6675973; 6676497; 6677563; 6677588; 6677597; 6677598; 6677979; 6678053; 6678065; 6678089; 6681181; 6681192; 6681204; 6681954; 6682248; 6682356; 6682365; 6682380; 6682387; 6682396; 6682399; 6682403; 6682406; 6682473; 6682478; 6682502; 6683014; 6683015; 6683018; 6683019; 6683173; 6683208; 6683212; 6683222; 6683386; 6683387; 6683400; 6683403; 6683746; 6683752; 6683753; 6685148; 6685153; 6685157; 6685181; 6685187; 6685190; 6688178; 6688196; 6688202; 6688768; 6688816; 6675013 Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. Community Blood Center of the Ozarks
Biologics Fresh Frozen Plasma 6659164; 6631297; 6642184; 6642186; 6642196; 6644449; 6644451; 6644472; 6644477; 6644483; 6644485; 6645305; 6645308; 6645310; 6645336; 6648165; 6648167; 6648685; 6648706; 6648710; 6648722; 6648725; 6650191; 6650472; 6650475; 6650496; 6650508; 6650509; 6653060; 6654920; 6654940; 6654957; 6655053; 6655058; 6655074; 6655083; 6655089; 6655094; 6655096; 6655525; 6656682; 6656710; 6656713; 6656731; 6656747; 6656751; 6656753; 6656768; 6656769; 6656785; 6656804; 6656806; 6657703; 6657705; 6657708; 6657711; 6657772; 6657783; 6657787; 6657802; 6657804; 6657806; 6657809; 6657812; 6658050; 6658068; 6658071; 6659158; 6661592; 6661604; 6661631; 6663341; 6664501; 6664938; 6664942; 6664946; 6665740; 6665743; 6665756; 6665766; 6666734; 6666759; 6666762; 6666906; 6666919; 6666938; 6666945; 6666973; 6667206; 6667215; 6667225; 6667265; 6668802; 6669182; 6669184; 6669397; 6669408; 6669450; 6669460; 6669489; 6672673; 6672678; 6672690; 6672697; 6672718; 6672727; 6672988; 6673598; 6674941; 6674946; 6674959; 6674970; 6674972; 6674977; 6674978; 6674980; 6674984; 6674996; 6675563; 6676483; 6676497; 6676499; 6676810; 6676811; 6677563; 6677567; 6677571; 6677588; 6677602; 6677979; 6678089; 6681181; 6681192; 6681204; 6681206; 6681604; 6681609; 6681612; 6681616; 6682224; 6682248; 6682383; 6682399; 6682473; 6682478; 6682502; 6683587; 6683592; 6683594; 6683615 Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. Community Blood Center of the Ozarks
Biologics Red Blood Cells 6631299; 6631302; 6642054; 6642061; 6642072; 6642077; 6642184; 6642186; 6642196; 6644447; 6644451; 6644483; 6645305; 6645315; 6645332; 6645343; 6647910; 6647911; 6647912; 6648158; 6648165; 6648167; 6648196; 6648206; 6648215; 6648216; 6648220; 6648457; 6648463; 6648481; 6648645; 6648681; 6648682; 6648685; 6648706; 6648710; 6648722; 6648725; 6648756; 6648759; 6648762; 6648832; 6649339; 6649344; 6649347; 6649352; 6649378; 6649405; 6649417; 6649421; 6649425; 6649457; 6650165; 6650169; 6650188; 6650191; 6650209; 6650404; 6650406; 6650408; 6650414; 6650422; 6650472; 6650473; 6650475; 6650486; 6650491; 6650496; 6650501; 6650508; 6650509; 6652910; 6652911; 6652912; 6652914; 6652915; 6653500; 6653503; 6653513; 6653746; 6654846; 6654940; 6654957; 6655053; 6655058; 6655062; 6655074; 6655081; 6655083; 6655089; 6655094; 6655096; 6655104; 6655122; 6655130; 6655520; 6655524; 6655525; 6655528; 6655531; 6656680; 6656681; 6656689; 6656707; 6656708; 6656710; 6656731; 6656753; 6656768; 6656790; 6656792; 6656804; 6656806; 6656807; 6656809; 6656824; 6656826; 6656831; 6656842; 6657394; 6657407; 6657423; 6657444; 6657447; 6657459; 6657461; 6657504; 6657512; 6657518; 6657535; 6657536; 6657540; 6657545; 6657556; 6657582; 6657599; 6657637; 6657641; 6657649; 6657670; 6657675; 6657688; 6657690; 6657692; 6657694; 6657697; 6657703; 6657705; 6657708; 6657711; 6657765; 6657766; 6657769; 6657770; 6657778; 6657785; 6657787; 6657802; 6657804; 6657806; 6657809; 6658028; 6658040; 6658050; 6658068; 6658071; 6658347; 6658366; 6658370; 6658385; 6658388; 6658391; 6659087; 6659089; 6659092; 6659096; 6659103; 6659106; 6659107; 6659109; 6659113; 6659132; 6659158; 6659159; 6659164; 6659353; 6659387; 6659477; 6659484; 6659519; 6659526; 6659534; 6659558; 6659567; 6659572; 6659577; 6659586; 6660751; 6660753; 6660771; 6660774; 6660778; 6660780; 6660790; 6660803; 6660811; 6661223; 6661233; 6661238; 6661258; 6661291; 6661296; 6661565; 6661568; 6661569; 6661579; 6661592; 6661601; 6661604; 6661606; 6661612; 6661627; 6661631; 6661785; 6661786; 6661794; 6662135; 6662137; 6662228; 6662229; 6662234; 6662242; 6662248; 6662252; 6662253; 6662255; 6662257; 6663204; 6663208; 6663212; 6663216; 6663312; 6663323; 6663341; 6663345; 6663779; 6663780; 6663783; 6663786; 6663797; 6663799; 6663803; 6663805; 6663819; 6663824; 6663826; 6663838; 6664279; 6664283; 6664289; 6664292; 6664298; 6664303; 6664324; 6664339; 6664357; 6664394; 6664398; 6664409; 6664482; 6664485; 6664487; 6664493; 6664501; 6664521; 6664698; 6664701; 6664703; 6664705; 6664714; 6664869; 6664872; 6664877; 6664901; 6664908; 6664938; 6664942; 6664946; 6664948; 6665305; 6665319; 6665382; 6665403; 6665422; 6665723; 6665728; 6665734; 6665736; 6665738; 6665740; 6665756; 6665765; 6665766; 6665774; 6665775; 6665776; 6665777; 6665778; 6665780; 6665787; 6665794; 6665796; 6665920; 6665921; 6665922; 6665931; 6665934; 6665941; 6665943; 6665957; 6666373; 6666401; 6666416; 6666734; 6666759; 6666762; 6666771; 6666906; 6666909; 6666919; 6666938; 6666945; 6666946; 6666969; 6666973; 6667046; 6667206; 6667215; 6667220; 6667225; 6667265; 6667275; 6667789; 6668807; 6669177; 6669182; 6669184; 6669211; 6669389; 6669394; 6669467; 6671004; 6671011; 6671019; 6671020; 6671022; 6671055; 6671060; 6671061; 6671064; 6672309; 6672392; 6672673; 6672678; 6672682; 6672683; 6672690; 6672697; 6672715; 6672718; 6672727; 6672802; 6672804; 6672805; 6672807; 6672808; 6672818; 6672988; 6673525; 6673584; 6673588; 6673589; 6673592; 6673595; 6673598; 6673599; 6673600; 6673601; 6673602; 6673762; 6673765; 6673768; 6673790; 6673791; 6673795; 6673797; 6673806; 6673808; 6673976; 6673977; 6673980; 6674219; 6674223; 6674259; 6674280; 6674292; 6674295; 6674934; 6674941; 6674944; 6674946; 6674959; 6674970; 6674977; 6674980; 6674996; 6674999; 6675456; 6675459; 6675469; 6675471; 6675560; 6675563; 6675574; 6675578; 6675581; 6675585; 6675600; 6675603; 6675606; 6675629; 6675630; 6675633; 6675878; 6675888; 6675925; 6675931; 6675939; 6675943; 6675950; 6675973; 6676000; 6676353; 6676482; 6676483; 6676484; 6676486; 6676492; 6676493; 6676496; 6676497; 6676499; 6676778; 6676790; 6676810; 6676811; 6676818; 6676823; 6676831; 6677328; 6677330; 6677331; 6677340; 6677561; 6677563; 6677567; 6677571; 6677588; 6677597; 6677602; 6677611; 6677630; 6677641; 6677642; 6677675; 6677679; 6677685; 6677695; 6677910; 6677913; 6677925; 6677927; 6677935; 6677937; 6681043; 6681048; 6681049; 6681181; 6681186; 6681192; 6681204; 6681206; 6681209; 6681212; 6681238; 6681378; 6681382; 6681385; 6681388; 6681522; 6681523; 6681524; 6681526; 6681576; 6681580; 6681600; 6681673; 6681681; 6681716; 6681719; 6681723; 6681724; 6681934; 6681936; 6681944; 6681947; 6681951; 6681954; 6681958; 6681975; 6681979; 6681986; 6681990; 6682020; 6682022; 6682024; 6682036; 6682038; 6682040; 6682055; 6682059; 6682061; 6682064; 6682080; 6682085; 6682100; 6682201; 6682204; 6682216; 6682224; 6682231; 6682233; 6682241; 6682284; 6682288; 6682294; 6682302; 6682307; 6682310; 6682312; 6682314; 6682317; 6682356; 6682365; 6682380; 6682385; 6682387; 6682396; 6682398; 6682399; 6682403; 6682406; 6682410; 6682466; 6682473; 6682476; 6682478; 6682494; 6682499; 6682502; 6682512; 6683019; 6683173; 6683179; 6683180; 6683182; 6683208; 6683212; 6683222; 6683243; 6683386; 6683387; 6683388; 6683390; 6683400; 6683587; 6683595; 6683597; 6683608; 6683755; 6688087; 6688104; 6688122; 6688178; 6688196; 6688213; 6688234; 6688756; 6688816 Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. Community Blood Center of the Ozarks
Biologics Red Blood Cells 5353013 Class II Blood products, with unacceptable, undocumented, or incomplete product QC, were distributed. New York Blood Center, Inc.
Biologics Fresh Frozen Plasma 5353013 Class II Blood products, with unacceptable, undocumented, or incomplete product QC, were distributed. New York Blood Center, Inc.
