Enforcement Report - Week of February 27, 2013
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| Product Type | Product Description | Code Info | Classification | Reason for Recall | Recalling Firm |
|---|---|---|---|---|---|
| Biologics | Cryoprecipitated AHF | J65110 | Class II | Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. | Mississippi Valley Reg Bld Ctr |
| Biologics | Fresh Frozen Plasma | J62864 | Class II | Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. | Mississippi Valley Reg Bld Ctr |
| Biologics | Recovered Plasma | J65110 | Class II | Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. | Mississippi Valley Reg Bld Ctr |
| Biologics | Cryoprecipitated AHF | 1933200 | Class II | Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. | LifeServe Blood Center |
| Biologics | Red Blood Cells (Apheresis) Leukocytes Reduced | 1944382; 1944382 | Class II | Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. | LifeServe Blood Center |
| Biologics | Red Blood Cells Leukocytes Reduced | 1879895;1888158;1933200 | Class II | Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. | LifeServe Blood Center |
| Biologics | Blood and Blood Products for Reprocessing | 1879895;1888158;1933200 | Class II | Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. | LifeServe Blood Center |
| Biologics | Source Plasma | 7050250350; 7050249999; 7050249438; 7050248725; 7050248427; 7050247466; 7050246334; 7050245972; 7050244385; 7050247190; 7050242563; 7050232066; 7050231322; 7050230879; 7050230716; 7050213765; 7050213142; 7050255690; 7050212544; 7050212340; 7050211828; 7050211268; 7050209821; 7050209506; 7050209329 | Class II | Blood products, collected from a donor who received a body piercing within 12 months of donating, were distributed. | ZLB Bioplasma, Inc. |
| Biologics | Red Blood Cells (Apheresis) Leukocytes Reduced | 1978331;1978331 | Class II | Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed. | LifeServe Blood Center |
| Biologics | Red Blood Cells (Apheresis) Leukocytes Reduced | 11KJ01769 | Class II | Blood product, labeled as leukoreduced without the assurance that it met the criteria for a leukoreduced product, was distributed. | American Red Cross Blood Services |
| Biologics | Red Blood Cells | 11FV46850 | Class II | Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed. | American Red Cross Blood Services |
| Biologics | Red Blood Cells Leukocytes Reduced | 2045397 | Class III | Blood product, stored at an unacceptable temperature, was distributed. | Siouxland Community Blood Bank |
| Biologics | Red Blood Cells Leukocytes Reduced | 21GS28030. | Class II | Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed. | American National Red Cross |
| Biologics | Cryoprecipitated AHF | GX06871, GX06874 | Class II | Blood products, collected from donors whose arm scrubs were performed using expired cleanser, were distributed. | Mississippi Valley Reg Bld Ctr |
| Biologics | Red Blood Cells Leukocytes Reduced | GX06872, GX06874, GX06873, GX06870, GX06868, GX06865, GX06864, GX06869, GX06866, GX06878, GX06871 | Class II | Blood products, collected from donors whose arm scrubs were performed using expired cleanser, were distributed. | Mississippi Valley Reg Bld Ctr |
| Biologics | Source Plasma | 364009860; 364008845; 364007371; 364000437 | Class III | Blood product, collected from a donor whose donor suitability was not adequately determined, was distributed. | International BioResources, LLC |
| Biologics | Red Blood Cells Leukocytes Reduced Irradiated | 2150235 | Class III | Blood product, exposed to unacceptable shipping temperatures, was distributed. | LifeServe Blood Center |
| Biologics | Red Blood Cells Leukocytes Reduced | 2156722 | Class II | Blood component, processed from Whole Blood stored at room temperature for more than 8 hours after collection, was distributed. | LifeServe Blood Center |
| Biologics | Blood and Blood Products for Reprocessing | 011KJ12464 | Class III | Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. | American Red Cross Blood Services |
| Biologics | Red Blood Cells Leukocytes Reduced | 011KJ12464 | Class II | Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. | American Red Cross Blood Services |
| Biologics | Blood and Blood Products for Reprocessing | 011KC32262; 011KC34046 | Class III | 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 | 011KC32262; 011KC34046 | Class II | Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. | American National Red Cross (The) |
| Biologics | Blood and Blood Products for Reprocessing | 011GJ87885 | Class III | Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. | American Red Cross Blood Services |
| Biologics | Red Blood Cells | 011GJ87885 | Class II | Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. | American Red Cross Blood Services |
| Biologics | Cryoprecipitated AHF | 011GJ87885 | Class II | Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. | American Red Cross Blood Services |
| Biologics | Red Blood Cells Leukocytes Reduced | 011FY45853 | Class II | Blood product, collected from a donor who did not respond to questions regarding increased risk for vCJD, was distributed. | American Red Cross Blood Services |
| Biologics | Red Blood Cells Leukocytes Reduced | 004KM33220;004KM61922;004KM69676;004KQ32543;004KT69103 | Class II | Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. | American National Red Cross (The) |
| Biologics | Blood and Blood Products for Reprocessing | 004KM69676 | Class III | Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. | American National Red Cross (The) |
| Biologics | Plasma Frozen | 004KT69103 | Class II | Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. | American National Red Cross (The) |
| Biologics | Source Plasma | 0130050140, 0130050770, 0130051035, 0130051507, 0130051813, 0130052248, 0130052469, 0130052924, 0130053200, 0130053717 0130053996, 0130054472, 0130054718, 0130055393, 0130055563 0130056309, 0130056624, 0130057132, 0130060275, 0130060649 0130057551, 0130058315, 0130058656, 0130059009, 0130061052, 0130061496, 0130061916, 0130062474, 0130062881 | Class II | Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed. | Biomat USA, Inc. |
| Biologics | Source Plasma | 357109561; 357109081; 357107957; 357107354; 357106112; 357105645; 357104501; 357103958; 357102687; 357094085; 357093564; 357092426; 357091898; 357088997; 357088620; 357087454; 357086940; 357085683; 357085329; 357084251; 357083744; 357082438; 357082275; 357079741; 357079241; 357069722; 357069025; 357067946; 357078368; 357077347; 357076795; 357075138; 357073684; 357073023; 357071708; 357071129; 357070173; 357067075; 357065733; 357065067; 357063857; 357063168; 357061847; 357061391; 357060172; 357059540; 357058141; 357057634; 357056451; 357053823; 357052475; 357051952; 357035559; 357034481; 357034101; 357032979; 357032189; 357032103; 357110528; 357109873; 357107140; 357106296; 357103735; 357102870; 357101841; 357101557; 357100375; 357099094; 357098357; 357097748; 357096607; 357095849; 357095093; 357094461; 357093271; 357092588; 357091765; 357091125; 357089884; 357089236; 357088373; 357087824; 357085970; 357085476; 357084246; 357083805; 357079589; 357079041; 357069225; 357068756; 357067668; 357078158; 357077103; 357076502; 357075340; 357074393; 357066473; 357065819; 357064887; 357064147; 357062804; 357062109; 357060993; 357060299; 357059329; 357058634; 357057353; 357056578; 357053556; 357052720; 357051849; 357051103; 357049781; 357049065; 357048070; 357055649; 357054284; 357047050; 357045719; 357045000; 357044024; 357043219; 357042254; 357041576; 357039063; 357037951; 357037024; 357036399; 357035266; 357034687; 357033895; 357033279; 357031976; 357031440; 357030441; 357024472; 357024415; 357110220; 357109701; 357108651; 357107982; 357106937; 357106248; 357105201; 357104524; 357103487; 357102807; 357101811; 357101174; 357100182; 357099056; 357098052; 357097411; 357096439; 357095568; 357094744; 357094100; 357093083; 357092453; 357091425; 357090791; 357089806; 357089172; 357086455; 357085853; 357084856; 357084256; 357083275; 357082495; 357081800; 357081175; 357080241; 357069988; 357069505; 357068406; 357067861; 