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U.S. Department of Health and Human Services

Enforcement Report - Week of April 3, 2013

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Event Detail

Event ID 54946
Product Type Biologics
Status Terminated
Recalling Firm Blood Systems, Inc
City Billings
State MT
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2010-01-08
Initial Firm Notification of
Consignee or Public
FAX
Distribution Pattern CA, MT, WY, MS, CO, SD, TX, NV, AR

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Red Blood Cells (Apheresis) W042309063726004 , W042309063726004 , W04230906376600P , W04230906376600P , W04230906379500F , W04230906379500F. Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 6 components B-0668-13
Red Blood Cells Leukocytes Reduced Irradiated W042309061251000, W04230906126200V, W04230906324900U. Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 3 components B-0667-13
Fresh Frozen Plasma W04230900860500N , W042309010963001 , W04230901112000Y , W04230901181100H , W04230901351700Y , W042309041019006 , W04230904319800A , W04230904454800J , W04230904455800F , W04230904456700D , W04230904800700D , W04230905001700V , W04230905059700X , W04230905198500U , W04230905314800Z , W042309054782004 , W04230905502400R , W04230905944900O , W04230905956800A , W04230906003700S , W04230906191700M , W04230906195000K , W04230906212400Z , W04230906239800K , W04230906281100Q , W04230906281400K , 234630646, 234630655, 234631087, W042308037694000, W04230905140900K, W04230803972800H , W04230804145300O , W04230804145500K , W04230804265000Z , W04230900657700V , W04230900762300Z , W04230900764300R , W04230900764800H , W04230900772500N , W04230900862100N , W042309008799008 , W04230901010200H , W042309010106009 , W042309010122009 , W042309010446006 , W04230901049900H , W04230901065800J , W042309010689005 , W042309010971001 , W04230901180300H , W042309011808007 , W042309011817005 , W04230901182200B , W042309011826003 , W04230901186500Q , W04230901188800C , W04230901189400G , W042309011912007 , W04230901191700Y , W04230901376900V , W04230901377800T , W04230901378400X , W04230903900500X , W04230903945800C , W04230903946500E , W04230904021200K , W04230904034300Z , W04230904035700N , W04230904035900J , W04230904036400P , W04230904037800D , W04230904072300B , W04230904212400P , W042309042149007 , W04230904236300W , W04230904238900C , W04230904263000Q , W04230904270000U , W04230904317100W , W04230904318700G , W04230904318900C , W04230904319200M , W04230904319700C , W04230904324600Q , W04230904326200Q , W04230904356600V , W04230904357400V , W04230904392000R , W04230904393100L , W04230904396900U , W04230904452700T , W04230904452900P , W04230904453500T , W04230904453800N , W04230904454000Z , W04230904455100T , W042309045064006 , W04230904511000Q , W042309045152006 , W042309045161004 , W042309045163000 , W04230904517400V , W04230904518100X , W04230904520000M , W042309045304006 , W04230904663400S , W04230904680400O , W04230904680700I , W04230904683300E , W042309046837006 , W04230904686800T , W04230904794900B , W04230904795300J , W04230904797300B , W04230905034900S , W04230905150000U , W042309051650002 , W04230905242200A , W042309053151008 , W04230905316600V , W04230905317400V , W04230905317900L , W04230905318500P , W04230905319900D , W04230905424700D , W04230905478600X , W04230905487400X , W042309055003000 , W04230905501500T , W04230905501900L , W04230905502200V , W04230905502800J , W04230905504000R , W04230905536700I , W04230905545900A , W04230905546100M , W042309057003005 , W04230905847700W , W04230905854100B , W04230905855900S , W04230905857700O , W04230905869300G , W04230905948300K , W04230905954900G , W04230905955400M , W04230905956300K , W04230905957300G , W042309059577008 , W042309059597000 , W04230906040300G , W042309061251000 , W04230906133700P , W042309061967002 , 234624664, 234624671, 234624727, 234628182, 234628831, 234633409, W04230803796000X, W04230803920900Q, W04230803982200L. Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 163 components B-0666-13