Biologics Red Blood Cells, Leukocyte Reduced 1159239 Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Hoxworth Blood Center University of Cincinnati Medical Center
Biologics Fresh Frozen Plasma 1159239 Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Hoxworth Blood Center University of Cincinnati Medical Center
Biologics Red Blood Cells Leukocytes Reduced 009FK67524;009GH72357;009GX55678;009FK67528; 009GH72361;009GX56251;009FK67530;009GH72370; 009GX56253;009FK67532;009GH72371;009GX56256; 009FK67534;009GH72378;009GX56261;009FK67536; 009GH72383;009GX56262;009FK67541;009GJ72636; 009GX56265;009FK67544;009GJ72641;009GX56270; 009FK67548;009GJ72645;009GX56272;009FK67551; 009GJ72648;009GX56275;009FK67555;009GJ72650; 009KG34257;009FK67557;009GJ72652;009KG34261; 009FK67559;009GJ72657;009KG34265;009FK67562; 009GJ73151;009KG34850;009FK67565;009GJ73154; 009KG34855;009FK68014;009GJ73161;009KG34856; 009FK68021;009GJ73179;009KG34862;009FV21440; 009GJ73189;009KG34878;009FV21442;009GJ73195; 009KG34883;009FV21445;009GJ73196;009KG34890; 009FV21498;009GJ73204;009KG34894;009FV21660; 009GJ73444;009KG34897;009FV21661;009GJ73447; 009KG35556;009FV21663;009GJ73453;009KG35561; 009FV21664;009GJ73458;009KG35570;009FV21666; 009GJ73465;009KG35574;009FV21667;009GJ74325; 009KG35577;009FV21671;009GJ74331;009KG35592; 009FV21674;009GJ74337;009KG35596;009FV21675; 009GJ74342;009KG35601;009FV21679;009GJ74408; 009KG35605;009FV21682;009GJ74533;009KG35610; 009FV22236;009GJ74538;009KG35614;009FV22237; 009GJ74547;009KG35615;009FV22239;009GJ74552; 009KG35724;009FV22242;009GJ74556;009KG35726; 009FV22243;009GJ74570;009KG35728;009FV22246; 009GJ74577;009KG35731;009FV22248;009GJ74589; 009KG35734;009FV22253;009GJ74580;009KG35735; 009FV22254;009GJ74583;009KG35738;009FV22255; 009GJ74592;009KG35740;009FV22257;009GJ74598; 009KG35742;009FV22258;009GJ74600;009KG35753; 009FV22261;009GJ74635;009KG35754;009FV22262; 009GJ74641;009KG35758;009FV22265;009GJ74645; 009KG35761;009FV22266;009GJ74647;009KG35763; 009FV22268;009GJ74650;009KG35767;009FV22270; 009GJ74652;009KG35892;009FV23223;009GJ74655; 009KG35905;009FV23234;009GJ74676;009KG35912; 009FV23244;009GJ74680;009KG35949;009FV23247; 009GJ74681;009KG35951;009FV23614;009GJ74683; 009KG35956;009FV23615;009GJ74687;009KG35961; 009FV23622;009GJ74688;009KG35962;009FV23623; 009GJ74691;009KG36778;009FV23624;009GJ74692; 009KG36779;009FV23626;009GJ74697;009KG36783; 009FV23630;009GJ74702;009KG36784;009FZ57832; 009GJ74704;009KG36788;009FZ57834;009GJ74706; 009KG36790;009FZ57840;009GR04276;009KG36792; 009FZ57842;009GR04279;009KG36793;009FZ57845; 009GR04282;009KG36796;009FZ57852;009GR04285; 009KG36798;009FZ57855;009GR04287;009KG36813; 009FZ57861;009GR04291;009KG36815;009FZ57865; 009GR04299;009KG36817;009GH70743;009GR04302; 009KG36832;009GH70746;009GR04305;009KG36845; 009GH70765;009GR04306;009KG36856;009GH70772; 009GR04637;009KG36859;009GH70778;009GR04646; 009KG36866;009GH70889;009GR04648;009KG36934; 009GH70892;009GR04650;009KG36941;009GH70896; 009GR04654;009KG36962;009GH71375;009GR04679; 009KG36965;009GH71379;009GR04682;009Q87153; 009GH71380;009GR04884;009Q87157;009GH71386; 009GR04887;009Q87169;009GH71397;009GR04888; 009Q87172;009GH71400;009GR04891;009Q87175; 009GH71409;009GR04892;009Q87177;009GH71418; 009GR04984;009Q87178;009GH71419;009GX55455; 009Q87182;009GH72002;009GX55457;009Q87186; 009GH72014;009GX55462;009Q87188;009GH72017; 009GX55466;009Q87189;009GH72026;009GX55469; 009Q88335;009GH72079;009GX55473;009Q88365; 009GH72083;009GX55475;009Q88367;009GH72233; 009GX55477;009Q88372;009GH72236;009GX55653; 009Q88375;009GH72240;009GX55658;009Q88375; 009GH72244;009GX55665;009Q88378;009GH72256; 009GX55668;009Q88381;009GH72261;009GX55670; 009Q88383;009GH72349;009GX55673;009Q88385 009Q88388 009Q88390 009Q88395 009Q88398 009Q88399 009Q88405 Class II Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed. American Red Cross Blood Services
Biologics Red Blood Cells Leukocytes Reduced Irradiated 009FK68018;009FZ57830;009FZ57863;009GH71412; 009GH72251;009GR04642;009GR04883;009GR04885; 009KG34879;009KG35535;009KG35620;009KG35621; 009KG35897;009KG35920;009Q87158;009Q88411 Class II Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed. American Red Cross Blood Services
Biologics Fresh Frozen Plasma 009GJ74600;009GJ74577;009GJ74645;009GJ74647; 009GJ74650 Class II Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed. American Red Cross Blood Services
Biologics Platelets Pheresis Leukocytes Reduced 7128661, 7125441, 7125468, 7227594, 7229093, 7229269, 7229699, 7229772, 7231367, 7234488. Class II Blood products, collected from a donor who emigrated from an area considered at risk for human immunodeficiency virus (HIV) Group O, were distributed. Lane Memorial Blood Bank
Biologics Cryoprecipitated AHF, Pooled 8000554, 8000567, 8000570, 8000572, 8000574, 8000575, 8000576, 8000581, 8000583, 8000589, 8000603, 8000611, 8000613, 8000624, 8000646, 8000648, 8000652, 8000658, 8000672, 8000678. Class II Blood products, collected from a donor who emigrated from an area considered at risk for human immunodeficiency virus (HIV) Group O, were distributed. Lane Memorial Blood Bank
Biologics Red Blood Cells, Leukocytes Reduced 7126037, 7126851, 7231541, 7233722, 7427262, 7428103, 7428115, 7428185, 7428187, 7428237, 7428238, 7428253, 7428259, 7428600, 7428672, 7429322, 7429567, 7432600, 7126394, 7428520, 7429211, 7126153, 7430972, 7430291, 7433622, 7130041, 7230313, 7231344, 7231852, 7429968, 7431818, 7432498, 7433768, 7433777, 7434213, 7434544, 7434564, 7436396, 7436397, 7125583, 7125987, 7126505, 7126628, 7126785, 7127086, 7127154, 7127314, 7127414, 7127430, 7127442, 7127600, 7127854, 7128317, 7129588, 7130255, 7130711, 7131415, 7131976, 7227278, 7228058, 7228132, 7228479, 7228512, 7228520, 7228571, 7228682, 7229235, 7229305, 7229507, 7229775, 7229793, 7230034, 7230109, 7230326, 7230801, 7231028, 7231162, 7231714, 7232224, 7232363, 7232640, 7232746, 7232986, 7233600, 7233993, 7235656, 7427539, 7427541, 7427770, 7427776, 7427801, 7428067, 7428135, 7428155, 7428399, 7428410, 7428574, 7428619, 7428642, 7428665, 7428718, 7428841, 7428843, 7428845, 7428850, 7428871, 7428876, 7428907, 7428922, 7428944, 7428963, 7429038, 7429059, 7429091, 7429107, 7429544, 7430381, 7430435, 7430561, 7430747, 7430753, 7430757, 7430908, 7430920, 7430960, 7430963, 7431078, 7431132, 7431174, 7431216, 7431960, 7431970, 7432011, 7432018, 7432144, 7432314, 7432344, 7432376, 7432382, 7432604, 7432617, 7432965, 7433050, 7433144, 7433176, 7433302, 7433358, 7433372, 7433516, 7433548, 7433598, 7433798, 7433816, 7433948, 7434078, 7434137, 7434139, 7434157, 7434233, 7434249, 7434411, 7434428, 7434469, 7434599, 7434638, 7434759, 7435309, 7435312, 7435536, 7435749, 7436205, 7436363, 7436373, 7436393, 7436404, 7436775, 7436782, 7125729, 7126175, 7127324, 7127501, 7127773, 7129349, 7130170, 7130942, 7130984, 7131027, 7227031, 7227368, 7228048, 7228635, 7228656, 7228898, 7229328, 7229363, 7229364, 7229836, 7230618, 7231092, 7231415, 7231782, 7232332, 7232417, 7232510, 7232647, 7232794, 7233393, 7234472, 7234473, 7235040, 7235840, 7427385, 7427392, 7427522, 7427586, 7427880, 7428062, 7428069, 7428100, 7428213, 7428240, 7428251, 7428264, 7428268, 7428270, 7428376, 7428388, 7428394, 7428557, 7428738, 7428806, 7428809, 7428936, 7428965, 7428967, 7428979, 7429123, 7429200, 7429203, 7429209, 7429352, 7429911, 7430051, 7430166, 7430359, 7430428, 7430858, 7430913, 7431160, 7431289, 7431636, 7431785, 7432242, 7432322, 7432530, 7432881, 7432898, 7433118, 7433265, 7433412, 7433945, 7434261, 7434392, 7434439, 7434604, 7435003, 7435005, 7435205, 7435210, 7435444, 7435892, 7436214, 7436383, 7436399, 7125559, 7125614, 7126318, 7126398, 7126501, 7126509, 7126548, 7227268, 7227507, 7227866, 7227973, 7228021, 7228126, 7228395, 7228422, 7228859, 7229060, 7427147, 7427343, 7427369, 7427374, 7427394, 7427396, 7427399, 7427437, 7427438, 7427469, 7427582, 7427587, 7427601, 7427858, 7427948, 7428024, 7428027, 7428036, 7428203, 7428205, 7428229, 7428231, 7428306, 7428332, 7428499, 7428542, 7428563, 7428584, 7428587, 7428689, 7428694, 7428696, 7428826, 7428831, 7428834, 7428846, 7428855, 7428864, 7428866, 7429172, 7429181, 7429187, 7429191, 7429205, 7429210, 7429441, 7429465, 7125279, 7125367, 7125400, 7125457, 7125625, 7125651, 7125672, 7125817, 7125976, 7126000, 7126056, 7126133, 7126262, 7126301, 7126308, 7126344, 7126349, 7126364, 7126481, 7126488, 7126541, 7126598, 7126627, 7126783, 7126818, 7126819, 7126878, 7127099, 7127119, 7127131, 7127170, 7127310, 7127370, 7127406, 7127408, 7127488, 7127489, 7127535, 7127576, 7127615, 7127802, 7127809, 7127915, 7127929, 7128582, 7128635, 7128651, 7128849, 7129022, 7129026, 7129028, 7129034, 7129128, 7129449, 7129843, 7129884, 7129900, 7129911, 7130005, 7130065, 7130195, 7130253, 7130467, 7130473, 7130558, 7130624, 7130646, 7130708, 7130772, 7130884, 7130983, 7131235, 7131346, 7131712, 7131966, 7226975, 7227201, 7227471, 7227619, 7227648, 7227729, 7227770, 7227813, 7227821, 7228037, 7228042, 7228061, 7228063, 7228089, 7228092, 7228122, 7228191, 7228198, 7228311, 7228351, 7228392, 7228482, 7228526, 7228642, 7228648, 7228722, 7228771, 7228818, 7228824, 7228868, 7228948, 7228953, 7228962, 7229231, 7229272, 7229323, 7229349, 7229396, 7229427, 7229488, 7229723, 7229799, 7229972, 7229990, 7230103, 7230229, 7230420, 7230487, 7230524, 7230649, 7230650, 7230671, 7231059, 7231096, 7231102, 7231126, 7231145, 7231153, 7231224, 7231300, 7231303, 7231820, 7231892, 7232595, 7232619, 7232641, 7232757, 7232827, 7232832, 7232910, 7232915, 7232987, 7233084, 7233125, 7233133, 7233145, 7233207, 7233330, 7233347, 7233452, 7233461, 7233571, 7233599, 7233686, 7233707, 7233887, 7234194, 7234350, 7234358, 7234700, 7234870, 7234877, 7234893, 7235188, 7235321, 7235381, 7235414, 7235732, 7236361, 7236733, 7427149, 7427170, 7427229, 7427327, 7427339, 7427361, 7427390, 7427406, 7427441, 7427442, 7427468, 7427529, 7427530, 7427531, 7427584, 7427637, 7427649, 7427673, 7427727, 7427736, 7427743, 7427752, 7427756, 7427764, 7427767, 7427772, 7427894, 7427895, 7427896, 7427899, 7427901, 7427903, 7427946, 7427986, 7428000, 7428009, 7428049, 7428063, 7428068, 7428089, 7428113, 7428142, 7428216, 7428232, 7428236, 7428247, 7428252, 7428260, 7428272, 7428277, 7428287, 7428300, 7428318, 7428346, 7428347, 7428396, 7428466, 7428500, 7428501, 7428509, 7428522, 7428531, 7428533, 7428534, 7428538, 7428552, 7428554, 7428560, 7428562, 7428570, 7428571, 7428590, 7428591, 7428596, 7428606, 7428607, 7428610, 7428612, 7428616, 7428626, 7428658, 7428659, 7428664, 7428666, 7428673, 7428680, 7428706, 7428707, 7428713, 7428728, 7428730, 7428731, 7428740, 7428751, 7428759, 7428792, 7428800, 7428808, 7428812, 7428817, 7428890, 7428910, 7428918, 7428923, 7428928, 7428933, 7428937, 7428938, 7428939, 7428945, 7428948, 7428953, 7428956, 7428969, 7428972, 7428985, 7428990, 7428991, 7428996, 7429011, 7429022, 7429051, 7429087, 7429092, 7429094, 7429095, 7429096, 7429099, 7429111, 7429117, 7429118, 7429119, 7429127, 7429145, 7429150, 7429160, 7429206, 7429208, 7429212, 7429215, 7429216, 7429245, 7429253, 7429254, 7429288, 7429307, 7429417, 7429423, 7429429, 7429439, 7429457, 