357077752; 357077180; 357076030; 357075594; 357074024; 357073349; 357072279; 357071597; 357066370; 357065602; 357064570; 357063871; 357062720; 357062036; 357060878; 357060195; 357059019; 357058339; 357057168; 357056488; 357053271; 357052643; 357051455; 357050796; 357049626; 357048984; 357047804; 357055683; 357047066; 357045916; 357045219; 357044151; 357043446; 357042354; 357041674; 357040729; 357040096; 357039104; 357038016; 357037065; 357036449; 357035507; 357034902; 357033976; 357033385; 357032516; 357031468; 357060732; 357055380; 357055212; 357038647; 357076091; 357074481; 357072414; 357071896; 357066409; 357065901; 357064615; 357064174; 357062272; 357060538; 357059826; 357058647; 357057962; 357056110; 357052955; 357052294; 357051109; 357050411; 357049362; 357048621; 357047561; 357054857; 357047368; 357046004; 357045493; 357044221; 357043743; 357042369; 357041698; 357040653; 357040069; 357039085; 357037754; 357036972; 357036130; 357035421; 357034572; 357033912; 357033059; 357051278; 357050537; 357049489; 357048781; 357047670; 357055507; 357046882; 357044083; 357040638; 357040081; 357038272; 357038538; 357024411; 357091656; 357090309; 357089977; 357088644; 357088327; 357086915; 357086331; 357085071; 357084462; 357083540; 357082833; 357082072; 357081399; 357080487; 357079783; 357069973; 357069427; 357068419; 357078388; 357077672; 357076733; 357076015; 357074282; 357073553; 357072464; 357071780; 357070731; 357070219; 357066637; 357065765; 357064848; 357064127; 357063019; 357062268; 357061060; 357060542; 357059258; 357058572; 357057371; 357056705; 357053527; 357052798; 357051706; 357051020; 357049913; 357049200; 357048038; 357055856; 357054196; 357047234; 357046115; 357045399; 357044288; 357043628; 357042592; 357041923; 357040958; 357040218; 357039277; 357038171; 357037252; 357036603; 357035669; 357035011; 357034169; 357033513; 357032688; 357031569; 357030789; 357030160; 357029440; 357028910; 357028181; 357027643; 357026952; 357026473; 357025814; 357025371; 357024741; 357023802; 357023223; 357022808; 357022303; 357021934; 357021417; 357021034; 357018253; 357018228 | Class II | Blood products, collected from a donor who may have received a body piercing within 12 months of donating, were distributed. | Talecris Plasma Resources, Inc. |
| Biologics | Source Plasma | 364056760; 364056522; 364049532; 364047809; 364045459; 364048905; 364048188; 364050495; 364047136; 364050876; 364045753; 364053409; 364045610; 364049784; 364050211; 364045655; 364056254; 364056878; 364058573; 364045975; 364053779; 364056517; 364057800; 364051610; 364056989; 364055003; 364050480; 364046017; 364048953; 364053776; 364051091; 364050883; 364049994; 364048773; 364048539; 364047844; 364056210; 364055887; 364054765; 364053392; 364049555; 364051881; 364047076; 364048418; 364049620; 364051647; 364051990; 364052046; 364052580; 364053683; 364055261; 364055249; 364049024; 364050665; 364058251; 364050330; 364048414; 364051524; 364052060; 364053414; 364050014; 364056391; 364052896; 364051993; 364048555; 364046739; 364046524; 364050607; 364046519; 364046476; 364058086; 364056869; 364060504; 364056586; 364054261; 364054118; 364050272; 364050216; 364052443; 364061314; 364057861; 364056675; 364049508; 364047675; 364052120; 364053412; 364055050; 364054839; 364058172; 364057624; 364056893; 364053690; 364050590; 364046297; 364054354; 364054614; 364048620; 364054065; 364053444; 364045779; 364051926; 364050269; 364045536; 364055406; 364047807; 364049769; 364056417; 364051486; 364050166; 364050442; ;364055138; 364047495; 364046960; 364055907; 364049166; 364048230; 364045790; 364048913; 364056565; 364054592; 364049832; 364058175; 364048228; 364048243; 364046937; 364047168; 364051482; 364051865; 364052252; 364052614; 364054925; 364060158; 364048115; 364048287; 364045968; 364056609; 364053465; 364053120; 364052903; 364052608; 364051641; 364050085; 364055025; 364050933; 364050742; 364050636; 364053130; 364045979; 364045947; 364054949; 364056864; 364056530; 364051911; 364048572; 364046886; 364049194; 364050594; 364046888; 364046015; 364047589; 364054788; 364054650; 364050573; 364049213; 364050863; 364052032; 364052938; 364056781; 364057805; 364048898; 364048075; 364047124; 364055098; 364047466; 364052626; 364047135; 364058219; 364057527; 364058657; 364046489; 364047600; 364057580; 364050114; 364047107; 364059834; 364055055; 364051816; 364056471; 364046303; 364044404; 364054345; 364053686; 364051239; 364047468; 364051988; 364047210; 364057514; 364055344; 364048094; 364045372; 364047175; 364047858; 364048552; 364052254; 364058196; 364047811; 364046851; 364045766; 364059840; 364055109; 364049382; 364045773; 364045709; 364047112; 364049210; 364050940; 364052096; 364054885; 364060252; 364061311; 364052257; 364051522; 364047174; 364055341; 364057522; 364050489; 364048782; 364047229; 364045987; 364055514; 364050587; 364048868; 364051253; 364049477; 364048866; 364048601; 364049447; 364049216; 364049480; 364046502; 364053803; 364048922; 364048211; 364046010; 364052727; 364047213; 364052949; 364050202; 364053481; 364048059; 364047162; 364046535; 364056055; 364055845; 364047154; 364056894; 364054126; 364052955; 364052433; 364051939; 364050539; 364055491; 364057574; 364056228; 364052934; 364049228; 364048970; 364047633; 364047514; 364049445; 364049810; 364052651; 364047787; 364048949; 364045861; 364048857; 364053405; 364055905; 364058585; 364048271; 364051248; 364052052; 364055346; 364059909; 364045899; 364049161; 364049391; 364052043; 364052557; 364053679; 364054040; 364054264; 364054797; 364050343; 364046348; 364048258; 364047557; 364059858; 364056564; 364056401; 364056159; 364053468; 364052861; 364052235; 364049495; 364047459; 364052586; 364052077; 364051632; 364055140; 364045394; 364046558; 364051484; 364057831; 364048081; 364047903; 364047202; 364046560; 364045407; 364047552; 364050617; 364046832; 364047224; 364047457; 364047900; 364052916; 364057700; 364056897; 364055258; 364047577; 364060532; 364060189; 364061250; 364055169; 364048221; 364052704; 364057266; 364047550; 364047856; 364048291; 364050519; 364050186; 364056243; 364047518; 364046822; 364046304; 364046752; 364045363; 364047925; 364048124; 364051344; 364052067; 364052273; 364045746; 364054159; 364052256; 364054733; 364049783; 364054668; 364049570; 364046464; 364046568; 364047606; 364054942; 364054576; 364053445; 364049492; 364047101; 364053784; 364052238; 364051951; 364047802; 364046896; 364054953; 364054585; 364054073; 364053820; 364052720; 364057838; 364046864; 364047547; 364049582; 364046486; 364050685; 364055271; 364047149; 364047841; 364048043; 364056620; 364046952; 364046787; 364045561; 364057233; 364058298; 364049510; 364051929; 364054609; 364054996; 364047850; 364055201; 364055279; 364055238; 364048056; 364045781; 364050497; 364055918; 364048086; 364050739; 364051878; 364051488; 364050867; 364049220; 364047083; 364046451; 364050484; 364055839; 364051355; 364047529; 364052830; 364051605; 364051886; 364045859; 364051517; 364053367; 364054841; 364056436; 364055718; 364054023; 364051786; 364057672; 364055091; 364045692; 364050019; 364048446; 364047171; 364047573; 364054737; 364059896; 364046590; 364046286; 364046242; 364052864; 364046002; 364047111; 364051945; 364052446; 364055325; 364047092; 364054829; 364046043; 364046024; 364047669; 364049010; 364058644; 364057497; 364049457; 364048442; 364047832; 364047237; 364046018; 364050958; 364049413; 364048797; 364047867; 364052665; 364050434; 364053004; 364055264; 364055099; 364046479; 364047587; 364046828; 364053815; 364058324; 364046965; 364047798; 364048421; 364051277; 364052987; 364057833; 364046868; 364050649; 364058164; 364054785; 364053825; 364052931; 364052297; 364052094; 364050736; 364048113; 364047473; 364046806; 364046276; 364045489; 364059828; 364055327; 364049472; 364057853; 364053475; 364055239; 364056795; 364047580; 364047220; 364046884; 364050113; 364045376; 364045928; 364058091; 364058334; 364054640; 364053447; 364052555; 364052030; 364047066; 364046443; 364045453; 364050293; 364061334; 364060122; 364048799; 364048242; 364046492; 364054545; 364045769; 364052263; 364049641; 364050741; 364057571; 364050116; 364050148; 364057591; 364057223; 364054274; 364054861; 364056598; 364057705; 364058116; 364050118; 364045844; 364048818; 364049132; 364057252; 364056269; 364054391; 364054157; 364053006; 364047119; 364046500; 364047498; 364049548; 364051665; 364058131; 364059859; 364061069; 364061460; 364056256; 364046772; 364048064; 364047186; 364055139; 364057859; 364048077; 364048558; 364055390; 364056820; 364058146; 364058732; 364057667; 364048269; 364053346; 364048879; 364047643; 364045877; 364049154; 364050157; 364051626; 364048050; 364054865; 364047216; 364054649; 364055232; 364054645; 364050316; 364046483; 364056777; 364054583; 364048096; 364049444; 364046294; 364048126; 364053141; 364053418; 364056067; 364057243; 364047482; 364048566; 364050463; 364050475; 364045825; 364047804; 364045661; 364045682; 364050922; 364049440; 364049196; 364045700; 364051463; 364050861; 364048978; 364048535; 364047536; 364059866; 364054793; 364048780; 364045715; 364048209; 364050638; 364051611; 364055093; 364048238; 364053008; 364046238; 364050150; 364052075; 364051874; 364051342; 364049565; 364052739; 364051251; 364050896; 364052073; 364058099; 364060166; 364059814; 364045972; 364047189; 364050174; 364049786; 364046749; 364052908; 364054961; 364046988; 364058379; 364054838; 364047194; 364061416; 364056594; 364053797; 364046797; 364051659; 364047144; 364051533; 364055046; 364056858; 364048871; 364052993; 364052640; 364048821; 364047813; 364054854; 364053493; 364051998; 364055100; 364055127; 364058672; 364055177; 364051601; 364052711; 364051862; 364050652; 364052101; 364049443; 364046744; 364055149; 364054596; 364050466; 364050474; 364051230; 364049554; 364046026; 364056616; 364048943; 364053504; 364052923; 364050746; 364048814; 364047825; 364047602; 364047110; 364060268; 364053502; 364051552; 364051569; 364051946; 364047148; 364047835; 364051622; 364052910; 364054146; 364058577; 364056155; 364051270; 364051629; 364045356; 364048301; 364047177; 364046255; 364054892; 364050505; 364049842; 364049395; 364048784; 364048548; 364046931; 364052661; 364051494; 364048549; 364048278; 364050492; 364051501; 364050929; 364050153; 364054253; 364053342; 364050033; 364056652; 364055704; 364054242; 364045477; 364046924; 364061680; 364061073; 364054670; 364048989; 364057606; 364050465; 364057500; 364045848; 364054926; 364046257; 364046907; 364046284; 364053561; 364045587; 364054019; 364061553; 364060471; 364057214; 364056634; 364056239; 364054601; 364054111; 364049558; 364048894; 364056809; 364049172; 364048788; 364047888; 364051965; 364049790; 364055141; 364048602; 364047567; 364050273; 364052039; 364048863; 364045905; 364060164; 364060494; 364060213; 364061241; 364060537; 364055259; 364046222; 364046532; 364054723; 364056069; 364056655; 364056957; 364057227; 364058370; 364060090; 364061170; 364061586; 364045209; 364051282; 364059980; 364050949; 364049845; 364048647; 364054859; 364056673; 364053009; 364053582; 364054164; 364046234; 364048638; 364056806; 364061037; 364061353; 364047640; 364051657; 364052835; 364058170; 364060468; 364061546; 364049525; 364050614; 364056660; 364044894; 364047167; 364049631; 364057612; 364056674; 364056525; 364049018; 364047789; 364061611; 364061406; 364045246; 364047527; 364048938; 364045450; 364046890; 364047534; 364048190; 364052291; 364053394; 364054129; 364058230; 364054660; 364051686; 364055198; 364057711; 364058257; 364049127; 364048975; 364048538; 364048374; 364050575; | Class III | Blood product, collected from a donor whose donor suitability was not adequately determined, was distributed. | Talecris Plasma Resources, Inc. |
| Biologics | Red Blood Cells Leukocytes Reduced Washed | 55R77401 | Class III | Blood product, for which the red cell count and hematocrit were outside the acceptable range, was distributed. | American National Red Cross (The) |
| Biologics | Red Blood Cells Leukocytes Reduced | W047011056156, W047011326288, W047011330978, W047011334076, W047011337255, W047011337381, W047011351793, W047011338532, W047011342807, W047011336499, W047011342268, W047011333963, W047011336452, W047011349758, W047011335665, W047011333350, W047011333374, W047011333379, W047011333639, W047011333978, W047011334415, W047011334422, W047011334456, W047011334645, W047011333639, W047011336682, W047011337465, W047011337580, W047011338365, W047011337942, W047011339511, W047011339543, W047011339863, W047011339875, W047011341197, W047011341225, W047011341577, W047011341654, W047011341697, W047011341943, W047011342052, W047011342061, W047011342456, W047011342822, W047011344129, W047011344906, W047011345097, W047011345107, W047011345129, W047011345528, W047011345752, W047011346513, W047011347560 (2 units), W047011347841, W047011351263, W047011326528 | Class II | Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. | New York Blood Center, Inc. |
| Biologics | Platelets Pheresis Leukocytes Reduced Irradiated | W047011326254, W047011326489, W047011339265, W047011339427 | Class II | Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. | New York Blood Center, Inc. |
| Biologics | Cryoprecipitated AHF | W047011330978, W047011333350, W047011333374, W047011333379, W047011333639, W047011334645, W047011333639, W047011337580, W047011339543, W047011342822, W047011344906, W047011345097 | Class II | Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. | New York Blood Center, Inc. |
| Biologics | Recovered Plasma | W047011326288, W047011330967, W047011330978, W047011336499, W047011326528, W047011332975, W047011333350, W047011333374, W047011333379, W047011333639, W047011334415, W047011334456, W047011337580, W047011339543, W047011341943, W047011342456, W047011342822, W047011347560 | Class III | Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. | New York Blood Center, Inc. |
| Biologics | Platelets Pheresis Leukocytes Reduced | W047011325144 (2 units), W047011341398 (2 units), W047011326254, W047011329482 (2 units), W047011348802 (2 units), W047011326489, W047011332206 | Class II | Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. | New York Blood Center, Inc. |
| Biologics | Red Blood Cells (Apheresis) Leukocytes Reduced | W047011325181 (2 units), W047011333860 (2 units), W047011343932 (2 units), W047011350111 (2 units) | Class II | Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. | New York Blood Center, Inc. |
| Biologics | Plasma Frozen within 24 hours (FP24) | W047011056156, W047011336625, W047011336682, W047011338416, W047011339863, W047011342052, W047011342061 | Class II | Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. | New York Blood Center, Inc. |
| Biologics | Cryoprecipitated AHF, Pooled | W047011328328, W047011328374, W047011341225, W047011351793, W047011467903, W047011467980 | Class II | Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. | New York Blood Center, Inc. |
| Biologics | Red Blood Cells Leukocytes Reduced Irradiated | W047011332975, W047011333909, W047011336625 (2 units), W047011338416, W047011338548, W047011342870 | Class II | Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. | New York Blood Center, Inc. |
| Biologics | Fresh Frozen Plasma | W047011336452 | Class II | Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. | New York Blood Center, Inc. |
| Biologics | Plasma Cryoprecipitate Reduced | W047011342870, W047011345097 | Class II | Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. | New York Blood Center, Inc. |
| Biologics | Source Plasma | SS0028297, SS0028810, SS0029396, SS0029992, SS0030710, SS0031173, SS0032411, SS0032571, SS0033526, SS0034910, SS0033790, SS0035135, SS0040286, SS0040977, SS0041971, SS0042322, SS0046118, SS0046508, SS0049341, SS0054262, SS0054851, SS0055786, SS0056509 | Class II | Blood products, collected from a donor with a history of high-risk behavior, were distributed. | DCI Biologicals LLC |