7429464, 7429471, 7429477, 7429491, 7429585, 7429587, 7429657, 7429663, 7429674, 7429725, 7429853, 7429861, 7429874, 7429875, 7429899, 7429900, 7429907, 7429909, 7430032, 7430035, 7430088, 7430098, 7430107, 7430123, 7430144, 7430159, 7430170, 7430175, 7430176, 7430187, 7430198, 7430237, 7430238, 7430248, 7430318, 7430321, 7430343, 7430347, 7430352, 7430353, 7430414, 7430487, 7430554, 7430558, 7430660, 7430748, 7430796, 7430813, 7430828, 7430834, 7430840, 7430878, 7430911, 7430935, 7430955, 7430965, 7430998, 7431009, 7431014, 7431031, 7431033, 7431049, 7431050, 7431052, 7431054, 7431058, 7431059, 7431062, 7431065, 7431069, 7431093, 7431117, 7431191, 7431197, 7431209, 7431265, 7431318, 7431478, 7431501, 7431517, 7431569, 7431584, 7431645, 7431677, 7431696, 7431718, 7431727, 7431751, 7431754, 7431760, 7431762, 7431770, 7431773, 7431794, 7431817, 7431895, 7431907, 7431910, 7431935, 7431936, 7431944, 7432012, 7432032, 7432088, 7432089, 7432142, 7432168, 7432172, 7432182, 7432187, 7432274, 7432317, 7432324, 7432413, 7432499, 7432508, 7432526, 7432539, 7432563, 7432662, 7432690, 7432691, 7432692, 7432696, 7432699, 7432719, 7432725, 7432762, 7432773, 7432778, 7432927, 7432937, 7432966, 7432983, 7432993, 7433003, 7433013, 7433075, 7433112, 7433114, 7433127, 7433368, 7433458, 7433495, 7433507, 7433508, 7433596, 7433616, 7433617, 7433647, 7433760, 7434079, 7434098, 7434099, 7434155, 7434346, 7434377, 7434545, 7434550, 7434683, 7434688, 7434761, 7434932, 7434946, 7435012, 7435021, 7435070, 7435096, 7435320, 7435423, 7435439, 7435512, 7435618, 7435637, 7435661, 7435997, 7436081, 7436197, 7436260, 7436261, 7436367, 7436401, 7436413, 7436472, 7436499, 7436543, 7436706, 7436861, 7436994, 7437188, 7600012, 7600055, 7600059, 7600121, 7600125, 7600127, 7600130, 7600147, 7126350, 7126375, 7126900, 7127274, 7127299, 7128407, 7227227, 7227672, 7228301, 7228374, 7228606, 7230906, 7234715, 7236689, 7427094, 7427928, 7427929, 7428445, 7428456, 7428459, 7428461, 7428463, 7428469, 7428481, 7428489, 7428676, 7428747, 7428758, 7428902, 7428940, 7429048, 7430211, 7430219, 7432253, 7432828, 7433837, 7436480, 7129886, 7430684, 7233549, 7235338, 7433149. Class II Blood products, collected from a donor who emigrated from an area considered at risk for human immunodeficiency virus (HIV) Group O, were distributed. Lane Memorial Blood Bank
Biologics Fresh Frozen Plasma 7433003, 7427598, 7126000, 7129884, 7129900, 7129911, 7227001, 7229972, 7230034, 7230618, 7231303, 7231892, 7232394, 7232746, 7427094, 7429022, 7429417, 7431031, 7431970, 7435205, 7125625, 7125928, 7126034, 7126056, 7126364, 7126375, 7126398, 7127086, 7127170, 7127274, 7127310, 7127370, 7127600, 7127773, 7127854, 7129022, 7129026, 7129034, 7129449, 7129588, 7129843, 7129886, 7130195, 7130253, 7131235, 7227171, 7227201, 7227507, 7228351, 7228392, 7228859, 7229272, 7229323, 7229349, 7229364, 7229488, 7229723, 7229799, 7230109, 7230650, 7231162, 7231300, 7231344, 7231415, 7232619, 7232986, 7233571, 7233686, 7233707, 7235321, 7235381, 7235414, 7427055, 7427113, 7427170, 7427293, 7427482, 7427600, 7427601, 7427612, 7427929, 7428062, 7428065, 7428075, 7428103, 7428229, 7428231, 7428232, 7428388, 7428410, 7428459, 7428846, 7428851, 7428902, 7428918, 7428956, 7428963, 7428969, 7428991, 7429206, 7429208, 7429288, 7429423, 7429657, 7429875, 7429900, 7429911, 7430051, 7430123, 7430955, 7430963, 7431033, 7431078, 7431478, 7431569, 7431785, 7432089, 7432142, 7432144, 7432242, 7432253, 7432344, 7432662, 7432692, 7432699, 7432719, 7432773, 7432778, 7432828, 7433050, 7433075, 7433112, 7433114, 7433118, 7433127, 7433144, 7433176, 7433495, 7433507, 7433508, 7433516, 7433596, 7433617, 7433647, 7433677, 7433945, 7434078, 7434098, 7434099, 7434137, 7434139, 7434155, 7434469, 7434761, 7435005, 7435210, 7435661, 7435997, 7436543, 7600127, 7600130, 7233549, 7235338, 7126505, 7130473, 7131976, 7229363, 7230671, 7428552. Class II Blood products, collected from a donor who emigrated from an area considered at risk for human immunodeficiency virus (HIV) Group O, were distributed. Lane Memorial Blood Bank
Biologics Red Blood Cells 7125234, 7125397, 7125784, 7227088, 7227333, 7427134, 7427141, 7427411, 7427566, 7427775, 7427808, 7427841, 7428040, 7428099, 7428112, 7125231, 7125263, 7125557, 7125692, 7125759, 7125928, 7126034, 7226962, 7227039, 7227305, 7227399, 7227534, 7427067, 7427113, 7427591, 7427598, 7427617, 7427624, 7427738, 7427755, 7427867, 7427889, 7427904, 7427945, 7428030, 7428056, 7428064, 7428139, 7428160, 7125556, 7227359, 7228335, 7427216, 7427554, 7427563, 7427784, 7427866, 7427888, 7427890, 7427891, 7427897, 7427907, 7428017, 7428058, 7125243, 7125274, 7125290, 7125447, 7125517, 7125632, 7125834, 7226952, 7226982, 7227001, 7227012, 7227024, 7227087, 7227156, 7227166, 7227171, 7227252, 7227413, 7227527, 7227631, 7227831, 7227832, 7227917, 7228007, 7427055, 7427073, 7427083, 7427099, 7427102, 7427142, 7427143, 7427151, 7427155, 7427173, 7427200, 7427215, 7427220, 7427231, 7427252, 7427253, 7427278, 7427283, 7427293, 7427306, 7427412, 7427419, 7427420, 7427425, 7427482, 7427502, 7427546, 7427548, 7427551, 7427569, 7427576, 7427589, 7427590, 7427592, 7427593, 7427600, 7427612, 7427721, 7427722, 7427740, 7427741, 7427760, 7427778, 7427780, 7427792, 7427794, 7427847, 7427871, 7427887, 7427898, 7427905, 7427947, 7427951, 7427959, 7427994, 7428001, 7428065, 7428075, 7428087, 7428102, 7428150, 7600026, 7427280, 7227235. Class II Blood products, collected from a donor who emigrated from an area considered at risk for human immunodeficiency virus (HIV) Group O, were distributed. Lane Memorial Blood Bank
Biologics Platelets Pheresis 7230082, 7230082. Class II Blood products, collected from a donor who emigrated from an area considered at risk for human immunodeficiency virus (HIV) Group O, were distributed. Lane Memorial Blood Bank
Biologics Red Blood Cells Leukocytes Reduced 42FG97856; 42FX18928; 42FS77056; 42FW04560; 42FS77179; 42T14091; 42FW07587; 42FE77508; 42X69153; 42FT30987; 42FT32094; 42FT33242; 42Q80247; 42FX23314; 42FW14032; 42Y40592; 42K62728; 42FW15079; 42FP95695; 42T21726; 42FY46506; 42GC04041; 42FP95993; 42FW16055; 42FW16474; 42FJ17909; 42FY47360; 42E44031; 42GC04913; 42K65715; 42GC05249; 42K67824; 42GE10615; 42J50877; 42GE13124; 42K72330; 42FE88710; 42FX31697; 42FY54263; 42L17022; 42FE89129; 42FR09116; 42L17139; 42FY54595; 42FP01778; 42FC14745; 42FR09262; 42S01248; 42FP01855; 42FS86720; 42FT48521; 42T29128; 42GC09331; 42T29166; 42FE89487; 42FY54962; 42FJ25411; 42R75970; 42FJ25415; 42FJ25426; 42FP02096; 42FR09541; 42S01299; 42FP02164; 42FS87036; 42FE89738; 42X93965; 42R76080; 42K73873; 42FY55530; 42FW24320; 42FT49145; 42FH30943; 42G51800; 42H42656; 42L18182; 42X95754; 42L18885; 42FW25808; 42J54932; 42T31952; 42GS00091; 42FY58222; 42X97267; 42FX37195; 42T33419; 42FT51218; 42FR13746; 42J56320; 42X99784; 42J56672; 42GS02007; 42FX38429; 42K77697; 42FJ29389; 42GS02147; 42FT52111; 42GS02320; 42T34299; 42R79190; 42GC12641; 42FH35085; 42GS02509; 42J57025; 42T34535; 42FR14728; 42FX39460; 42FH35912; 42FR16537; 42K79507; 42FP07542; 42GS05379; 42FP08044; 42FG15013; 42FH38035; 42H45608; 42S09475; 42FR19529; 42T38927; 42J60615; 42R82601; 42FH38847; 42FX44325; 42FR20428; 42G57322; 42GE20896; 42FC20185; 42J62490; 42G57855; 42FY65616; 42GT06076; 42X11341; 42S13088; 42FR23408; 42X12294; 42G58827; 42J65036; 42J65656; 42GC19207; 42GC19403; 42J66118; 42FY68678; 42R87050; 42S16700; 42GE23950; 42S15779; 42FQ30098; 42S15858; 42W46282; 42J67374; 42FR27493; 42GE24867; 42J67510; 42FX51450; 42GT09019; 42FW28723; 42FW28741; 42FG21636; 42FX51795; 42GS14057; 42FP17550; 42FK72737; 42S17380; 42K86097; 42L33714; 42GS14524; 42FY70348; 42W46697; 42W46920; 42FR28885; 42FF00777; 42FY70871; 42FS94875; 42K88149; 42FT66986; 42GC22493; 42FK73459; 42GS16278; 42FH46147; 42FS95385; 42FJ41705; 42GT11407; 42T47055; 42FG24377; 42FP21685; 42GE28365; 42GS18470; 42K90300; 42R91583; 42G63752; 42FH48245; 42FY73968; 42GC24357; 42FP22670; 42FK74477; 42FW34872; 42FW34918; 42FH48985; 42FW34999 Class II Blood products, which were not screened for antibodies according to the reagent manufacturer's instructions, were distributed. American National Red Cross (The)
Biologics Platelets Pheresis Leukocytes Reduced 42KP12009; 42KW21131; 42KW23881; 42KW32826; 042KW33193 Class II Blood products, which were not screened for antibodies according to the reagent manufacturer's instructions, were distributed. American National Red Cross (The)
Biologics Red Blood Cells 42FZ04668; 42FQ07085; 42G40637; 42Q78142; 42K57455; 42X70520; 42GC01832; 42FY42018; 42S96094; 42G43536; 42FE80206; 42GC03025; 42FP94339; 42FC12027; 42H38306; 42G45141; 42R70525; 42K63770; 42GF00087; 42GC04186; 42X79525; 42FX25436; 42F57319; 42FE85263; 42H42171; 42GC07199; 42K69861; 42GQ00947; 42GE12459;42R75067; 42FR08846; 42K72538; 42FF87015; 42GW00822; 42H41922; 42H42001; 42FT47934; 42G50965; 42FX32315; 42FY54715; 42FH29950; 42FH29952; 42FE89385; 42FG08750; 42FZ04668; 42FX32821; 42W37413; 42FE89690; 42FK67898; 42FF87745; 42FQ18227; 42FE89800; 42R76089; 42FX33179; 42FF87875; 42FR10445; 42FC15239; 42FZ05440; 42L18360; 42H42959; 42GW01149; 42FW25652; 42GW01166; 42G52689; 42R77333; 42W39053; 42FP04088; 42FE92188; 42GQ02161; 42F59943; 42FP04467; 42FF89640; 42FQ20201; 42FX37359; 42FY58678; 42FG12022; 42J56537; 42S04645; 42FX38323; 42FG12246; 42X00136; 42F60609; 42W40533; 42FP05906; 42FC16758; 42GE17473; 42W40923; 42R80473; 42FR17226; 42L24243; 42FG14862; 42H45314; 42S08856; 42FC18434; 42R81577; 42GS06844; 42FK70290; 42GK01123; 42L25375; 42FP09719; 42L26574; 42J61392; 42GW02619; 42GT05538; 42GS08851; 42FX45740; 42T41101; 42FX47488; 42FK71589; 42FG19047; 42GW03072; 42GS11320; 42FC21422; 42GW03167; 42FK72004; 42T43436; 42FQ29372; 42M21467; 42L31825; 42R87247; 42FR26882; 42GQ01660; 42GW03782; 42GW03913; 42FF02862; 42GK01702 Class II Blood products, which were not screened for antibodies according to the reagent manufacturer's instructions, were distributed. American National Red Cross (The)
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 42C18441; 42E48391; 42E48501; 42GX00897; 42N21930; 42Y48405; 42FN17577 Class II Blood products, which were not screened for antibodies according to the reagent manufacturer's instructions, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Removed Washed 42FG09596 Class II Blood products, which were not screened for antibodies according to the reagent manufacturer's instructions, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Deglycerolized 42GQ00737 Class II Blood products, which were not screened for antibodies according to the reagent manufacturer's instructions, were distributed. American National Red Cross (The)
Biologics Platelets Pheresis Leukocytes Reduced 4737455A; 4737455B; 4737432A; 4737432B; 4737442A; 4737442B; 4737442C. Class II Blood products, which did not meet the acceptable product specifications, were distributed. Northwest Florida Blood Center, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced Unit numbers 5213976A; 5213976B. Class III Blood products, which did not meet the acceptable product specifications, were distributed. Northwest Florida Blood Center, Inc.