| Biologics | Red Blood Cells Leukocytes Reduced | 033KX34123, 033KX34094, 033KX34095, 033KX34096, 033KX34097, 033KX34098, 033KX34099, 033KX34101, 033KX34102, 033KX34103, 033KX34104, 033KX34105, 033KX34106, 033KX34107, 033KX34124, 033KX34125, 033KX34126, 033KX34127, 033FN44900, 033FN44901, 033FN44890, 033FN44891, 033FN44893, 033FN44894, 033FN44895, 033FN44897, 033FN44898, 033FN44899, 033FN44879, 033FN44880, 033FN44881, 033FN44882, 033FN44883, 033FN44884, 033FN44885, 033FN44886, 033FN44887, 033FN44888, 033FN44889, 033KX34131, 033KX34132, 033KX34133, 033KX34134, 033KX34136, 033KX34138, 033KX34139, 033KX34140, 033KX34141, 033KX34129, 033KX34130, 033FN44851, 033FN44852, 033FN44853, 033FN44854, 033FN44855, 033FN44856, 033FN44857, 033FN44858, 033FN44859, 033FN44860, 033FN44862, 033FN44863, 033FN44864, 033FN44866, 033FN44868, 033FN44869, 033FN44870, 033FN44871, 033FN44873, 033FN44874, 033FN44875, 033FN44876, 033FN44878, 033KX34142, 033KX34143, 033KX34144, 033KX34145, 033KX34146, 033FN44847, 033FN44849, 033FN44850, 033KX34108, 033KX34109, 033KX34110, 033KX34111, 033KX34112, 033KX34113, 033KX34114, 033KX34115, 033KX34116, 033KX34117, 033KX34118, 033KX34119, 033KX34120, 033KX34121, 033KX34122, 033FN44903, 033FN44905, 033FN44906, 033FN44907, 033FN44908, 033FN44909, 033FN44910, 033FN44911, 033FN44912, 033FN44914 | Class III | Blood products, for which the scale and Hemocue used during collection failed quality control testing, were distributed. | American National Red Cross (The) |
| Biologics | Red Blood Cells Leukocytes Reduced Irradiated | 033KX34128, 033FN44892, 033FN44865, 033FN44846, 033FN44902, 033FN44913, 033FN44915 | Class III | Blood products, for which the scale and Hemocue used during collection failed quality control testing, were distributed. | American National Red Cross (The) |
| Devices | Liko Overhead Rail System Product Usage - The Overhead Rail System allows overhead lifts to be mounted to the ceiling allowing versatility for use in lifting situations. It can be used with different Liko ceiling lifts. | The Liko Overhead Rail System components are not serialized and have been distributed since the early 1980's to the present. | Class II | Liko/Hill-Rom to date has received two reports from facilities alleging that the overhead rail system has failed to the extent that the overhead rails have fallen down while in use in high humidity (swimming pool) areas. Analysis of the incidents suggest that the components (hardware) used to secure the rail to the ceiling had corroded and may be unsuitable for environments with an atmosphere containing chlorine. | Hill-Rom, Inc. |
| Devices | Stryker Sustainability Solutions, AC Power Adaptor for Restep Deep Vein Thrombosis (DVT) System, an external compression system. PUMPKIT (Pump Kit), and RSP159-01 - AC Power Adaptor. | 108851407, 108851408, 108870192, 108874144, 108883271, 108886340, and 108888023. | Class II | Reports that the AC Power Adaptor may not operate due to wires coming loose in the unit. | Stryker Sustainability Solutions |
| Devices | LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects. | Part number: 198720018 and Lot numbers: 123506, 123507, 156208, 188414, 202951, 212351, B34GC1000, B4EGN1000, B4SBM1000, B5SHY1000, DH8F91000, DH8F9A000, DH8F9B000, DH8F9C, and FE5LL1. | Class I | DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the product has the potential for fracture at the taper junction. The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients. | DePuy Orthopaedics, Inc. |
| Devices | LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects. | Part number: 198720020 and Lot numbers: 140576, 156212, 156213, 156214, 162644, 188411, 202954, 156214A, 202954A, B34GD1000, B4SBN1000, B4SBNA000, B4SBNB000, B4SBNC000, B5RAW1000, B5RAWA000, C3RHJ1000, C74JX1000, C74JXA, E18N61000, E3PKV1000, EF8GB1000, and FL2WB1. | Class I | DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the product has the potential for fracture at the taper junction. The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients. | DePuy Orthopaedics, Inc. |
| Devices | LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects. | Part number: 198720024 and Lot numbers: 113812, 123509, 140578, 156210, 171659, 171660, 171661, 171662, 171663, 123509A, B34GE1000, B34GEA000, B4EGR1000, B4EGRA000, B4EGRB000, B4XFL1000, B4XFLA000, B5SH11000, B5SH1A000, B5SH1B, C74J11000, D14KG1000, E4RF21000, EN8CY1000, EN8CYA000, FC1MB1, and FC1MBA. | Class I | DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the product has the potential for fracture at the taper junction. The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients. | DePuy Orthopaedics, Inc. |
| Devices | LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects. | Part number: 198720028 and Lot numbers: 123510, 156211, 212355, B34GG1000, B4TH51000, B5RAX1000, B5RAXA000, B5RAXB000, CC3KX1000, CC3KXA000, E4RF31000, E4RF3A000, E55HV1, and EN4KN1000. | Class I | DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the product has the potential for fracture at the taper junction. The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients. | DePuy Orthopaedics, Inc. |
| Drugs | Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg; 100 Tablets (5 x 20), 5 cards each containing 20 blistered tablets per carton, Rx only; Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, Pkg by & Distributed by UDL Laboratories, Inc., Rockford, IL 61103; NDC 51079-254-21. | Lot #: 3037841, 3040859, 3042573, Exp 12/13 | Class I | Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components. | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) |
| Devices | HealthTronics Endocare 3.8mm RenalCryo Cryoprobe, R3.8L, Endocare, Inc., a wholly owned subsidiary of HealthTronics, Inc., 9825 Spectrum Dr. Building 3, Austin, TX 78717 The Endocare CryoProbe is an accessory probe intended for use with the CryoCare Surgical System. The CryoCare Surgical System is intended for use in surgical procedures in the arrears of general surgery, dermatology, neurology, thoracic surgery, pulmonary surgery, | Lot 10180, Expiration date on box is 2105-07. Model Number R3.8L | Class II | The Endocare 3.8mm RenalCryo Cryoprobe is being recalled because the label on the outer box has the incorrect expiration date. | Healthtronics, Inc. |
| Drugs | SLIMDIA Revolution capsules, 30-count capsules per bottle, Yerba Naturals, 19685 Varda Ave., Buena Park, CA. | There are no manufacturing codes associated with the product. | Class I | Marketed Without an Approved NDA/ANDA: All lots of the dietary supplement Slimdia Revolution are being recalled because they contain sibutramine, a previously approved FDA drug removed from the U.S. marketplace for safety reasons, making it an unapproved new drug. | P & J Trading Co |
| Devices | Pro Time Microcoagulation System/ Pro Time 3 Cuvette International Technidyne Corporation 23 Nevsky Street Edison, NJ 08820 The Pro Time Microcoagulation System is a portable batter operated instrument with a disposable cuvette for quantitative determination of prothrombin time from fingerstick whole blood or anticoagulant free venous whole blood. | Pro3-25 A2K3C001 1/31/2013 A2K3C002 1/31/2013 A2P3C003 1/31/2013 A2P3C004 1/31/2013 A2K3C005 1/31/2013 A2K3C006 1/31/2013 A2K3C007 1/31/2013 A2K3C008 1/31/2013 A2K3C009 1/31/2013 A2K3C011 1/31/2013 A2K3C013 1/31/2013 A2K3C015 1/31/2013 A2K3C016 1/31/2013 A2K3C017 1/31/2013 A2K3C018 1/31/2013 A2K3C019 1/31/2013 A2K3C020 1/31/2013 A2K3C021 1/31/2013 A2K3C022 1/31/2013 A2K3C023 1/31/2013 2K3C024 1/31/2013 A2K3C025 1/31/2013 A2K3C026 1/31/2013 A2K3C027 1/31/2013 B2K3C028 2/28/2013 B2K3C030 2/28/2013 B2K3C031 2/28/2013 B2K3C032 2/28/2013 B2K3C033 2/28/2013 B2K3C034 2/28/2013 B2K3C035 2/28/2013 B2K3C036 2/28/2013 B2K3C037 2/28/2013 B2K3C038 2/28/2013 B2K3CO39 2/28/2013 B2K3C040 2/28/2013 B2K3C041 2/28/2013 B2K3C042 2/28/2013 B2K3C043 2/28/2013 B2K3C044 2/28/2013 B2K3C045 2/28/2013 B2K3C046 2/28/2013 C2K3C048 3/31/2013 C2K3C049 3/31/2013 C2K3C050 3/31/2013 C2K3C051 3/31/2013 C2K3C052 3/31/2013 C2K3C053 3/31/2013 C2K3C054 3/31/2013 C2K3C055 3/31/2013 C2K3C056 3/31/2013 C2K3C058 3/31/2012 C2K3C059 3/31/2013 C2K3C061 3/31/2013 D2K3C078 4/30/2013 M1K3C474 12/31/2012 M1K3C475 12/31/2012 M1K3C477 12/31/2012 M1P3C478 12/31/2012 M1P3C479 12/31/2012 M1P3C480 12/31/2012 M1P3C481 12/31/2012 M1P3C482 12/31/2012 PRO3-4 A2K3H015 1/31/2013 B2K3H029 2/28/2013 B2K3H033 2/28/2013 B2K3H047 2/28/2013 C2K3H049 3/31/2013 C2K3H055 3/31/2013 C2K3H057 3/31/2013 PRO3-50 B2P3C029 2/28/2013 B2P3C030 2/28/2013 B2O3C033 2/28/2013 C2P3C057 3/31/2013 | Class II | Some Pro Time3 Test Cuvettes within a specified lot range may recover lower than expected Prothrombin Time/International Normalized Ratio (PT/INR) results. | International Technidyne Corp. |