Biologics Red Blood Cells 4825254 Class II Blood products, collected from a donor whose close contact with partner who emigrated from an area at risk for HIV-Group O, were distributed. Florida Georgia Blood Alliance, Inc.
Biologics Platelets 4825254 Class II Blood products, collected from a donor whose close contact with partner who emigrated from an area at risk for HIV-Group O, were distributed. Florida Georgia Blood Alliance, Inc.
Biologics Fresh Frozen Plasma 4825254 Class II Blood products, collected from a donor whose close contact with partner who emigrated from an area at risk for HIV-Group O, were distributed. Florida Georgia Blood Alliance, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 01GH09575; 01KS81880 Class III Blood products, which may have been exposed to unacceptable temperature during storage, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 01GE68894; 01GE67226; 01GE68077; 01GE63062 Class II Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed. American National Red Cross (The)
Devices Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure). Models: ICON Auto: ICONAAN, ICONAAN-HT, ICONAAJ. ICON Novo: ICONNAN, ICONNAN-HT, ICONNAJ. ICON Premo: ICONPBN, ICONPBN-HT, ICONPBN-HTC. The ICON CPAP unit is for use on adult patients for the treatment of Obstructive Sleep Apnea (OSA). The device is for use in the home or sleep laboratory. The device is not intended to be used as a life supporting device. Lot 121210: December 10th, 2012. Lot 121221: December 21st, 2012. Class II Fisher and Paykel Healthcare is recalling the ICON CPAP units because there is a potential power issue on certain ICON CPAP. These ICON CPAP units could potentially become inoperable, which would result in a lack of treatment to the patient's obstructive sleep apnea symptoms until a replacement unit is obtained. Fisher & Paykel Healthcare, Ltd.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 01KL11353 Class II Blood product, which may have been contaminated during collection, was distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 01KM46955 Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. American National Red Cross (The)
Biologics Platelets Leukocytes Reduced 01KM46955 Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. American National Red Cross (The)
Biologics Plasma Frozen 01KM46955 Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced W127808500548, W127808500549, W127808500555, W127808500568, W127808500584, W127808500589, N 22878, N 22883, V 72291. Class III Blood products, collected using a copper sulfate solution which had unacceptable specific gravity QC results were distributed. Tacoma Pierce County Blood Bank
Biologics Red Blood Cells W127808500544, W127808500546, W127808500550, W127808500551, W127808500556, W127808500558, W127808500562, W127808500565, W127808500567, W127808500569, W127808500572, W127808500573, W127808500575, W127808500577, W127808500579, W127808500580, W127808500582, W127808500583, W127808500587, W127808500588, N 22876, N 22880, N 22881, V 72286, V 72287, V 72288, V 72292, V 72293, V 72294. Class III Blood products, collected using a copper sulfate solution which had unacceptable specific gravity QC results, were distributed. Tacoma Pierce County Blood Bank
Biologics Red Blood Cells Leukocytes Reduced Irradiated W127808500543, W127808500547, W127808500570, W127808500574, W127808500578, W127808500581, W127808500585, N 22879 Class III Blood products, collected using a copper sulfate solution which had unacceptable specific gravity QC results, were distributed. Tacoma Pierce County Blood Bank
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 009FC30192; 009GP38408; 009FC30192; 009GP38408; 009FC30202; 009GP38509; 009FC30205; 009GP38509; 009FC30205; 009GP38510; 009FC30548; 009GP38513; 009FC30548; 009GP38513; 009FC30559; 009GP38514; 009FC30559; 009GP38514; 009FC30562; 009GP38529; 009FC30562; 009GP38536; 009FC30567;009GP38536; 009FC30567; 009GP38537; 009FC30585; 009GP38537; 009FC30585; 009GP38713; 009FC30608; 009GP38713; 009FC30608; 009GP38722; 009FC30611; 009GP38722; 009FC30613; 009GP38765; 009FC30614; 009GP38765; 009FC30617; 009GP38778; 009FC30617; 009GP38778; 009FC30686; 009GP38790; 009FC30686; 009GP38790; 009FC30702; 009GP38791; 009FC30702; 009GP38791; 009FC30704; 009GP38845; 009FC30704; 009GP38848; 009FC30707; 009GP38848; 009FC30707; 009GP38858; 009GP38367; 009GP38858; 009GP38367; 009KE16379; 009GP38376; 009GP38376; 009GP38384; 009GP38384; 009GP38394; 009GP38394 Class II Blood products, labeled 'leukocytes reduced' which did not meet the QC requirements for leukoreduced products, were distributed. American Red Cross Blood Services
Biologics Source Plasma 367034032, 367034336, Class II Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed. Talecris Plasma Resources, Inc.
Biologics Source Plasma PQ071610; PQ071249; PQ070893; PQ070094; PQ069852; PQ069370; PQ069143; PQ068762; PQ068560; PQ068072; PQ067943; PQ066719; PQ066061; PQ065980; PQ065418; PQ065379; PQ064784; PQ064274; PQ063587; PQ061774; PQ060955; PQ060615; PQ060331; PQ059896; PQ059735; PQ057946; PQ057755; PQ057245; PQ057087; PQ056562; PQ056469 Class II Blood products, collected from a donor who was previously deferred for possibly exposure to vCJD, were distributed. Plasma Biological Services Inc
Biologics Platelets Pheresis Leukocytes Reduced Irradiated 011LS57296;011LS57296;011LS57303;011LS57311; 011LS57324;011LS57324;011LS57311;011LS57296; 011LS57354;011LS57354 Class II Blood products, collected using equipment that had not been validated, were distributed. American Red Cross Blood Services
Biologics Platelets Pheresis Leukocytes Reduced 011LS57298; 011LS57298; 011LS57298; 011LS57301; 011LS57301; 011LS57301; 011LS57303; 011LS57308; 011LS57311; 011LS57315; 011LS57315; 011LS57319; 011LS57324; 011LS57330; 011LS57349; 011LS57358; 011LS57358; 011LS57330; 011LS57324; 011LS57319; 011LS57354; 011LS57308; 011LS57349; 011LS57338; 011LS57363; 011LS57361; 011LS57330 Class II Blood products, collected using equipment that had not been validated, were distributed. American Red Cross Blood Services
Biologics Red Blood Cells Leukocytes Reduced 011LS57368; 011LS57364; 011LS57327; 011LS57338 Class II Blood products, collected using equipment that had not been validated, were distributed. American Red Cross Blood Services
Biologics Source Plasma MQ086809; MQ086137; MQ085668; MQ084840; MQ084732; MQ083488; MQ082531; MQ081187; MQ080888; MQ079861; MQ079318; MQ077682; MQ076813; MQ075820; MQ075570; MQ074794; MQ074060; MQ073403; MQ073078; MQ072489; MQ072067; MQ071694; MQ071390; MQ071115; MQ070687; MQ070398; MQ070025; MQ069544; MQ069344 Class II Blood products, collected from a donor who was previously deferred after receiving a tattoo within a year of donating, were distributed. Plasma Biological Services Inc
Food Preserved Apricots -- NET WEIGHT 300gr (10.6oz) -- Ingredient: Salt, apricot, refined sugar. Firm on label: packed for Hong Lee Trading Inc., 225 Johnson Ave., Brooklyn, NY 11203. Product of Vietnam. No codes Class I The product contained undeclared sulfites (108.8 ppm) and undeclared Yellow #5 based on sampling and analysis by New York State Department of Agriculture and Markets. Hong Lee Trading Inc
Devices Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4", Part Number 2090-0502 Product Usage: Facilitate placement of bone cement in weakened or diminished bone Manufacturer Part Number 2090-0502, Lot Number Q1006003 Class II There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use. Orthovita, Inc., dBA Stryker Orthobiologics.
Devices Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 6", Part Number 2090-0505 Product Usage: Facilitate placement of bone cement in weakened or diminished bone Manufacturer Part Number 2090-0505, Lot Number A1006027 Class II There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use. Orthovita, Inc., dBA Stryker Orthobiologics.
Devices Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4", Part Number 2090-0501 Product Usage: Facilitate placement of bone cement in weakened or diminished bone Manufacturer Part Number 2090-0501, Lot Numbers A1109035 and Q1006002 Class II There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use. Orthovita, Inc., dBA Stryker Orthobiologics.
Devices Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Syringe Delivery System, 6", Part Number 2090-0504 Product Usage: Facilitate placement of bone cement in weakened or diminished bone Manufacturer Part Number 2090-0504, Lot Numbers A1006026 and A1111020 Class II There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use. Orthovita, Inc., dBA Stryker Orthobiologics.
Devices Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 4", Part Number 2110-0505 Product Usage: Facilitate placement of bone cement in weakened or diminished bone Manufacturer Part Number 2110-0505, Lot Numbers E909002 and E909002R Class II There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use. Orthovita, Inc., dBA Stryker Orthobiologics.
Devices Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 8", Part Number 2110-0526 Product Usage: Facilitate placement of bone cement in weakened or diminished bone Manufacturer Part Number 2110-0526, Lot Numbers E908004R and E908004 Class II There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use. Orthovita, Inc., dBA Stryker Orthobiologics.
Devices Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 6", Part Number 2110-0501 Product Usage: Facilitate placement of bone cement in weakened or diminished bone Manufacturer Part Number 2110-0501, Lot Numbers E909004R and E909004 Class II There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use. Orthovita, Inc., dBA Stryker Orthobiologics.
Devices Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Diamond Needle, 4", Part Number 2110-0506 Product Usage: Facilitate placement of bone cement in weakened or diminished bone Manufacturer Part Number 2110-0506, Lot Number E909005R Class II There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use. Orthovita, Inc., dBA Stryker Orthobiologics.
Devices Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 8", Part Number 2110-0525 Product Usage: Facilitate placement of bone cement in weakened or diminished bone Manufacturer Part Number 2110-0525, Lot Numbers E909006R Class II There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use. Orthovita, Inc., dBA Stryker Orthobiologics.
Devices Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 6", Part Number 2110-0504 Product Usage: Facilitate placement of bone cement in weakened or diminished bone Manufacturer Part Number 2110-0504, Lot Number E909007R Class II There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use. Orthovita, Inc., dBA Stryker Orthobiologics.
Devices Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 8", Part Number 2110-0502 Product Usage: Facilitate placement of bone cement in weakened or diminished bone Manufacturer Part Number 2110-0502, Lot Number E909008R Class II There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use. Orthovita, Inc., dBA Stryker Orthobiologics.
Devices Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 6", Part Number 2110-0524 Product Usage: Facilitate placement of bone cement in weakened or diminished bone Manufacturer Part Number 2110-0524, Lot Number E909009R and E909009R Class II There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use. Orthovita, Inc., dBA Stryker Orthobiologics.
Devices Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 6", Part Number 2110-0503 Product Usage: Facilitate placement of bone cement in weakened or diminished bone Manufacturer Part Number 2110-0503, Lot Numbers E908003R and E908002 Class II There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use. Orthovita, Inc., dBA Stryker Orthobiologics.
Food Whole Foods Mini Peanut Butter Cookies 12 pack sold in small, plain brown bags featuring a cellophane window on the front with an oval Whole Foods Market sticker that reads "mini peanut butter cookies - OLD-FASHIONED TREATS FROM WHOLE FOOD MARKET-" PLU 22096100000 All cookies sold before September 29, 2012, manufactured from May 1, 2012 to September 24, 2012 Class I The cookies were manufactured using peanut butter recalled by Sunland, Inc. for salmonella The Sourdough: A European Bakery Inc.
Food Whole Foods 3 oz Peanut Butter Cookies sold under PLU 47963 from the retail store self-serve pastry case. All cookies sold before September 29, 2012, manufactured from May 1, 2012 to September 24, 2012, Class I The cookies were manufactured using peanut butter recalled by Sunland, Inc. for salmonella. The Sourdough: A European Bakery Inc.
Food Whole Foods 3 oz Peanut Butter Chocolate Chunk Cookies sold under PLU 47963 from the retail store self-serve pastry case. All cookies sold before September 29, 2012, manufactured from May 1, 2012 to September 24, 2012. Class I The cookies were manufactured using peanut butter recalled by Sunland, Inc. for salmonella. The Sourdough: A European Bakery Inc.
Food Peanut Butter Ribbon, 40 lb Pail, Item Numbers 07-012-40, 07-212-40, and 49-00100-40, Manufactured by Pecan Deluxe Candy Company, 2570 Lone Star Drive, Dallas, TX 75212 Item 07-012-40, Lots 100992, 10209241, 103361, 110381, 11117241, 11117141, 11222231, 11222241, 12030241, 10244241, 10049241, 10099231, and 10244241. Lots of 07-212-40: 102882, 120462, 10162241, 11133231, 120462, 101621, 101622, 10209141, 10209131, 10288131, 10288141, 10288231, 10349241, 10349231, 11133241, 11133231, 11176231, 11176241, 11194231, 11251231, 11251241, 12034231, 120951, 121322, 12182241, 12182132, 12182142, 12182141, 12182131, 12182231, and 12208233. Lots of 49-00100-40: 10133241, 1014715, 10133241, 1023225, 110612, 10133241, 1019625, 103072, and 1116015. Class I The Peanut Butter products were manufactured using peanut butter recalled by Sunland, Inc. for salmonella. Pecan Deluxe Candy Company
Food Peanut Butter Crunch, 45 lb Case, Item Number 01-326-45, Manufactured by Pecan Deluxe Candy Company, 2570 Lone Star Drive, Dallas, TX 75212 Lot #s: 111752, 100781, 101562, 102312, 102662, 103432, 110402, 110401, 113191, and 120971. Class I The Peanut Butter products were manufactured using peanut butter recalled by Sunland, Inc. for salmonella. Pecan Deluxe Candy Company
Food Peanut Butter Fudge Ribbon, 50 lb Pail, Item Number 07-094-50, Manufactured by Pecan Deluxe Candy Company, 2570 Lone Star Drive, Dallas, TX 75212 Lot #s: 112142 Class I The Peanut Butter Ribbon and Chunky Peanut Butter Ribbon were manufactured using peanut butter recalled by Sunland, Inc. for salmonella. Pecan Deluxe Candy Company
Food Chunky Peanut Butter Ribbon, 40 lb Pail, Item Number 07-712-40, Manufactured by Pecan Deluxe Candy Company, 2570 Lone Star Drive, Dallas, TX 75212 Lot Numbers: 10077242, 10077231, 10077241, 101562, 101561, 10196141, 101961, 10196141, 10267231, 10267241, 11089211, 11089221, 11140241, 11140231, 11111231, 11285242, 11285141, 12030241, 12030231, 120871, 121252, 122131, 10085231, 100862, 1005623, 10133242, 10267242, 10267241, 10267231, 10343231, 10343241, 11089221, 11089212, 11089211, 11089221, 11111241, 11111231, 11089212, 111762, 11237231, 11243242, 11243241, 11285242, 11285241, 11237231, 11243242, 12074231, 12073231, 120931, and 121441. Class I The Peanut Butter products were manufactured using peanut butter recalled by Sunland, Inc. for salmonella. Pecan Deluxe Candy Company
Food Peanut Butter Base, 30 lb Pail, Item Numbers 08-010-30, 08-310-30, and 08-810-30, Manufactured by Pecan Deluxe Candy Company, 2570 Lone Star Drive, Dallas, TX 75212 Lot #s: 120462, 11021231, 100122, 10118241, 10118231, 1105412, 110541, 102211, 1032215, 110212, 110542, 10118231, 10118241, 102581, 11140231, 11140242, 11140241, 120462, 10118231, 12034241, 100842, 10111231, 1015515, 110742, 1115425, 112861, 112862, 1103115, 11140242, 11318142, 10111231, 100851, 110212, 11291231, 11291241, 1012525, 103332, and 103471. Class I The Peanut Butter products were manufactured using peanut butter recalled by Sunland, Inc. for salmonella. Pecan Deluxe Candy Company
Food Maple Macadamia Nuts, 25 lb bulk boxes Lot #s 7241, 7242, and 7243 Class I The macadamia nuts have the potential to be contaminated with Salmonella. Nature's Candy, Inc.
Devices Synchron LX System(s) and UniCel DxC 600/800 System(s) Lactate Reagent, Part Number: A95550 Product Usage: Lactate (LACT) reagent, when used in conjunction with Synchron LX System(s), UniCel DxC 600/800 System(s) and Synchron Systems Multi Calibrator, is intended for the quantitative determination of lactate concentration in human plasma and cerebrospinal fluid (CSF). Lot Number: M206209 Class II Beckman Coulter initiated the recall for the Lactate Assay (LACT) Lot M206209 as they received a customer complaint of error message (RXN RATE HI), i.e. no numerical values reported for samples containing Lactate concentration greater than 6.5 mmol/L. Beckman Coulter Inc.
Devices 45 mm Screw, Item #BG7045 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple. Item #BG7045 Class II The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery. Spinal Solutions, LLC
Devices 50 mm Screw, Item #BG7050 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple. Item #BG7050 Class II The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery. Spinal Solutions, LLC
Devices Set Screw, Item #BG3010 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple. Item #BG3010 Class II The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery. Spinal Solutions, LLC
Devices 40 mm Rod, Item #BG1640 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple. Item #BG1640 Class II The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery. Spinal Solutions, LLC
Devices 50 mm Rod, Item #BG1650 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple. Item #BG1650 Class II The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery. Spinal Solutions, LLC
Devices 60 mm Rod, Item #BG1660 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple. Item #BG1660 Class II The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery. Spinal Solutions, LLC
Devices 12mm x 27mm x 8mm 12mm x 27mm x 9mm 12mm x 27mm x 10mm 12mm x 27mm x 11mm 12mm x 27mm x 12mm 12mm x 27mm x 13mm 12mm x 27mm x 14mm Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple. Item # 10227-008 10227-009 10227-010 10227-011 10227-012 10227-013 10227-014 Class II The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery. Spinal Solutions, LLC
Devices 14 x 11 x 6mm 7 deg 14 x 11 x 7mm 7 deg 14 x 11 x 8mm 7 deg 14 x 11 x 9mm 7 deg 14 x 11 x 10mm 7 deg 14 x 11 x 11mm 7 deg 14 x 11 x 12mm 7 deg Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple. Item # 21411-706 21411-707 21411-708 21411-709 21411-710 21411-711 21411-712 Class II The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery. Spinal Solutions, LLC
Devices Copperhead IBFD, Large Neutral, 6mm Copperhead IBFD, Large Neutral, 7mm Copperhead IBFD, Large Neutral, 8mm Copperhead IBFD, Large Neutral, 9mm Copperhead IBFD, Large Neutral, 10mm Copperhead IBFD, Large Neutral, 11mm Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple. Item # C5006 C5007 C5008 C5009 C5010 C5011 Class II The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery. Spinal Solutions, LLC
Devices Fang Screw 20mm Fang Plate 21mm Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple. Item # FP1220 FP1221 Class II The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery. Spinal Solutions, LLC
Devices Femoral component, CR, cemented, #1, left 2103-1310 Femoral component, CR, cemented, #2, left 2103-1320 Femoral component, CR, cemented, #3, left 2103-1330 Femoral component, CR, cemented, #4, left 2103-1340 Femoral component, CR, cemented, #5, left 2103-1350 Femoral component, CR, cemented, #6, left 2103-1360 Femoral component, CR, cemented, #1, right 2103-1410 Femoral component, CR, cemented, #2, right 2103-1420 Femoral component, CR, cemented, #3, right 2103-1430 Femoral component, CR, cemented, #4, right 2103-1440 Femoral component, CR, cemented, #5, right 2103-1450 Femoral component, CR, cemented, #6, right 2103-1460 Femoral component, PS, #1, left 2103-3110 Femoral component, PS, #2, left 2103-3120 Femoral component, PS, #3, left 2103-3130 Femoral component, PS, #4, left 2103-3140 Femoral component, PS, #5, left 2103-3150 Femoral component, PS, #6, left 2103-3160 Femoral component,PS, #1, right 2103-3210 Femoral component,PS, #2, right 2103-3220 Femoral component,PS, #3, right 2103-3230 Femoral component,PS, #4, right 2103-3240 Femoral component,PS, #5, right 2103-3250 Femoral component,PS, #6, right 2103-3260 Variety of hip and knee implants and instruments, multiple uses. Catalog No. 2103-1310 2103-1320 2103-1330 2103-1340 2103-1350 2103-1360 2103-1410 2103-1420 2103-1430 2103-1440 2103-1450 2103-1460 2103-3110 2103-3120 2103-3130 2103-3140 2103-3150 2103-3160 2103-3210 2103-3220 2103-3230 2103-3240 2103-3250 2103-3260 Class II The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery. Orthopedic Alliance LLC
Devices Tibial baseplate,cemented,#1 2203-3010 Tibial baseplate,cemented,#2 2203-3020 Tibial baseplate,cemented,#3 2203-3030 Tibial baseplate,cemented,#4 2203-3040 Tibial baseplate, cemented, #5 2203-3050 Tibial baseplate, cemented, #6 2203-3060 Tibial insert,CR,plained,#1,9mm 2303-1211 Tibial insert,CR,plained,#1,11mm 2303-1212 Tibial insert,CR,plained,#1,13mm 2303-1213 Tibial insert,CR,plained,#1,15mm 2303-1214 Tibial insert,CR,plained,#1,18mm 2303-1215 Tibial insert,CR,plained,#2,9mm 2303-1221 Tibial insert,CR,plained,#2,11mm 2303-1222 Tibial insert,CR,plained,#2,13mm 2303-1223 Tibial insert,CR,plained,#2,15mm 2303-1224 Tibial insert,CR,plained,#2,18mm 2303-1225 Tibial insert,CR,plained,#3,9mm 2303-1231 Tibial insert,CR,plained,#3,11mm 2303-1232 Tibial insert,CR,plained,#3,13mm 2303-1233 Tibial insert,CR,plained,#3,15mm 2303-1234 Tibial insert,CR,plained,#3,18mm 2303-1235 Tibial insert,CR,plained,#4,9mm 2303-1241 Tibial insert,CR,plained,#4,11mm 2303-1242 Tibial insert,CR,plained,#4,13mm 2303-1243 Tibial insert,CR,plained,#4,15mm 2303-1244 Tibial insert,CR,plained,#4,18mm 2303-1245 Tibial insert,CR,plained,#5,9mm 2303-1251 Tibial insert,CR,plained,#5,11mm 2303-1252 Tibial insert,CR,plained,#5,13mm 2303-1253 Tibial insert,CR,plained,#5,15mm 2303-1254 Tibial insert,CR,plained,#5,18mm 2303-1255 Tibial insert,CR,plained,#6,9mm 2303-1261 Tibial insert,CR,plained,#6,11mm 2303-1262 Tibial insert,CR,plained,#6,13mm 2303-1263 Tibial insert,CR,plained,#6,15mm 2303-1264 Tibial insert,CR,plained,#6,18mm 2303-1265 Tibial insert, PS , #1, 9mm 2303-3011 Tibial insert, PS , #1, 11mm 2303-3012 Tibial insert, PS , #1, 13mm 2303-3013 Tibial insert, PS , #1, 15mm 2303-3014 Tibial insert, PS , #1, 18mm 2303-3015 Tibial insert, PS , #2, 9mm 2303-3021 Tibial insert, PS , #2, 11mm 2303-3022 Tibial insert, PS , #2, 13mm 2303-3023 Tibial insert, PS , #2, 15mm 2303-3024 Tibial insert, PS , #2, 18mm 2303-3025 Tibial insert, PS , #3, 9mm 2303-3031 Tibial insert, PS , #3, 11mm 2303-3032 Tibial insert, PS , #3, 13mm 2303-3033 Tibial insert, PS , #3, 15mm 2303-3034 Tibial insert, PS , #3, 18mm 2303-3035 Tibial insert, PS , #4, 9mm 2303-3041 Tibial insert, PS , #4, 11mm 2303-3042 Tibial insert, PS , #4, 13mm 2303-3043 Tibial insert, PS , #4, 15mm 2303-3044 Tibial insert, PS , #4, 18mm 2303-3045 Tibial insert, PS , #5, 9mm 2303-3051 Tibial insert, PS , #5, 11mm 2303-3052 Tibial insert, PS , #5, 13mm 2303-3053 Tibial insert, PS , #5, 15mm 2303-3054 Tibial insert, PS , #5, 18mm 2303-3055 Tibial insert, PS , #6, 9mm 2303-3061 Tibial insert, PS , #6, 11mm 2303-3062 Tibial insert, PS , #6, 13mm 2303-3063 Tibial insert, PS , #6, 15mm 2303-3064 Tibial insert, PS , #6, 18mm 2303-3065 Variety of hip and knee implants and instruments, multiple uses. Catalog No. 2203-3010 2203-3020 2203-3030 2203-3040 2203-3050 2203-3060 2303-1211 2303-1212 2303-1213 2303-1214 2303-1215 2303-1221 2303-1222 2303-1223 2303-1224 2303-1225 2303-1231 2303-1232 2303-1233 2303-1234 2303-1235 2303-1241 2303-1242 2303-1243 2303-1244 2303-1245 2303-1251 2303-1252 2303-1253 2303-1254 2303-1255 2303-1261 2303-1262 2303-1263 2303-1264 2303-1265 2303-3011 2303-3012 2303-3013 2303-3014 2303-3015 2303-3021 2303-3022 2303-3023 2303-3024 2303-3025 2303-3031 2303-3032 2303-3033 2303-3034 2303-3035 2303-3041 2303-3042 2303-3043 2303-3044 2303-3045 2303-3051 2303-3052 2303-3053 2303-3054 2303-3055 2303-3061 2303-3062 2303-3063 2303-3064 2303-3065 Class II The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery. Orthopedic Alliance LLC