| Drugs | Crest PRO-HEALTH CPC Antigingivitis/Antiplaque Oral Rinse, 250 mL (8.4 fl oz),Dist. by Procter & Gamble, Cincinnati, OH 45202 NDC 37000-452-02 | 22155395UA Expires: 07/2014 | Class III | Cross Contamination with Other Products: Product was mixed with another type of mouth wash. | Procter & Gamble Hair Care Llc |
| Devices | NEUROPATH 6Fx90 GUIDING CATH MPC Product Code: GMC60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices | All unexpired lots | Class II | Sterility of device may be compromised due to lack of packaging integrity | Codman & Shurtleff, Inc. |
| Devices | NEUROPATH 5Fx90 GUIDING CATH S2 Product Code: GSM50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices | All unexpired lots | Class II | Sterility of device may be compromised due to lack of package integrity | Codman & Shurtleff, Inc. |
| Devices | NEUROPATH 6Fx90 GUIDING CATH HH Product Code: GHH60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices | All unexpired lots | Class II | Sterility of device may be compromised due to lack of package integrity | Codman & Shurtleff, Inc. |
| Devices | NEUROPATH 5Fx100 GUIDING CATH HH Product Code: GHH51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices | All unexpired lots | Class II | Sterility of device may be compromised due to lack of package integrity | Codman & Shurtleff, Inc. |
| Devices | NEUROPATH 5Fx100 GUIDING CATH HH Product Code: GMC51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices | All unexpired lots | Class II | Sterility of device may be compromised due to lack of package integrity | Codman & Shurtleff, Inc. |
| Devices | NEUROPATH 6Fx100 GUIDING CATH MPD Product Code: GMD60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices | All unexpired lots | Class II | Sterility of device may be compromised due to lack of package integrity | Codman & Shurtleff, Inc. |
| Devices | NEUROPATH 5Fx100 GUIDING CATH MP Product Code:GMD51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices | All unexpired lots | Class II | Sterility of device may be compromised due to lack of package integrity | Codman & Shurtleff, Inc. |
| Devices | NEUROPATH 6Fx100 GUIDING CATH ST Product Code: GST61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices | All unexpired lots | Class II | Sterility of device may be compromised due to lack of package integrity | Codman & Shurtleff, Inc. |
| Devices | NEUROPATH 5Fx100 GUIDING CATH S2 Product Code: GSM51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices | All unexpired lots | Class II | Sterility of device may be compromised due to lack of package integrity | Codman & Shurtleff, Inc. |
| Devices | NEUROPATH 6Fx100 GUIDING CATH MC Product Code: GCB61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices | All unexpired lots | Class II | Sterility of device may be compromised due to lack of package integrity | Codman & Shurtleff, Inc. |
| Devices | NEUROPATH 6Fx100 GUIDING CATH S2 Product Code: GSM61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices | All unexpired lots | Class II | Sterility of device may be compromised due to lack of package integrity | Codman & Shurtleff, Inc. |
| Devices | NEUROPATH 5Fx100 GUIDING CATH MC Product Code: GCB51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices | All unexpired lots | Class II | Sterility of device may be compromised due to lack of package integrity | Codman & Shurtleff, Inc. |
| Devices | NEUROPATH 5Fx90 GUIDING CATH MCV Product Code: GCB50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices | All unexpired lots | Class II | Sterility of device may be compromised due to lack of package integrity | Codman & Shurtleff, Inc. |
| Devices | NEUROPATH 5Fx90 GUIDING CATH MPC Product Code: GMC50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices | All unexpired lots | Class II | Sterility of device may be compromised due to lack of package integrity | Codman & Shurtleff, Inc. |
| Devices | NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMD61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices | All unexpired lots | Class II | Sterility of device may be compromised due to lack of package integrity | Codman & Shurtleff, Inc. |
| Devices | NEUROPATH 5Fx90 GUIDING CATH MPD Product Code: GMD50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices | All unexpired lots | Class II | Sterility of device may be compromised due to lack of package integrity | Codman & Shurtleff, Inc. |
| Devices | NEUROPATH 5Fx100 GUIDING CATH ST Product Code: GST51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices | All unexpired lots | Class II | Sterility of device may be compromised due to lack of package integrity | Codman & Shurtleff, Inc. |
| Devices | NEUROPATH 5Fx90 GUIDING CATH ST Product Code: GST50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices | All unexpired lots | Class II | Sterility of device may be compromised due to lack of package integrity | Codman & Shurtleff, Inc. |
| Devices | NEUROPATH 6Fx90 GUIDING CATH ST Product Code: GST60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices | All unexpired lots | Class II | Sterility of device may be compromised due to lack of package integrity | Codman & Shurtleff, Inc. |
| Devices | NEUROPATH 5Fx90 GUIDING CATH HH Product Code: GHH50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices | All unexpired lots | Class II | Sterility of device may be compromised due to lack of package integrity | Codman & Shurtleff, Inc. |
| Devices | NEUROPATH 6Fx90 GUIDING CATH MCV Product Code: GCB60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices | All unexpired lots | Class II | Sterility of device may be compromised due to lack of package integrity | Codman & Shurtleff, Inc. |
| Devices | NEUROPATH 6Fx90 GUIDING CATH S2 Product Code: GSM60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices | All unexpired lots | Class II | Sterility of device may be compromised due to lack of package integrity | Codman & Shurtleff, Inc. |
| Devices | NEUROPATH 6Fx100 GUIDING CATH HH Product Code: GHH61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices | All unexpired lots | Class II | Sterility of device may be compromised due to lack of package integrity | Codman & Shurtleff, Inc. |
| Devices | NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMC61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices | All unexpired lots | Class II | Sterility of device may be compromised due to lack of package integrity | Codman & Shurtleff, Inc. |
| Devices | MAYFIELD® Composite Series Base Unit Standard, Model (A3101), Rx ONLY, Integra LifeScience Corporation, 4900 Charlemar Drive, Building A, Cincinnati, OH 45227 The MAYFIELD® Base Units are intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is required and where X-ray imaging modalities will be used. | Model # A3101 Base Units Serial No's: SB120016, SB120017, SB120019, SB120020, SB120021, SB120022, SB120023, SB120024, SB120025, SB120026, SB120027, SB120028, SB120029, SB120030, SB120031, SB120032, SB120134, SB120036, SB120037, SB120038, SB120040, SB120042, SB120043, SB120044, SB120045, SB120049, SB120050, SB120051, SB120052, SB120053, SB120054, SB120055, SB120056, SB120057, SB120058, SB120059, SB120060, SB120061, SB120062, SB120063, SB120064, SB120065, SB120066, SB120067, SB120068, SB120069, SB120070, SB120071, SB120072, SB120073, SB120074, SB120075, SB120076, SB120077, SB120078, SB120079, SB120080, SB120081, SB120082, SB120083, SB120084, SB120085, SB120086, SB120087, SB120088, SB120089, SB120090, SB120091, SB120092, SB120093, SB120094, SB120095, SB120096, SB120097, SB120098, SB120099, SB120100, SB120107, SB120108, SB120109, SB120111, SB120112, SB120113, SB120114, SB120115, SB120116, SB120117, SB120118, SB120119, SB120120, SB120121, SB120122, SB120129, SB120131, SB120138 & SB120141. | Class II | Integra determined there is a possibility that the Base Units may break during use. | Integra LifeSciences Corp. |