Devices UKNEE Patella,small 2401-1010 UKNEE Patella,medium 2401-1020 UKNEE Patella,large 2401-1030 UKNEE Patella,X-large 2401-1040 UKNEE Onset Patella, 3 pegs, x-small 2403-1010 UKNEE Onset Patella, 3 pegs, small 2403-1020 UKNEE Onset Patella, 3 pegs, medium 2403-1030 UKNEE Onset Patella, 3 pegs, large 2403-1040 UKNEE Onset Patella, 3 pegs,X-large 2403-1050 Variety of hip and knee implants and instruments, multiple uses. Catalog No. 2401-1010 2401-1020 2401-1030 2401-1040 2403-1010 2403-1020 2403-1030 2403-1040 2403-1050 Class II The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery. Orthopedic Alliance LLC
Devices U2 Acetabular cup, Ti beads porous coated, È44mm U2 Acetabular cup, Ti beads porous coated, È46mm U2 Acetabular cup, Ti beads porous coated, È48mm U2 Acetabular cup, Ti beads porous coated, È50mm U2 Acetabular cup, Ti beads porous coated, È52mm U2 Acetabular cup, Ti beads porous coated, È54mm U2 Acetabular cup, Ti beads porous coated, È56mm U2 Acetabular cup, Ti beads porous coated, È58mm U2 Acetabular cup, Ti beads porous coated, È60mm U2 Acetabular cup, Ti beads porous coated, È62mm U2 Acetabular cup liner assembly, 10°hooded,44mm U2 Acetabular cup liner assembly, 10°hooded,46mm U2 Acetabular cup liner assembly, 10°hooded,48mm U2 Acetabular cup liner assembly, 10°hooded,50mm U2 Acetabular cup liner assembly, 10°hooded,52mm U2 Acetabular cup liner assembly, 10°hooded,54mm U2 Acetabular cup liner assembly, 10°hooded,56mm U2 Acetabular cup liner assembly, 10°hooded,58mm U2 Acetabular cup liner assembly, 10°hooded,60mm U2 Acetabular cup liner assembly, 10°hooded,62mm Variety of hip and knee implants and instruments, multiple uses. Item No. 1303-5444 1303-5446 1303-5448 1303-5450 1303-5452 1303-5454 1303-5456 1303-5458 1303-5460 1303-5462 1403-1044 1403-1046 1403-1048 1403-1250 1403-1252 1403-1654 1403-1656 1403-1658 1403-1660 1403-1662 Class II The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery. Orthopedic Alliance LLC
Devices Femoral head, standard, Æ26mm, +0mm Femoral head,medium, Æ26mm,+3mm Femoral head, long, Æ26mm, +6mm Femoral head, X-long, Æ26mm, +9mm Femoral head, Æ28mm, -3mm Femoral head, Æ28mm, +0mm Femoral head, Æ28mm, +5mm Femoral head, Æ28mm, +10mm Femoral head, Æ32mm, -3mm Femoral head, Æ32mm, +0mm Femoral head, Æ32mm, +5mm Femoral head, Æ32mm, +10mm Femoral head, Æ36mm, -3mm Femoral head, Æ36mm, +0mm Femoral head, Æ36mm, +5mm Femoral head, Æ36mm, +10mm Variety of hip and knee implants and instruments, multiple uses. Item No. 1201-1126 1201-1326 1201-1526 1201-1726 1201-1028 1201-1128 1201-1428 1201-1828 1201-1032 1201-1132 1201-1432 1201-1832 1201-1036 1201-1136 1201-1436 1201-1836 Class II The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery. Orthopedic Alliance LLC
Devices Bipolar Cap, ID26mm, OD42mm Bipolar Cap, ID28mm, OD44mm Bipolar Cap, ID28mm, OD46mm Bipolar Cap, ID28mm, OD48mm Bipolar Cap, ID28mm, OD50mm Bipolar Cap, ID28mm, OD52mm Bipolar Cap, ID28mm, OD54mm Bipolar Cap, ID28mm, OD56mm Item No. 1503-3042 1503-3144 1503-3146 1503-3148 1503-3150 1503-3152 1503-3154 1503-3156 Class II The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery. Orthopedic Alliance LLC
Devices Co-Cr cancellous bone screw,15mm Co-Cr cancellous bone screw,20mm Co-Cr cancellous bone screw,25mm Co-Cr cancellous bone screw,30mm Co-Cr cancellous bone screw,35mm Co-Cr cancellous bone screw,40mm Variety of hip and knee implants and instruments, multiple uses. Item No. 5201-6715 5201-6720 5201-6725 5201-6730 5201-6735 5201-6740 Class II The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery. Orthopedic Alliance LLC
Devices Zweimueller Type Stem SCS-Standard Sz 01 Zweimueller Type Stem SCS-Standard Sz 00 Zweimueller Type Stem SCS-Standard Sz 1 Zweimueller Type Stem SCS-Standard Sz 2 Zweimueller Type Stem SCS-Standard Sz 3 Zweimueller Type Stem SCS-Standard Sz 4 Zweimueller Type Stem SCS-Standard Sz 5 Zweimueller Type Stem SCS-Standard Sz 6 Zweimueller Type Stem SCS-Standard Sz 7 Zweimueller Type Stem SCS-Standard Sz 8 Zweimueller Type Stem SCS-Standard Sz 9 Zweimueller Type Stem SCS-Standard Sz 10 Zweimueller Type Stem SCL-Lateralized Sz 3 Zweimueller Type Stem SCL-Lateralized Sz 4 Zweimueller Type Stem SCL-Lateralized Sz 5 Zweimueller Type Stem SCL-Lateralized Sz 6 Zweimueller Type Stem SCL-Lateralized Sz 7 Zweimueller Type Stem SCL-Lateralized Sz 8 Zweimueller Type Stem SCL-Lateralized Sz 9 Zweimueller Type Stem SCR-Revision Sz 3 Zweimueller Type Stem SCR-Revision Sz 4 Zweimueller Type Stem SCR-Revision Sz 5 Zweimueller Type Stem SCR-Revision Sz 6 Zweimueller Type Stem SCR-Revision Sz 7 Zweimueller Type Stem SCR-Revision Sz 8 Zweimueller Type Stem SCR-Revision Sz 9 Zweimueller Type Stem SCR-Revision Sz 10 Zweimueller Type Stem SCR-Revision Sz 11 Variety of hip and knee implants and instruments, multiple uses. Part No. 120.00.15 120.00.00 120.00.01 120.00.02 120.00.03 120.00.04 120.00.05 120.00.06 120.00.07 120.00.08 120.00.09 120.00.10 123.00.03 123.00.04 123.00.05 123.00.06 123.00.07 123.00.08 123.00.09 126.00.03 126.00.04 126.00.05 126.00.06 126.00.07 126.00.08 126.00.09 126.00.10 126.00.11 Class II The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery. Orthopedic Alliance LLC
Devices Ball Head, 28 Short CERAMIC Ball Head, 28 Medium CERAMIC Ball Head, 28 Long CERAMIC Ball Head, 32 Short CERAMIC Ball Head, 32 Medium CERAMIC Ball Head, 32 Long CERAMIC Ball Head, 28 Short CoCr Ball Head, 28 Medium CoCr Ball Head, 28 Long CoCr Ball Head, 28 X-Long CoCr Ball Head, 28 XX-Long CoCr Ball Head, 32 Short Ball Head, 32 Medium Ball Head, 32 Long Part No. 194.01.28 194.02.28 194.03.28 195.01.32 195.02.32 195.03.32 188.01.28 188.02.28 188.03.28 188.04.28 188.05.28 189.01.32 189.02.32 189.03.32 Class II The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery. Orthopedic Alliance LLC
Drugs Seasonale(R) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg, 3 extended-cycle tablet dispensers, 91 tablets each, Rx only, TEVA Women Health, Inc., Subsidiary of TEVA Pharmaceuticals USA, Inc., Sellersville, PA NDC 51285-058-66 NDC 51285-058-66 -- lot numbers 33802330A, exp 6/2013; and 33802464A, exp 6/2013. Class III Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing Teva Pharmaceuticals USA, Inc.
Drugs Camrese(TM) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg and Ethinyl Estradiol 0.01 Tablets, 2 Extended-Cycle Tablet Dispensers (NDC 0093-3134-82) and 1 Extended-Cycle Tablet Dispenser NDC 0093-3134-91), 91 Tablets Each, Rx only, TEVA Womens Health Inc., Subsidiary of TEVA Pharmaceuticals, Inc., Sellersville, PA NDC 0555-3134-82 and 0093-3134-91 -- lot numbers 33802566A, exp 3/2013; 33802967A, exp 8/2013; 33803529A, exp 10/2013; and 33803609A, exp 11/2013. Class III Failed Impurity/Degradation Specifications; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing Teva Pharmaceuticals USA, Inc.
Biologics Red Blood Cells W036809153837; Class II Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells Leukocytes Reduced W087909308200; Class II Blood product, which was collected from a donor who traveled to malarial endemic areas, was distributed. Community Blood Bank of Lancaster County Medical Society
Biologics Red Blood Cells W038112323158; W038112238855; W038112187650 Class II Blood products, which were collected from a donor who traveled to malarial endemic areas, were distributed. Florida's Blood Centers, Inc.
Biologics Red Blood Cells Leukocytes Reduced W125612431026 Class II Blood products, collected from a donor with a history of Hepatitis A, were distributed. Blood Bank Of San Bernardino And Riverside Counties
Biologics Blood and Blood Products for Reprocessing W125612431026 Class II Blood products, collected from a donor with a history of Hepatitis A, were distributed. Blood Bank Of San Bernardino And Riverside Counties
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W227013005262; Class II Blood products, which did not meet the acceptable product specifications, were distributed. Community Blood Center of Carolinas
Biologics Platelets Pheresis Leukocytes Reduced W227013005262; W227013005262; Class II Blood products, which did not meet the acceptable product specifications, were distributed. Community Blood Center of Carolinas
Devices ***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone. Lots numbers: D433040800, D403040236, D383039472. Class II Due to three batches of product may have diamond grit size larger than intended applied to the head of the cutting burr. The Anspach Effort, Inc.
Drugs Camila 0.35 mg Tablets, 6 cards of 28 pills, Dist. By: Physicians Total Care, Tulsa, OK --- NDC 54868-4814-0, MFG By TEVA Pharmaceuticals USA, Sellersville, PA Physicians Total Care Lots: 6Z4C Exp. 10/31/2013 Class III Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing Physicians Total Care, Inc.
Food 7th Heaven Bakeries Oatmeal Raisin Cookie, 7th Heaven Bakeries, Oklahoma City, OK Best By Dates prior to 05/07/13. Class I Undeclared egg, soy and milk. 7-Eleven Stores of Oklahoma
Drugs Ropinirole hydrochloride tablets, USP 4 mg, 100-count bottle (NDC 0378-5504-01), Rx only, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. Made in India Lot # ZRMB11004, Exp 09/13 Class II Labeling: Label Error on Declared Strength- Unopened bottles of Ropinirole USP 3 mg tablets was found to be incorrectly labeled as Ropinirole USP 4 mg tablets.. Mylan Pharmaceuticals Inc.
Drugs Bimix Inj 30 :1 Syr, 12x1.5 ml syr, 10x1.2 ml syr, 2x2 ml syr, 2x1 ml syr, 12x.05 ml syr Penile Injection,30 and 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc.
Drugs Bimix Inj 30:0.5 MDV, 5 ml syr Penile Injection, 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc.
Drugs Bimix Inj 30:1 MDV: 5ml, 10 ml, 3x10ml, 2x10ml Penile Injection, 30 and 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc.
Drugs Papaverine Inj 30mg/ml Syr, 5mlsyr, 10mlsyr,10x0.95mlsyr Penile Injection, 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc.
Drugs PGE-1 Inj 10mcg/ml MDV, 5ml Penile Injection, 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc.
Drugs PGE-1 Inj 20mcg/ml MDV: 5ml, 7ml, 10ml, 20ml Penile Injection, 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc.
Drugs PGE-1 Inj 30mcg/ml MDV, 7 ml Penile Injection, 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc.
Drugs PGE-1 Inj 40mcg/ml MDV, 5 ml Penile Injection, 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc.
Drugs Trimix Inj 30:1:10 MDV, 5 ml Penile Injection, 30 and 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc.
Drugs Trimix Inj 30:1:20 MDV: 5 ml, 10 ml, 2x5 ml Penile Injection, 30 and 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc.
Drugs Trimix Inj 30:1:40 MDV, 5 ml Penile Injection, 30 and 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc.
Drugs Trimix Inj 30:3:5 MDV, 10ml Penile Injection, 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc.
Drugs Trimix Inj 4.25ml Form MDV Penile Injection, 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc.
Drugs Super Trimix #1 Inj MDV, 12 ml Penile Injection, 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc.
Drugs Vancomycin Opth Soln 25mg/ml PF, 10ml Opthalmic Soln, 10 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc.
Drugs Vancomycin Opth Soln 30mg/ml PRES, 10ml Opthalmic Soln, 30 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc.
Drugs Vancomycin Opth Soln14mg/ml PF, 10ml Opthalmic Soln, 30 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc.
Drugs Tobramycin Opth Soln 14mg/ml, 7ml Opthalmic Soln, 10 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc.
Drugs Tobramycin Opth Soln 13mg/ml, 7ml Opthalmic Soln, 10 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc.
Drugs Chlorhexidine Opth Soln 0.02%, 10 ml Opthalmic Soln, 30 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc.
Drugs Dexamethasone Opth Soln 0.1% PF, 10 ml Opthalmic Soln, 30 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc.
Drugs PHMB Opth Soln 0.02%, 10 ml Opthalmic Soln, 30 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc.
Drugs Folic Acid Inj 5mg/ml MDV, 10 ml Subcutaneous, 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc.
Drugs HCG Inj 1000un/ml MDV: 4ml, 8 ml Subcutaneous, 30 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc.
Drugs HCG Inj 1200un/ml MDV, 10 ml Subcutaneous, 30 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc.
Drugs HCG Inj 1250 un/ml MDV, 4 ml Subcutaneous, 30 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc.
Drugs HCG Inj 500un/ml MDV, 5 ml Subcutaneous, 30 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc.
Drugs Hydroxycobalamin Inj 1000mcg/ml MDV: 10 ml, 15 ml, 20 ml, 30 ml Subcutaneous, 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc.
Drugs Hydroxycobalamin Inj 1 mcg/ml MDV, 2x30ml Subcutaneous, 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc.
Drugs Hydroxycobalamin Inj 2500 mcg/ml MDV, 2x30ml Subcutaneous, 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc.
Drugs Methylcobalamin Inj 1mg/ml MDV, 10 ml, 15 ml, 20 ml, 30 ml, 4x30 ml Subcutaneous, 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc.
Drugs Methylcobalamin Inj 5mg/ml MDV: 5 ml, 10 ml, 12 ml, 20 ml Subcutaneous, 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc.
Drugs Methylcobalamin 5mg/ml Inj Syr, 10x0.4syr Subcutaneous, 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc.
Drugs Methylcobalamin Inj 2.5mg/ml MDV, 10 ml Subcutaneous, 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc.
Drugs Methylcobalamin Inj 25mg/ml Syr: 8x0.06mlsyr, 10x0.06 ml syr, 12x0.06 ml syr Subcutaneous, 30 and 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc.
Drugs Hydroxyprogesterone Inj 250mg/ml MDV, 5 ml Intramuscular, 30 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc.
Drugs Renacidin Irrigation: 1000 ml,1120ml Bladder Irrigation, 30 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc.
Drugs Gentamicin 24mg/60ml Irrigation, 15x60ml Syr Irrigation, 14 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc.
Drugs Glutathione 200mg/ml Inj SDV: 3x50ml 14 day expiration, 1x50ml 21 day expiration All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc.
Drugs M.I.C.+B12 Inj MDV: 3x50ml, 4x50 ml 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc.
Drugs Lidocaine 2% Inj MDV, 20 ml 30 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc.
Drugs Meperidine 100mg/ml MDV, 5ml 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc.
Drugs Pyridoxine 100mg/ml Inj MDV, 1X30 ml 30 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc.
Devices QuietCare-Networked. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community. QuietCare-Networked: Facility Server QC101601 Class II Customers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product. Intel-GE Care Innovations LLC
Devices QuietCare. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community. US  QuietCare: QC200403, v.02; QC200403, v.03; QC200403, v.04; QC200405 UK  QuietCare: QCE200403, v.02; QCE200403, v.03 Class II Customers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product. Intel-GE Care Innovations LLC
Devices NEXGEN Complete Knee Solution Monoblock Tibial Drill with stop 10.7 mm. Used to prepare cylindrical holes in the native tibia. Part No. 00-5887-052-00; lots 62181290 and 62183430 Class II Zimmer is initiating a lot specific recall of the Trabecular Metal" Tibia Stop Drill due to the potential of the outside diameter being oversized. As a result, there is a potential for the drill to not pass through the applicable drill guide. Zimmer, Inc.
Devices Alere" hCG Combo Cassette (20/10 mIU/mL) Kit. Product Usage: The AlereTM hCG Combo (20/10 mIU/mL) test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine, as an aid in the early detection of pregnancy. It is for healthcare professionals only. Lot/Unit Codes: hCG1110133 & hCG1110135 Part Number: 92215 Expiration date, or Expected shelf life: 9/30/13 & 10/31/13 Class II The firm initiated recall of Alere" hCG Combo Cassette (20/10 mIU/mL) kit PN 92215, lots hCG1110133 and hCG1110135, because an investigation has indicated a portion of these Alere" hCG Combo Cassette (20/10 mIU/mL) PN 92215 kit lots were incorrectly packaged with the Alere" hCG Cassette (20 mIU/mL) PN 92210 Product Insert. The Alere" hCG Cassette (20 mIU/mL) Product Insert contains information for hCG urine testing but lacks information for performing the hCG serum testing using the Alere" hCG Combo Cassette product. Alere San Diego, Inc.
Devices Integrity 3.0 Product Usage: The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed. 325134, 325254, 325082, 325159, 325268, 325237, 325331, 325267, 325236, 325314, 325127, 325261, 325286, 325077, 325269, 325129, 325296, 325273, 325139, 325201, 325137, 325184, 325161, 325076, 325086, 325112, 325081, 325083, 325099, 325110, 325271 Class II Unexpected movement during beam delivery may not be detected if there are incorrect static tolerances for Linac Geometric Axes loaded in Integrity R3.0. Elekta, Inc.
Devices PTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers Product Usage: used by healthcare professionals and individuals with diabetes to measure glucose in whole blood U1117 Class II Internal investigation demonstrated under-recovery for glucose when tested against a reference method. This could result in a low to moderate health risk. Polymer Technology Systems, Inc.
Devices EZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medications for respiratory usage. Model # EZ-100 Lots # R2029A, R2029B, R2039A, R2042A, R2045A, and R2047A. Atomizer Serial Number Ranges: 1206034476-1206069065 1207003710-1237038299 1207046505-1207081124 1208027421-1208062155 1209000001-1209069179 1209069180-1209069202 1209069203-1209069460 1210000001-1210103680 1210104001-1210104044 Class I Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard. Nephron Pharmaceuticals Corp.
Devices Asthmanefrin Starter Kit contains ten (10) Asthmanefrin vials and one (1) EZ Breathe Atomizer. For the delivery of liquid medications for respiratory usage. Lots # R2029A, R2029B, R2039A, R2042A, R2045A, and R2047A. Atomizer Serial Number Ranges: 1206034476-1206069065 1207003710-1237038299 1207046505-1207081124 1208027421-1208062155 1209000001-1209069179 1209069180-1209069202 1209069203-1209069460 1210000001-1210103680 1210104001-1210104044 Class I Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard. Nephron Pharmaceuticals Corp.
Devices EZ Breathe Medication Cup. For the delivery of liquid medications for respiratory usage. Lots #120902, Lot # 120903 and Lot # 120904 Class I Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard. Nephron Pharmaceuticals Corp.
Drugs Lisinopril Tablets, USP, 30 mg, Rx only, 100 tablets, NDC 65862-041-01 Manufactured for: Aurobindo Pharma USA Inc. 2400 Route 130 North, Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyderabad- 500 072 India Lot KP3012001-A Exp.12/13 Lot KP3012002-A Exp.12/13 Class III Labeling: Label Error on Declared Strength: Incorrect strength on side display panel of label Aurobindo Pharma USA Inc
Devices Thyroidectomy Indication for the da Vinci Surgical Systems; Product Usage: da Vinci Thyroidectomy offers a minimally invasive surgery for both partial and total thyroidectomy procedures, including endoscopic and video assisted procedure that are preferable to conventional (open) procedures that utilize a cervical incision because they leave no visible neck scar. NA - marketing and promotional only. Class II Promotional literature for use of the da Vinci system for thyroidectomy, which had not been approved with a change to the 510(k). Intuitive Surgical, Inc.
Devices Tip Cover Accessory, 8 MM, MCS, box of 10 Product Usage: The disposable Tip cover accessory is used in conjunction with the 8mm Monopolar Curved Scissors Instruments to cut and coagulate tissue. The tip cover is intended to provide electrical insulation over a section of the Monopolar Curved Scissors instrument so that FR energy is only available at the scissors blades. Model numbers: 400180-10 and prior versions 400180-01, 400180-02, 400180-03, 400180-04, 400180-05, 400180-05, 400180-06. 400180-07, 400180-08 and 400180-09. Class II Clarification of existing labeling and related cautions for the tip cover accessory of the da Vinci Surgical System. Intuitive Surgical, Inc.
Food Meijer Diced Pears in Fruit Juice 8oz cup UPC: 71373337044 and All lots produced from November 29, 2012 through January 2, 2013. Class III Meijer Diced Pears in Fruit Juice, Meijer Diced Peaches in Fruit Juice, and Meijer Mandarin Oranges in Fruit Juice 8 oz (226g) labels were developed, the Serving Size was updated to 1 cup (226g) but the nutrition facts still reflect the 4 oz (113g) information. Meijer Distribution, Inc
Food Meijer Diced Peaches in Fruit Juice 8oz cup UPC: 71373337017 and All lots produced from November 29, 2012 through January 2, 2013. Class III Meijer Diced Pears in Fruit Juice, Meijer Diced Peaches in Fruit Juice, and Meijer Mandarin Oranges in Fruit Juice 8 oz (226g) labels were developed, the Serving Size was updated to 1 cup (226g) but the nutrition facts still reflect the 4 oz (113g) information. Meijer Distribution, Inc
Food Meijer Mandarin Oranges in Fruit Juice 8oz cup UPC: 88692601216 and All lots produced from November 29, 2012 through January 2, 2013. Class III Meijer Diced Pears in Fruit Juice, Meijer Diced Peaches in Fruit Juice, and Meijer Mandarin Oranges in Fruit Juice 8 oz (226g) labels were developed, the Serving Size was updated to 1 cup (226g) but the nutrition facts still reflect the 4 oz (113g) information. Meijer Distribution, Inc
Devices Canon Full Auto Ref-Keratometer RK-F2, Catalog Number 6937B002AA. Product Usage: This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye. Catalog Number 6937B002AA. All serial numbers from the first unit onward. Class II Canon Inc. had received 17 claims from our foreign sales companies between October to November 2012 that measurement value of RK-F2s refractive power (SPH value) sometimes indicated abnormal value which occurs approximately 5% in probability. Canon Inc.
Devices Cannula 8MM Regular. Provides the means of introduction and placement of an instrument or accessory into the human body. Model number 420002-07 Class II Clarification of existing labeling information and operating procedures. Intuitive Surgical, Inc.
Devices Flush Port (used in almost all da Vinci instruments) Assists in cleaning the instrument. Model numbers: 340066-07 - straight; 340234-02 - extended taper; 340241-03 - 5mm; 340584-01 - Gemini 8mm straight; 340586-02 - Gemini 5mm; 340725-01 - Vespa straight; 340800-01 - Gemini ext taper; 340971-01 - IS1200 Grasping 340972-01 IS2000 Grasping. Class II Clarification of existing labeling information and operating procedures. Intuitive Surgical, Inc.
Devices da Vinci Si Surgeon Console. Intended to assist in the accurate Control of Intuitive Surgical Endoscopic Instruments. Model number: 314850, versions 1-6 Class II Clarification of existing labeling information and operating procedures. Intuitive Surgical, Inc.
Devices Heart Sync C100-Physio Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible pacing/ cardioversion Defibrillation /ECG Monitoring electrodes Used in connection with a defibrillator to deliver an electrical current (shock) to the patient's heart during cardiac emergencies. Part number : C100-Physio and Lot numbers: Y100112-02, Y102212-03, Y121312-18, Y012413-02, Y022013-01, Y032113-01 Class II On 4/18/13 HEARTSYNC became aware of a recall from their wire/connector sub-assembly supplier which is used in the C100-Physio Electrodes. There were reports of equipment damage due to misalignment from tooling installed in August 2012. The result of this damage could render the device incapable of delivering the appropriate energy or shock to the patient. Heart Sync, Inc
Devices Vermed, Inc Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible defibrillation/cardioversion/pacing/ECG Monitoring electrodes. Used in connection with a defibrillator to deliver an electrical current (shock) to the patient's heart during cardiac emergencies. Part Number: D304 and lot numbers:Y100112-02, Y102212-03, Y121312-18, Y012413-02, Y022013-01, Y032113-01 Class II On 4/18/13 HEARTSYNC became aware of a recall from their wire/connector sub-assembly supplier which is used in the C100-Physio Electrodes. There were reports of equipment damage due to misalignment from tooling installed in August 2012. The result of this damage could render the device incapable of delivering the appropriate energy or shock to the patient. Heart Sync, Inc
Devices BBL DrySlide PYR Kit, catalog number 231747 Product Usage: Presumptive diagnostic aid for group A streptococci and group D enterococci bacteria. PYR kit - lot 2276481 with expiration date 09/30/13 Class II In-vitro diagnostic agents were placed into incorrect packaging for distribution to microbiological laboratories. Becton Dickinson & Co.