| Food/Cosmetics | Thomas' Bagels, 1 lb 4 oz packages; EVERYTHING, ONION, BLUEBERRY, PLAIN, CINNAMON RAISIN, HEARTY GRAINS 100% WHOLE WHEAT, CINNAMON SWIRL and HONEY WHEAT varieties. | Best buy dates (month and day) "JAN 18" to and including "JAN 27" found on the lock tab bag closures in the following states: AL, FL, GA and TN. | Class II | The firm found metal fragments in two packages of product. | Bimbo Bakeries Usa |
| Food/Cosmetics | Sara Lee Deluxe Bagels, 20 oz packages; BLUEBERRY, PLAIN, CINNAMON RAISIN,and HONEY WHEAT varieties. | Best buy dates (month and day) "JAN 18" to and including "JAN 27" found on the lock tab bag closures in the following states: AL, FL, GA, LA, MS, NC, SC and TN. | Class II | The firm found metal fragments in two packages of product. | Bimbo Bakeries Usa |
| Food/Cosmetics | Publix Premium Bagels, 20 oz packages; ORIGINAL, MULTI-GRAIN, and CINNAMON RAISIN SWIRL varieties. | Best buy dates (month and day) "JAN 18" to and including "JAN 27" found on the lock tab bag closures in the following states: AL, FL, SC and TN. | Class II | The firm found metal fragments in two packages of product. | Bimbo Bakeries Usa |
| Food/Cosmetics | Weight Watchers 6 Original Bagels, 15 oz packages | Best buy dates (month and day) "JAN 18" to and including "JAN 27" found on the lock tab bag closures in the following states: AL, FL, GA, NC, SC and TN. | Class II | The firm found metal fragments in two packages of product. | Bimbo Bakeries Usa |
| Biologics | Platelets Pheresis Leukocytes Reduced Irradiated | W313712022984 | Class III | Blood product, collected from a donor with an initially positive test for syphilis, was distributed. | Hemacare Corporation |
| Devices | Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290 The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support or defibrillation | Serial number range: USO1100100 - USO1100372, USN1100376 - USN1100960, USD1100961 - USD1101095, US11201096 - US11201186, US21201187 - US21201239, US31201240 - US31201537, US41201538 - US41201585, US51201586 - US51201721, US61201722 -US61201924, US71201925 - US71202048, US81202049 - US81202168, US91202169- US91202514, USO1202515 - USO1202990, USN1202991 - USN1203537, USD1203538- USD1203968, US11303969 - US11303972 | Class II | Philips HeartStart XL+ Defibrillator/Monitor may become locked out of clinical use | Philips Healthcare Inc. |
| Devices | Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary system. | Lot numbers H399931S1; H411376; H399938S1; H411373; H399940S1; H411374; H399942S1; H411375; H399948S1; H411380; H399950S1; H411377; H39952S1; H411378; H39953S1; H411379. | Class II | Merit Medical Systems is recalling certain lots of ReSolve Biliary Locking Drainage Catheters due to a consumer complaint that a catheter was observed to be in several pieces under patient fluoroscopic visualization. | Merit Medical Systems, Inc. |
| Devices | CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a needle or catheter inserted into the patient's artery or vein. | Lot number 12055225 | Class II | CareFusion is recalling the SmartSite® Gravity Blood Set as a result of a potential for separation at the connection of the drip chamber and tubing . The separation may be observed at priming or observed during use. If a separation between the drip chamber and tubing occurs, this could cause a delay in treatment. | Carefusion 303 Inc |
| Biologics | Vascular Graft | 9887377; 9887385; 9887396; 9887480 | Class II | Human Tissues, recovered from a donor whose donor eligibility determination did not identify if the donor was free from risk factors for and clinical evidence of, infection due to relevant communicable disease agents, were distributed. | CryoLife, Inc. |
| Devices | Vascular Solutions, SuperCross Microcatheter, Sterilized using ethylene oxide, Rx Only, Model numbers 5300 - 5307, 5324, 5325, 5329, 5332, 5336, 5340, and 5341. Product Usage: The SuperCross catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to subselectively infuse/deliver diagnostic and therapeutic agents | 559450, 551750, 552370, 552761, 552840, 552954, 553267, 553647, 553931, 554269, 554270, 554413. 555958, 557192, 557824, 558222, 558894, 559827, 560215, 551751, 552371, 552841, 553090, 553218, 553434, 553529, 554029, 554268, 554271, 555759, 555953, 557251, 559570, 559981, 560253, 560079, 560080, 554123, 556182, 558905, 560114, 554210, 555991, 556842, 557253, 554209, 555223, 555992, 556536, 556747, 557124, 558327, 558991, 560115, 561206, 554208, 555490, 555993, 556674, 556843, 558018, 558798, 559707, 560433, 561207, 554040, 555007, 555224, 555358, 558542, 560434, 561459, 554122, 555008, 555225, 555994, 558992, 561208, 560221, 560222, 560223, 560995, 560996. | Class II | Vascular Solutions, Inc has discovered a potential problem with a number of lots of Supercross microcatheters. A potential for surface contamination on aged catheters was observed during in-house testing. | Vascular Solutions, Inc. |
| Biologics | Cornea | PH109275OS; PH109275OD | Class II | Human Corneas, recovered in a manner that increased the risk of the introduction, transmission, or spread of communicable disease, were distributed. | Heartland Lions Eye Bank |
| Food/Cosmetics | A soft brie-style cheese called Jewell. Ingredients: Certified organic cows' milk, Pasteurized farmstead goats' milk, cultures, rennet and salt. (information obtained from firm's web site) | Packages are labeled with a "born on date" along with the weight of the package. The cheeses range in weight. The package also contains a packaged date which represents the date shipped. | Class II | Improperly pasteurized. | Tumalo Farms LLC |
| Food/Cosmetics | A soft chevre-style cheese. Label reads in part, "*** TUMALO FARMS Artisan Cheeses of Central Oregon Chevita This fresh and mild, soft, white cheese has a great tangy finish www.tumalofarms.com *** Ingredients . Pasteurized Goats' Milk, Culture, Rennet and Salt." | Product is coded with a "born on date" and weight (individual cheese packages are different weight. The product also has a packaged date, which is the same as the ship date. there are 2 born on dates - 1/10/13 and 1/24/13 | Class II | Improperly pasteurized. | Tumalo Farms LLC |
| Devices | LifeStyles ZERO 10 uber-thin lubricated latex condoms. Mfd. for Ansell Healthcare Products LLC, Dothan, AL 96303. A sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). | Zero Regular 10-Ct: SKU# 0-70907-20510-5 Master Case: 30070907205106. | Class II | Out of an abundance of caution, Ansell is implementing a voluntary recall of the Zero Latex Condom (regular) product. The condom has met or exceeded test and quality standards required by the Food and Drug Administration. However, we are experiencing a number of complaints concerning the difficulty in unrolling and subsequent breakage, and so we are asking to have all products returned. | Ansell Healthcare Products LLC |
| Devices | ELECTROLASE HYFRECATOR(R) ELECTRODES - SHARP, REF/Catalog Number 7-100-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED CORPORATION 525 FRENCH RD., UTICA, NY 13502-5994 USA. Intended to be used as active RF electrodes for desiccation, fulguration and coagulation. | Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)]. | Class II | ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. | ConMed Corporation |
| Devices | ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT, REF/Catalog Number 7-101-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED CORPORATION 525 FRENCH RD., UTICA, NY 13502-5994 USA. Intended to be used as active RF electrodes for desiccation, fulguration and coagulation. | Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)]. | Class II | ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. | ConMed Corporation |