Devices BBL DrySlide Oxidase Kit, catalog number 231746 Product Usage: Presumptive diagnostic aid for gram-negative bacteria. Oxidase kit - lot 2222008 with expiration date 08/31/13 Class II In-vitro diagnostic agents were placed into incorrect packaging for distribution to microbiological laboratories. Becton Dickinson & Co.
Devices User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000. Product Usage: The user manual for Transoral Surgery (TORS) provided information to update and replace the Indications for Use and Representative uses section and add the section Warnings for Transoral Otolaryngology Surgery. Model number 552002-01 Class II Change to User Manual to remove one indication for use and amend warnings to emphasize restrictions for use. Intuitive Surgical, Inc.
Food Red Bone Alley Restaurant Wasabi All Natural Sauce for all Seafood & Chicken, Net Wt. 12 fl oz. Distributed by: Red Bone Alley Foods, LLC, 1903 W. Palmetto Street, Florence, SC 29501. Clear Plastic (Pet) Ring Neck Round bottle with neck band with white screw top cap. 6/12oz bottles= 1 case. Lot Codes 060213, 0611130003, 072713007, 122713006, 012114001, and 040514003 Class III Undeclared metabisulfite National Food & Beverage, Inc
Devices AU2700 Clinical Chemistry Analyzer AU5400 Clinical Chemistry Analyzer Perform automated analysis of serum, urine, and other body fluids, including whole blood. All Serial Numbers Model Numbers: AU2700, AU27000ISE, AU5421, AU5421ISE, AU5431. Part Numbers: E0750053 N3663400 N3663700 N3664000 N3664200 N3664400 N3664600 N3664800 N3878500 1465600 64270G E61DAU2700 N3663500 N3663600 N3663800 N3663900 N3664100 N3664300 N3664500 N3664700 N3664900 N3878600 O9102700 N3665000 N3665100 N3665200 N3665300 N3665400 N3878300 64542 A94504 N1683100 AU5431-U1 N3665500 N3665600 N3665700 N3665800 N3665900 N3878400 Class II Beckman Coulter is recalling AU2700/AU2700 Plus & AU5400 Clinical Chemistry Analyzers becuase it was determined that the tubing/joint connections associated with these MODs may leak concentrated detergent. Beckman Coulter has received complaints that the joint connecting the tubing appears to disintegrate over time, causing a leak. Beckman Coulter Inc.
Devices AngioDynamics Micro Introducer Kits under the following labeling: 1) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597005, 2) AngioDynamics 5F Standard Micro-Introducer Kit, Sterile, Catalog number: 06597012; 3) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597013; 4) AngioDynamics 5F Standard Micro- Introducer Kit, Sterile, Catalog Number: 06597018; and 5) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597019. Product kits are individually wrapped in plastic, 10 units included per box. Product Usage: This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye. Corresponding Lot numbers: 1) 588918 (Expiration date 01/2016), 2) 588927 (Expiration date 12/2015), 3) 588915 (Expiration date 01/2016), 4) 588913 (Expiration date 12/2015) and 5) 588930 (Expiration date 01/2016). Class II AngioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kits, because the potential exists that the micro Introducer (sheath/dilator) packaged within the kit could be the incorrect French size. Angiodynamics, Inc.
Devices AngioDynamics VenaCure EVLT NeverTouch-FRS PROCEDURE KIT under the following labeling: 1) Gold-Tipped Fiber 45cm Kit, Catalog Number: 11403301; 2) Gold-Tipped Fiber 65cm Kit, Catalog Number: 11403302; 3) Gold-Tipped Fiber 90cm Kit, Catalog Number: 11403304. Product Usage: This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye. Corresponding Lot numbers: 1) 588948, 2) 588495 and 3)588480. Expiration date for these lot numbers: 12/2013. Class II AngioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kits, because the potential exists that the micro Introducer (sheath/dilator) packaged within the kit could be the wrong French size. Angiodynamics, Inc.
Devices adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes, Model P-211-M1 and P-214-M1. Product Usage: Used by trained professionals in hospitals, doctors offices, and Emergency Medical Services for adult low-energy defibrillation, transcutaneous pacing, cardioversion and monitoring. Model P-211-M1 Lot numbers: Y081712-17; Y081712-18; Y081712-19; Y081712-20; Y112612-08; Y112612-09; Y112612-10; Y112612-11; Y112612-12; Y112612-13; and Y020113-07. Model P-214-M1 Lot numbers: Y081712-04; Y112612-24; Y112612-23; and Y031913-10. Class II TZ Medical Inc is recalling its P-211-M1 and P-214-M1 Medtronic / Physio Control Compatible transparent defibrillation electrodes because it may contain a defective white wire on the connector assembly. If a failure were to occur, the end user would be able to identify the failure by inspecting the white wire 1/4 inch from the Gray Medtronic / Physio adapter. The consignees will notice discoloration in the protective plastic jacket. TZ Medical Inc.
Food Talenti Roman Raspberry Sorbetto, 16fl oz, Crafted by Talenti, Marietta, GA 30062 UPC 1 86852 00082 2, Lot #10/19/2014 M2 Class II Undeclared Allergen, Pecans Talenti Gelato
Devices RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICATION NAME: System, Planning, Radiation Therapy Treatment. RayStation is a software system designed for treatment planning and analysis of radiation therapy. Software version and build numbers 2.0.0.15, 2.5.1.89, and 3.0.0.251 (to determine if the version used is affected, bring up the About box in the RayStation application and check the build number reported0. Class II Under some circumstances, imported CT, MR and PET images are offset from their true positions by one pixel in one or two directions. Users must be aware of this information to avoid incorrect dose calculations during treatment planning. RAYSEARCH LABORATORIES AB
Devices Merit Medical PerfOrma Anglographic Catheter 5F Multipack Product Usage: Angiographic catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures. Lot Numbers: 1662386, 1662390, 1662385, 1662387, 1662391 Class II Merit Medical Systems is recalling various lots of Performa Cardiac Multipacks containing a JR4.0 catheter due to a slight variation in tip shape. Merit Medical Systems, Inc.
Devices Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide correction, immobilization and stabilization of spinal segments. 83010 85001 85002 83005-30 83005-35 83005-40 83005-45 83005-50 83006-30 83006-35 83006-40 83006-45 83006-50 83006-55 83006-60 83007-30 83007-35 83007-40 83007-45 83007-50 83007-55 83008-30 83008-35 83008-40 83008-45 83008-50 83008-55 83008-80 82001-1 Catalog Numbers: LA-HSS0010 LA-HDOO01 LA-CTOO02 LA-PS0530 LA-PS0535 LA-PS0540 LA-PS0545 LA-PS0550 LA-PS0630 LA-PS0635 LA-PS0640 LA-PS0645 LA-PS0650 LA-PS0655 LA-PS0660 LA-PS0730 LA-PS0735 LA-PS0740 LA-PS0745 LA-PS0750 LA-PS0755 LA-PS0830 LA-PS0835 LA-PS0840 LA-PS0845 LA-PS0850 LA-PS0855 LA-PS0880 LA-SOO01 Lots Affected: All Class II Alphatec Spine initiated this medical device recall for the following reason: due to tolerancing, the flange of the Phygen Leucadia" Autolok set screw may interfere with the top of the screw head prior to fully locking the rod. If this condition occurs, the polyaxial screw head and rod may fail to provide a rigid construct under loading. To date there have been no reports of patient injury, adverse events or complaints received for this issue. Alphatec Spine, Inc.
Devices Natus neurology Dantec KEYPOINT.NET 2.20. Catalog/Part Numbers: 9031A070103, 9031A006502, 9033A071103, 9033A072102, 9031A070102, 9033A007402, 9033A071102, 9033A072103, 9033A0701, 9033A0711HA, 9033A071101, 9031A070101, 9031A006401, 9031A006501, 9033A004701, 9031A0032, 9033A0517, 9033A072101, 9031A0031, 9031A0701BV, 9033A0044, 9033A0073AA, 9031A0063, 9033A0523, 9033A071143, 9033A072143, 9031A006406, 9031A006506, 9031A070106, 9033A004606 9033A004706, 9033A007406, 9033A0537, 9033A0544, 9033A071106, 9033A072106, 9033A0524, 9033A0711BV, 9033A007401, 9033A0516, 9031A006403, 9031A006503, 9033A056403, 9033A0721BV, 9031A006402, 9031A006405, 9031A051306, 9031A070105, 9033A0072, 9033A007301, 9033A0711AA, 9033A0721AA Product Usage: Dantec KEYPOINT.NET Software 2.20 is installed on the Keypoint EMG System which is intended as an electro-physiological aid to assess diagnosis and prognosis and to monitor diseases of the central and peripheral nervous system. It can also be used to study functional aspects of nerves and muscles. SERIAL NUMBERS: 30317 22029 36079 36063 35182 36070 21963 21964 30068 30240 30170 22083 22085 30285 30286 30288 30323 30192 30214 30207 30325 30106 30168 21971 21972 30075 30212 21760 2717 30293 30365 36002 30193 36121 21962 36124 30364 35089 30045 35101 36090 21677 30362 35244 35209 36091 35297 36089 35032 35304 30167 30290 30110 30111 36012 30382 30410 30411 30412 30419 36107 36113 30407 35245 35293 35312 35181 35254 30315 30318 30384 35178 35173 35144 36186 36178 36199 2730 36125 36123 36132 30380 30428 20945 21249 21398 21580 21892 22120 30149 4268 20661 20704 20646 4140 4035 35190 30314 30328 30313 30327 30348 30401 30400 20322 21278 21272 21273 21678 21898 21747 21750 21823 21983 21741 21662 21989 22185 21821 22018 22017 22027 21826 21656 30124 30128 30130 30122 30032 30267 30268 30084 30022 30257 3637 4012 1956 20742 20737 20878 21581 21586 21587 20876 21110 21111 21156 21275 21281 21282 21283 21401 2363 35162 35163 35168 35170 35151 35024 35183 30349 36167 36168 36170 36171 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35141 35166 35092 35191 35192 36011 36007 36094 36138 Class II Alpine Biomed ApS is recalling Natus neurology Dantec KEYPOINT.NET ver. 2.20 Software due to the presence of a software bug. Alpine Biomed Aps
Devices 8mm Precise Bipolar Forceps used in conjunction with the da Vinci S Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments. Model number: 400110-10; Lot numbers: M10120807 M10120817 M10120831 M10120910 M10121008 M10121012 M10121024 M10121115 M10121123 M10121130 M10121206 M10121210 M10130124 M10130131 M10130205 M10130304 M10130319 M10130321 Class II Reports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser, preventing a bipolar cautery cable from being properly connected which results in loss of cautery function of Bipolar Instruments. Intuitive Surgical, Inc.
Devices 8mm Maryland Bipolar Forceps used in conjunction with the da Vinci S Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments. Model number: 400172-08; Lot numbers: M10120815 M10120817 M10120831 M10120913 M10120918 M10121008 M10121024 M10121120 M10121123 M10121203 M10121210 M10121215 M10130220 M10130222 M10130311 M10130315 M10130327 M10130411. Class II Reports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser, preventing a bipolar cautery cable from being properly connected which results in loss of cautery function of Bipolar Instruments. Intuitive Surgical, Inc.
Devices 8mm Fenestrated Bipolar Forceps used in conjunction with the da Vinci S Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments. Model number: 400205-04; Lot numbers: M10120816 M10120820 M10120903 M10120910 M10120912 M10120921 M10121008 M10121024 M10121120 M10121130 M10121206 M10121213 M10121215 M10130124 M10130131 M10130213 M10130218 M10130222 M10130313 M10130319 M10130402. Class II Reports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser, preventing a bipolar cautery cable from being properly connected which results in loss of cautery function of Bipolar Instruments. Intuitive Surgical, Inc.
Food next by Nature brand DARK CHOCOLATE BANANAS, NET WT. 3 Oz. (85g), UPC 8 17582 25600 4, Produced by Tropical Valley Foods "Best by Date" of 12/18/2013 and 12/19/2013 Class I The product contains the undeclared allergens walnuts and milk. Tropical Valley Foods, Inc.
Food GRATED 2/25 GRANA PADANO; Lot Code: 313701A01; Pack Size: 2/25#; Net Pounds: 50; PACK DATE: 05/18/13; ITEM#DGP03; arthur schuman inc, 40 new dutch lane fairfield nj 07004 U.S.A.; 937-227-0030 www.arthurschuman.com; Product Code: ARG07146JP; Lot No.: 311501A01 Class I Grated Grana Padano Hard Italian Cheese was tested and found to be positive for Listeria monocytogenes. Arthur Schuman Midwest LLC
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