| Devices | Maquet ELS Cannula 15 FR. Used for extracorporeal membrane oxygenation (ECMO) for the treatment of respiratory insufficiency in infants. | US Distribution Part number 701017471 Lot numbers 92046825 92065723 92076940 OUS Distribution Part Number Lot Numbers 701002797 92050616 701002797 92052823 701002797 92052913 701002797 92058153 701002797 92063518 701002797 92068260 701002797 92069267 701002797 92072177 701002797 92075413 701002797 92077862 701005092 92081862 701005092 92049129 701005092 92070554 701005093 92049130 701005093 92056899 701005093 92065588 701005093 92069429 701005093 92070553 701005093 92071852 701005093 92073598 701005093 92076875 701017471 92076940 701046644 92063587 701050978 92047882 701050978 92053930 701050978 92054156 701050978 92056171 701050978 92056804 701050978 92065094 701050978 92067382 701050978 92068224 701050978 92069286 701050978 92071806 | Class II | ELS 15 Fr Cannula could potentially contain an occluded arterial lumen. | Maquet Cardiovascular Us Sales, Llc |
| Devices | Animas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infusion Pumps Indicated for continuous subcutaneous infusion of insulin. | All Animas 2020, IR1250 and IR1200 Pump Models - Part Numbers 101370-00, 101371-00, 101372-00, 101374-00, 101375-00, 100380-00, 100381-00, 100382-00, 100384-00, 100385-00, 100450-00, 100210-00, 100211-00, 100212-00, 100250-00, 100251-00, 100252-00, 100200-00, 100201-00, 100202-00, 100170-00, 100171-00 and 100172-00. | Class III | Due to an internal calendar date limit (December 31, 2015) these pumps will cease to operate on January 1, 2016, and will result in a call service alarm that is displayed on the pump display. | Animas Corporation |
| Devices | Varian Eclipse Treatment Planning System for Radiotherapy; Model Number: H48. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye. | H480044 , H481353 , H482733 , H484585 , H485948 , H480045 , H481354 , H482734 , H484634 , H486024 , H480105 , H481433 , H482765 , H484673 , H486032 , H480106 , H481436 , H482827 , H484677 , H486093 , H480159 , H481437 , H482858 , H484680 , H486094 , H480160 , H481451 , H482859 , H484745 , H486095 , H480247 , H481452 , H482860 , H484746 , H486114 , H480301 , H481453 , H482888 , H484747 , H486140 , H480373 , H481454 , H482889 , H484753 , H486209 , H480374 , H481460 , H482897 , H484830 , H486291 , H480378 , H481461 , H483087 , H484842 , H486369 , H480379 , H481462 , H483204 , H484856 , H486385 , H480408 , H481483 , H483345 , H484950 , H486412 , H480409 , H481532 , H483350 , H484951 , H486442 , H480410 , H481533 , H483351 , H48SOOS , H486473 , H480422 , H481581 , H483352 , H485006 , H486486 , H480471 , H481582 , H483353 , H485090 , H486498 , H480477 , H481601 , H483354 , H485091 , H486499 , H480493 , H481627 , H483406 , H485113 , H486543 , H480566 , H481639 , H483442 , H485127 , H486579 , H4806Sl , H481685 , H483452 , H485143 , H486580 , H480692 , H481766 , H483592 , H485144 , H486615 , H480725 , H481781 , H483617 , H485145 , H486616 , H480764 , H481807 , H483666 , H485162 , H486688 , H480765 , H481815 , H483695 , H485244 , H486689 , H480766 , H481834 , H483696 , H485268 , H486694 , H480794 , H481857 , H483698 , H485308 , H486703 , H480808 , H481879 , H483723 , H485321 , H486716 , H480819 , H481923 , H483724 , H485322 , H486759 , H480820 , H481924 , H483725 , H485359 , H486760 , H480821 , H482166 , H483732 , H485442 , H486858 , H480917 , H482167 , H483733 , H485471 , H486859 , H480918 , H482168 , H483757 , H485481 , H486860 , H481054 , H482181 , H483758 , H485536 , H486861 , H481057 , H482182 , H483759 , H485537 , H486885 , H481112 , H482191 , H483767 , H485541 , H486895 , H481114 , H482192 , H483768 , H485557 , H486896 , H481119 , H482193 , H483840 , H485573 , H486938 , H481120 , H482194 , H483841 , H485580 , H486939 , H481133 , H482243 , H483871 , H485581 , H486941 , H481138 , H482244 , H483872 , H485582 , H486957 , H481154 , H482246 , H483943 , H485592 , H487011 , H481155 , H482266 , H483967 , H485595 , H487012 , H481164 , H482267 , H483968 , H485628 , H487277 , H481165 , H482323 , H483969 , H485689 , H487278 , H481166 , H482367 , H483993 , H485694 , H487279 , H481168 , H482385 , H484008 , H485706 , H487302 , H481171 , H482386 , H484023 , H485729 , H487428 , H481172 , H482387 , H484056 , H485776 , H487512 , H481196 , H482388 , H484153 , H485777 , H487513 , H481206 , H482391 , H484154 , H485792 , H487580 , H481207 , H482579 , H484168 , H485800 , H487621 , H481208 , H482580 , H484169 , H485890 , H487639 , H481211 , H482581 , H484274 , H485891 , H487698 , H481218 , H482638 , H484367 , H485892 , H487700 , H487771 , H48A323 , H48B875 , H48C805 , H487772 , H48A398 , H48B887 , H48C806 , H487775 , H48A462 , H48B898 , H48C807 , H487778 , H48A474 , H488899 , H48C808 , H487895 , H48A482 , H48B900 , H48C809 , H487950 , H48AS12 , H48C084 , H48C854 , H487980 , H48AS13 , H48C085 , H48C8SS , H487999 , H48ASSS , H48C086 , H48C866 , H488005 , H48AS87 , H48C116 , H48C881 , H488029 , H48AS90 , H48C120 , H4800Sl , H4880SS , H48AS91 , H48C121 , H480113 , H488102 , H48AS92 , H48C134 , H480118 , H488163 , H48AS93 , H48C135 , H480171 , H488210 , H48AS94 , H48C136 , H48D177 , H488211 , H48AS95 , H48C137 , H48D179 , H488229 , H48A612 , H48C138 , H48D187 , H488237 , H48A614 , H48C173 , H48D211 , H488238 , H48A713 , H48C174 , H48D235 , H488243 , H48A760 , H48C176 , H48D315 , H488249 , H48A762 , H48C212 , H48D316 , H488291 , H48A816 , H48C252 , H48D317 , H488311 , H48A818 , H48C253 , H48D318 , H488312 , H48A890 , H48C278 , H480319 , H488483 , H48A918 , H48C316 , H480320 , H489074 , H48A920 , H48C356 , H480321 , H489079 , H48A956 , H48C367 , H480347 , H489095 , H48A971 , H48C373 , H480349 , H489096 , H48A986 , H48C399 , H480353 , H489114 , H48A987 , H48C434 , H480354 , H489379 , H48B109 , H48C441 , H48D356 , H489417 , H48B138 , H48C442 , H48D394 , H489431 , H488216 , H48C443 , H48D397 , H489432 , H48B2S9 , H48C448 , H48DS17 , H489433 , H48B293 , H48C450 , H48DS24 , H489792 , H48B294 , H48C474 , H48D654 , H489793 , H48B295 , H48C475 , H48D688 , H489794 , H48B331 , H48C476 , H48D689 , H489819 , H48B332 , H48CSS7 , H48D690 , H489953 , H488333 , H48CSS8 , H480758 , H489996 , H48B334 , H48CSS9 , H48D956 , H48A029 , H48B399 , H48CS60 , H480957 , H48A083 , H48B471 , H48CS61 , H48D988 , H48A084 , H48B472 , H48CS75 , H48D992 , H48A085 , H48B480 , H48CS76 , H480993 , H48Al47 , H48BS86 , H48C661 , H48E031 , H48A148 , H48BS87 , H48C688 , H48E069 , H48A149 , H488588 , H48C689 , H48E106 , H48A150 , H48BS89 , H48C715 , H48El39 , H48A202 , H48B602 , H48C717 , H48E143 , H48A224 , H488605 , H48C795 , H48El52 , H48A225 , H488691 , H48C796 , H48El53 , H48A226 , H48B692 , H48C797 , H48E154 , H48A229 , H48B693 , H48C798 , H48El59 , H48A230 , H48B694 , H48C799 , H48E422 , H48A243 , H488787 , H48C800 , H48E423 , H48ES68 , H48F073 , H48FS17 , H48F927 , H48ES90 , H48F074 , H48FS18 , H48F939 , H48ES91 , H48F075 , H48FS19 , H48F944 , H48ES92 , H48F076 , H48FS23 , H48F948 , H48ES93 , H48F077 , H48FS24 , H48F980 , H48ES95 , H48F078 , H48FS34 , H48F993 , H48E609 , H48F079 , H48FS36 , H48F994 , H4BE677 , H48F083 , H4BF537 , H48G020 , H48EB16 , H48F084 , H48FS44 , H48G021 , H48E883 , H4BF085 , H48FS45 , H48G039 , H48E884 , H48F086 , H48FS46 , H48G041 , H48E885 , H48F089 , H48FS47 , H48G109 , H48E888 , H48F120 , H48FS48 , H48Gll7 , H48E890 , H48F131 , H48FS49 , H48G123 , H48E892 , H48F132 , H48FSSO , H48G153 , H48E893 , H48F134 , H48F568 , H48G154 , H48E894 , H48F135 , H48FS92 , H48Gl84 , H48E908 , H48F136 , H48F606 , H48G185 , H48E909 , H48F137 , H48F609 , H48G228 , H48E913 , H48F138 , H48F623 , H48G229 , H48E914 , H4BF156 , H48F624 , H48G230 , H48E915 , H48F166 , H48F637 , H48G235 , H48E916 , H48F167 , H4BF647 , H4BG236 , H4BE917 , H4BF168 , H4BF648 , H48G238 , H4BE918 , H4BF169 , H48F649 , H48G241 , H48E919 , H4BF170 , H48F697 , H48G242 , H48E920 , H48F184 , H48F698 , H48G246 , H48E921 , H48F185 , H48F713 , H48G247 , H4BE922 , H48F194 , H48F714 , H4BG249 , H4BE932 , H48F195 , H48F715 , H4BG250 , H4BE933 , H48F196 , H48F760 , H48G275 , H48E944 , H4BF197 , H48F761 , H48G276 , H48E945 , H48F199 , H48F777 , H48G277 , H4BE946 , H48F219 , H48F779 , H48G278 , H48E947 , H4BF268 , H48F780 , H48G279 , H48E948 , H48F312 , H48F791 , H4BG280 , H48E952 , H48F315 , H48F792 , H48G281 , H48E954 , H48F316 , H48F796 , H48G282 , H48E957 , H48F317 , H4BF824 , H48G283 , H4BE964 , H48F318 , H48FB25 , H48G284 , H48E966 , H4BF331 , H48F826 , H48G285 , H4BE989 , H4BF332 , H48F827 , H48G286 , H48E990 , H48F333 , H48F828 , H48G289 , H48E991 , H4BF354 , H48F829 , H48G290 , H48E992 , H48F394 , H48F835 , H4BG291 , H48E994 , H48F395 , H48F836 , H48G292 , H48E996 , H48F399 , H48F837 , H48G293 , H48F002 , H48F400 , H48F843 , H48G294 , H48F013 , H48F426 , H48F844 , H48G295 , H48F014 , H48F468 , H48FB45 , H48G296 , H48F016 , H48F469 , H48F852 , H48G363 , H4BF017 , H48F470 , H48F854 , H48G405 , H4BF018 , H48F490 , H48FBS6 , H48G413 , H48F025 , H48FS06 , H48F859 , H48G414 , H48F028 , H48FS07 , H48F865 , H48G487 , H481328 , H482681 , H484368 , H485893 , H487736 , H48A244 , H48B816 , H48C801 , H48E425 , H48F029 , H48FS08 , H48F922 , H483654 , H481329 , H482682 , H484435 , H485894 , H487737 , H48A245 , H48B818 , H48C802 , H48ES66 , H48FOS8 , H48FS09 , H48F925 , H48F393 , H481352 , H482732 , H484495 , H485895 , H487739 , H48A246 , H48B819 , H48C803 , H48ES67 , H48F072 , H48F516 , H48F926 , H482411 , H480974 , H48G246 , H480803 , H48B712 , H487089 , H482936 , H48A812 , H487040 , H48F730 , H48G585 , H486116 , H480875 , H482412 , H482384 , H48G247 , H481184 , H480536 , H481835 , H48F478 , H48F246 , H481005 , H48F731 , H48G586 , H48C095 , H480876 , H484904 , H487981 , H487466 , H48E426 , H48A712 , H481836 , H48F479 , H48F443 , H483856 , H48F733 , H48G587 , H48C096 , H48E762 , H48F345 , H487982 , H487782 , H48E427 , H480535 , H48B845 , H480323 , H48F444 , H48G405 , H48C540 , H48G588 , H48C097 , H48E763 , H483697 , H48B252 , H487798 , H48E441 , H484052 , H48F053 , H480324 , H481289 , H481828 , H48C541 , H48G589 , H48C098 , H48E764 , H48F765 , H48F338 , H48G414 , H48E514 , H48F615 , H480971 , H480325 , H481290 , H481829 , H484381 , H48G590 , H48C099 , H48F240 , H487773 , H48F352 , H481315 , H48E517 , H48F617 , H485963 , H486683 , H481291 , H481830 , H488320 , H48G591 , H48C100 , H48F241 , H48G267 , H48F353 , H481316 , H489872 , H48F724 , H482203 , H480262 , H481292 , H481831 , H487595 , H48G592 , H48C101 , H48F326 , H48F355 , H488452 , H481334 , H48F727 , H486934 , H48A254 , H481293 , H480873 , H48F833 , H48GS93 , H48C102 , H48F327 , H482935 , H48A911 , H481335 , H48F729 , H48B366 , H48G584 , H482201 , H480874 , H48F834 , H485100 , H48C103 , H483509 , H485125 , H48C104 , H482381 , H484280 , H480346 , H48A295 , H48B057 , H48G002 , H48E984 , H48F483 , H482383 , H48F942 , H487212 , H48C105 , H486701 , H482164 , H481510 , H48A296 , H48E537 , H48G004 , H48E985 , H48F484 , H483649 , H485896 , H480107 , H48F754 , H48E973 , H486370 , H482289 , H48A184 , H482196 , H48G006 , H48E986 , H483374 , H480830 , H481063 , H480920 , H48F755 , H48E974 , H483506 , H482807 , H480556 , H484018 , H48G007 , H48E987 , H483375 , H483615 , H48A395 , H482793 , H48F756 , H48E975 , H485400 , H487623 , H480557 , H484019 , H484624 , H48E988 , H483376 , H485821 , H48G198 , H480051 , H48F757 , H48E976 , H48B549 , H48E962 , H480558 , H484020 , H480933 , H48F790 , H487866 , H480004 , H481077 , H480052 , H48F758 , H486927 , H483964 , H48E977 , H486581 , H48F526 , H480934 , H48F186 , H487867 , H48F428 , H481078 , H480053 , H484497 , H480692 , H484903 , H48E978 , H48F054 , H480348 , H48F868 , H480530 , H488820 , H48F595 , H482263 , H480054 , H484498 , H480693 , H486069 , H48E979 , H48F059 , H480349 , H481837 , H480055 , H484499 , H488056 , H486071 , H48E980 , H487776 , H482382 , H481838 | Class II | Varian has identified an anomaly with the Eclipse Treatment Planning (for radiotherapy treatments) where the calculation of dose dynamic plans containing different energy fields is incorrect when the Pencil Beam Convolution 11.0 algorithm (PBC 11.0) is used. | Varian Medical Systems, Inc. Oncology Systems |
| Devices | VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Collect LA Product, Item number 450096. Usage: The Safety Blood Collection Set is used in routine venipuncture procedures. | Lot No. 12H27 | Class II | The VACUETTE Safety Blood Collection Set + Luer Adapter may display leaking (small droplets) during use due to a crack on the luer connector piece. | Greiner Bio-One North America, Inc. |
| Devices | Monaco RTP System. Radiation treatment planning. | Versions 3.20.00 and 3.20.01 | Class II | The beam is displayed at the "gantry" angle, but the dose is calculated at the "rotation_start" angle. | Elekta, Inc. |
| Devices | MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination between patients. | Catalog number AVA 500 HCS/3010903 - Lot numbers D72211, DA82711, DA93131, D101091, D101681, D110591, D111961, D113341A, D120731, D101641, D82741, D93131, DA101091, DA101691, D110601, D111991, D113351, D120831A, D72251, D83011, D93151, D101101, D101701, D110611, D112061, D113351A, D120741, D72261, DA83021, DA93151, DA101101, DA101721, D110621, D112131, D113461, D120761, D72281, DA83031, DA93221, D101111, D101721, D110631, D112131A, D113461A, D120771, D72291, D83041, D93231, DA101111, D101731, D110661, D112341, D113471, D120831, D72651, DA83121, D93411, D101121, D101741, D110731, D112341A, D113471A, D120861, D72671, D83151, DA93411, DA101121, D101861, D110741, D112351, D113491, DA72681, D83651, D93421, D101131, DA101861, D110751, D112351A, D113501, DA72691, D90021, DA93421, DA101131, D101881, D110871, D112361, D120161, D72751, D90541, D93431, D101171, DA101881, D110881, D112361A, D120161A, D120891, D90561, DA93431, D101301, DA101901, D110901, D112411, D120171, D80221, D90611, D93561, D101311, D101911, D111201, D112411A, D120171A, DA80231, DA90631, D93631, DA101441, DA101931, D111221, D112421, D120181, DA80241, D90821, DA93631, D101441, D101931, D111231, D112421A, D120311, D80281, DA90831, DA100141, D101461, D101951, D111241, D112431, D120311A, D80391, D90981, D100151, DA101461, DA101951, D111261, D112431A, D120321, DA80561, D91031, D100181, D101471, D101971, D111261A, D112441, D120321A, D80631, DA91041, DA100191, DA101481, D102111, D111291, D112441A, D120331, DA80641, DA91061, DA100321, D101481, D102141, D111291A, D112481, D120341, D80871, D91071, D100331, DA101511, DA102141, D111301, D112481A, D120371, D80981, D91181, DA100341, D101511, D102151, D111301A, D112491, D120371A, DA81281, D91191, D100351, D101531, DA102151, D111311, D112501, D120381, DA81421, D91281, DA100461, DA101531, D102351, D111311A, D112621, D120381A, D81471, D91331, D100561, D101541, DA102351, D111321, D112621A, D120391, D81541, D91351, D100671, D101551, D102811, D111321A, D112631, D120451, DA81821, D91381, DA100671, DA101551, D102821, D111361, D112631A, D120511, D81971, D91561, DA100691, D101581, D102921, D120861A, D112641, D120521, D81991, D91901, D100691, DA101581, D103361, D111351, D112721, D120521A, DA82031, D92061, D100711, D101591, D103401, D111371, D112791, D120531, D82131, D92091, DA100711, DA101601, D103481, D111371A, D113071, D120541, D82141, D92111, DA100741, D101601, D103631, D111381, D113081, D120541A, D82171, D120881, D100751, D101611, D103611, D111711, D113111, D120551, D82181, D92501, D101021, D101621, D103571, D111721, D113111A, D120591, D82191, D92521, DA101021, DA101621, D103621, D111731, D113291, D120601, DA82201, DA92781, D101031, D101631, D110181, D111751, D113291A, D120671, D120881A, D92791, D101041, D101651, D110191, D111861, D113321, D120671A, D82241, D93081, DA101041, DA101651, D110321, D111871, D113321A, D120681, DA82251, D93091, D101061, D101661, D110331, D111891, D113331, D120681A, D82671, D93101, DA101061, D101671, D110351, D111921, D113331A, D120691, D82701, D93111, D101071, DA101671, D110541, D111921A, D113341, and D120721. | Class II | Bayer is initiating this recall because in certain packages within the affected lots, the seal between the white polyethylene and the clear plastic may be missing on the Hand Controller Sheath package, resulting in a potential breach of the sterility of this accessory. | Medrad Inc |
| Food/Cosmetics | Lean Cuisine Culinary Collection Mushroom Mezzaluna Ravioli ravioli filled with portobello & button mushrooms, romano & ricotta cheeses in a creamy marsala wine sauce with spinach & red peppers no preservatives, NET WT 8 5/8 oz (244g) 0 13800 58358 1 DISTRIBUTED BY: NESTLE' USA, INC., SOLON, OH 44139 | Lot 2311587812 Best Before Dec2013 and Lot 2312587812 Best Before Dec2013, UPC Code 13800-58358 | Class II | The firm received complaints of small fragments of glass that were found inside the ravioli portion of the entrée. | Nestle USA |
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