Blood and Blood Products for Reprocessing W04230804145700G , W04230804146600E , W042308041469008 , W04230804264200Z , W04230804265700L , W04230804270900T , W04230804271400Z , W042308042794003 , W04230804287800W , W042308042880007 , W042308042890003 , W04230804289800O , W04230900651700I , W04230900652100Q , W042309006538008 , W042309006562008 , W042309006570008 , W04230900658300Z , W04230900658400X , W04230900659300V , W04230900735000G , W04230900739700N , W04230900740100Q , W04230900762700R , W04230900771200X , W04230900774000P , W042309007748009 , W04230900775100J , W04230900819800L , W04230900831200C , W04230900832100A , W042309008325002 , W042309008332004 , W04230900833800T , W042309008340004 , W042309008341002 , W04230900834700R , W042309008350000 , W04230900835600P , W04230900835800L , W042309008412004 , W04230900860200T , W04230900860900F , W04230900861200P , W04230900861800D , W04230900862500F , W042309008628009 , W042309008840001 , W04230900886300O , W04230900887200M , W042309008887008 , W042309009125002 , W04230900912800X , W04230900915200X , W04230900915800L , W04230900916300R , W042309010051007 , W04230901006800Q , W04230901009000U , W04230901009600I , W042309010126001 , W042309010133003 , W042309010140005 , W04230901014600U , W042309010230001 , W04230901044300C , W04230901045100C , W042309010457000 , W042309010462006 , W04230901046900T , W042309010470006 , W042309010480002 , W04230901050700C , W04230901051100K , W04230901051500C , W042309010528002 , W04230901053100C , W042309010537000 , W042309010543004 , W042309010552002 , W042309010560002 , W04230901056600R , W04230901058800F , W04230901059800B , W04230901064700P , W04230901065000Z , W04230901066100T , W04230901068100L , W04230901094800* , W04230901094900Y , W042309010960007 , W042309010961005 , W04230901096500Y , W04230901096700U , W04230901096900Q , W042309011086006 , W042309011087004 , W04230901109800Z , W04230901110300* , W042309011110001 , W04230901111300W , W04230901112300S , W04230901171100P , W04230901171500H , W04230901172000N , W04230901172600B , W04230901173200F , W04230901180500D , W042309011819001 , W042309011833005 , W04230901183800W , W042309011841005 , W04230901185800O , W04230901186200W , W042309011911009 , W04230901191900U , W04230901194600O , W04230901195500M , W04230901196300M , W04230901196800C , W04230901197400G , W04230901197700A , W04230901199000G , W042309011996004 , W04230901200200U , W04230901211000M , W04230901211400E , W04230901211600A , W042309012119004 , W04230901212100G , W042309012535009 , W042309012538003 , W042309012545005 , W042309012555001 , W04230901256800S , W04230901348500I , W04230901349200K , W042309013498008 , W042309013505005 , W04230901351600* , W04230901352400* , W04230901352600W , W04230901379100Z , W04230901382300E , W04230901383300A , W042309013861002 , W04230901386900N , W042309037208006 , W04230903730800Z , W042309037315000 , W042309039002002 , W042309039003000 , W04230903935200W , W04230903936700I , W04230903945400K , W04230903945900A , W04230903946300I , W04230903947000K , W04230903948200C , W042309039484008 , W042309039486004 , W04230903987000P , W04230903987500F , W04230903989200D , W04230904027700N , W042309040330008 , W04230904033700V , W04230904037300N , W042309040388009 , W04230904048200D , W042309040495003 , W042309040501002 , W04230904051700N , W04230904070400H , W042309040719003 , W042309040727003 , W04230904073000D , W04230904102300E , W042309041027006 , W04230904104000C , W04230904104900V , W04230904107700N , W04230904108800H , W04230904109300N , W04230904109800D , W04230904110100I , W042309041107006 , W04230904111100E , W04230904171600U , W04230904175300K , W042309041769004 , W042309041779000 , W042309041785004 , W042309041794002 , W042309041800001 , W04230904211900J , W04230904212800H , W04230904213100R , W04230904215300F , W042309042157007 , W04230904221100R , W04230904221400L , W04230904221800D , W042309042229007 , W04230904223500B , W042309042245007 , W042309042255003 , W042309042272001 , W04230904227900O , W04230904230200L , W04230904230700B , W042309042340009 , W04230904234600Y , W042309042350005 , W04230904235300* , W042309042360001 , W04230904237200U , W04230904237600M , W04230904250900S , W04230904251700S , W04230904252400U , W04230904252900K , W04230904253400Q , W04230904254000U , W04230904262300O , W04230904264600A , W04230904266000E , W042309042666002 , W042309042671008 , W04230904267700X , W042309042680006 , W04230904311100J , W042309043118005 , W04230904312300B , W042309043128001 , W042309043132009 , W042309043135003 , W04230904316900K , W04230904317400Q , W04230904325000Y , W04230904326500K , W04230904352400E , W042309043528006 , W04230904353400A , W042309043553004 , W042309043891005 , W04230904389400* , W04230904390400R , W04230904394100H , W042309043945009 , W042309043949001 , W042309043955005 , W04230904454200V , W04230904455300P , W04230904456000R , W04230904456200N , W042309044595005 , W04230904459800* , W042309045067000 , W042309045071008 , W042309045080006 , W04230904508800R , W04230904509300X , W04230904509700P , W04230904510200Q , W04230904514200A , W042309045144006 , W042309045147000 , W042309045171000 , W04230904517500T , W04230904518500P , W04230904519000V , W04230904519300P , W04230904532500X , W04230904537000N , W04230904537400F , W042309045385009 , W04230904543400N , W04230904544500H , W04230904564900U , W04230904565900Q , W042309045661001 , W04230904609100L , W04230904610000E , W042309046107000 , W04230904612500X , W04230904613700P , W04230904615200R , W04230904615900D , W04230904616700D , W04230904617000N , W04230904617400F , W042309046177009 , W042309046179005 , W04230904647300U , W04230904648200S , W04230904648900E , W04230904649700E , W04230904662300Y , W04230904662800O , W04230904663800K , W04230904664500M , W042309046862004 , W04230904688200X , W04230904690100M , W04230904692100E , W042309046925006 , W04230904694700V , W04230904695600T , W04230904697900F , W042309047000006 , W04230904705000N , W04230904707000F , W04230904711900D , W042309047137009 , W04230904764200C , W042309047644008 , W042309047646004 , W042309047647002 , W04230904764900Z , W04230904765100A , W042309047661006 , W042309047663002 , W04230904766800T , W04230904784700N , W04230904785500N , W04230904786400L , W04230904787400H , W042309047897003 , W04230904789900* , W04230904790600X , W04230904796000L , W04230904798100B , W04230904801200J , W04230904801600B , W042309048028003 , W042309048033009 , W042309048037001 , W042309048044003 , W04230904804800W , W042309048203005 , W042309048205001 , W04230904820700Y , W04230904820900U , W042309048211005 , W04230904821700U , W04230904864600P , W04230904865300R , W04230904865600L , W04230904866400L , W04230904866800D , W04230904867300J , W042309048678009 , W04230904897400U , W04230904897900K , W042309049406004 , W04230904941100A , W042309049414004 , W042309050012004 , W042309050022000 , W042309050086005 , W04230905009000D , W042309050094005 , W042309050100004 , W04230905012100V , W04230905012800H , W04230905013800D , W04230905014500F , W042309050156009 , W042309050165007 , W04230905017100B , W04230905020100V , W04230905020400P , W04230905021200P , W04230905021800D , W042309050327003 , W04230905032900* , W04230905033100B , W042309050333007 , W042309050336001 , W04230905033700* , W042309050340009 , W042309050342005 , W04230905041000D , W04230905054000U , W04230905054800E , W042309051056001 , W042309051062005 , W04230905106500* , W04230905106700W , W04230905140600Q , W04230905143300K , W04230905144200I , W04230905147700X , W04230905167600J , W04230905168100P , W042309051699005 , W042309051703008 , W04230905190300T , W04230905190700L , W04230905191000V , W042309051949001 , W04230905195800* , W04230905196600* , W042309051971005 , W04230905197600W , W04230905198700Q , W04230905198900M , W042309052409004 , W04230905241400A , W042309052417004 , W042309052418002 , W042309052427000 , W04230905301500O , W04230905301900G , W04230905313100G , W042309053139000 , W042309053143008 , W04230905315800V , W042309053161004 , W04230905316400Z , W042309053171000 , W04230905317700P , W04230905318900H , W04230905319300P , W04230905320000M , W04230905324600V , W04230905327100T , W04230905327700H , W04230905327900D , W04230905330200A , W04230905331900T , W042309053330002 , W04230905333600R , W04230905337300H , W04230905337600B , W04230905357700U , W042309053580003 , W04230905358500U , W04230905359600O , W042309054450007 , W04230905445900Q , W04230905446600S , W04230905457700E , W04230905479300Z , W04230905484100E , W04230905484900Z , W042309054855002 , W04230905500900P , W04230905503000V , W04230905503400N , W04230905506400B , W042309055077001 , W04230905513300H , W042309055139005 , W04230905519100Y , W04230905519400S , W04230905519700M , W04230905537500I , W04230905543100Y , W04230905543400S , W04230905543800K , W04230905546600C , W04230905546700A , W042309055804008 , W042309055807002 , W04230905584800L , W04230905585500N , W04230905586300N , W042309056053001 , W042309056061001 , W04230905608300Q , W04230905609000S , W04230905609600G , W04230905610100H , W042309056105009 , W042309056109001 , W042309056113009 , W042309056116003 , W04230905611900Y , W04230905614600S , W04230905617300M , W04230905619400C , W04230905632400O , W04230905632600K , W04230905640300Q , W04230905641900A , W04230905642400G , W042309056428008 , W04230905643300E , W04230905643500A , W04230905644000G , W04230905659600D , W042309057013001 , W04230905752500R , W04230905753400P , W04230905754500J , W04230905762900B , W04230905763200L , W04230905763300J , W042309057639007 , W042309057648005 , W04230905765300B , W04230905767800U , W04230905769100* , W04230905769700O , W04230905770500J , W04230905774000D , W042309057754001 , W04230905778200U , W042309057809003 , W042309057833003 , W04230905783900S , W04230905784400Y , W042309057921003 , W04230905806700V , W04230905806800T , W04230905807700R , W04230905808100Z , W04230905808400T , W04230905810400G , W04230905810700A , W04230905811100I , W04230905811500A , W042309058118004 , W04230905812000G , W04230905840300V , W04230905841200T , W04230905842200P , W042309058462009 , W042309058472005 , W04230905850000T , W042309058551007 , W042309058561003 , W04230905856700S , W04230905857400U , W04230905859400M , W04230905859600I , W04230905859900C , W04230905868200M , W04230905870000D , W04230905870700* , W04230905871600Y , W042309059020008 , W04230905903800P , W04230905904300V , W04230905905000X , W042309059407007 , W042309059415007 , W042309059417003 , W04230905941900* , W04230905944400Y , W04230905947500K , W04230905947700G , W04230905948100O , W04230905948600E , W042309059513003 , W04230905978900L , W04230905982400A , W042309059836002 , W04230905983900X , W042309059844002 , W04230905986400V , W04230905986800N , W04230905995000Z , W04230905995600N , W04230905996100T , W04230905996600J , W042309060007003 , W042309060016001 , W042309060022005 , W04230906002700W , W04230906005000Y , W04230906005400Q , W04230906061500T , W04230906062500P , W04230906063400N , W04230906064200N , W04230906064500H , W04230906064800B , W04230906065600B , W042309060659005 , W04230906066200F , W042309060667005 , W042309060669001 , W04230906074300D , W042309060747005 , W042309061231008 , W04230906124500X , W04230906125600R , W04230906133400V , W042309061393009 , W04230906204700T , W042309062051000 , W04230906206400R , W04230906213500T , W04230906217200J , W04230906218000J , W04230906320100P , W04230906320500H , W042309063209009 , W042309063228003 , W04230906323000F , W04230906324900U , W04230906347200G , W042309063476008 , W04230906365900V , W04230904222400H , W04230904225000D , W04230904567000*. Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 610 components B-0665-13
Cryoprecipitated AHF W04230903945900A, W042309041794002, W04230904353400A, W042309048028003, W042309048037001, W04230905009000D, W04230905054000U, W04230905457700E, W04230905753400P, W042309057809003, W042309057833003, W042309062051000, W04230906206400R, W04230906215500L, W04230900651700I, W04230900652100Q, W042309006538008, W042309006562008, W042309006570008, W04230900658300Z, W04230900658400X, W04230900740100Q, W042309011086006, W042309011087004, W04230901109800Z, W042309012535009, W042309012538003, W042309012545005, W04230901256800S, W04230901348500I, W04230901349200K, W042309013498008, W042309013505005, W04230901351600*, W04230903946300I, W04230903947000K, W04230903948200C, W042309039484008, W042309039486004, W04230903987000P, W04230903987500F, W04230903989200D, W04230904070400H, W04230904171600U, W04230904175300K, W042309041769004, W042309041779000, W042309041785004 , W042309041800001, W04230904251700S, W04230904252400U, W04230904252900K, W04230904254000U, W04230904352400E, W042309043528006, W042309043553004, W04230904543400N, W04230904609100L, W04230904610000E, W042309046107000, W04230904612500X, W04230904613700P, W04230904615200R, W04230904615900D, W04230904616700D, W04230904617000N, W04230904617400F, W042309046177009, W042309046179005, W04230904705000N, W04230904707000F, W04230904711900D, W04230904784700N, W04230904785500N, W04230904786400L, W04230904787400H, W042309047897003, W04230904789900* , W04230904801200J, W04230904801600B, W042309048033009, W042309048044003, W04230904804800W, W04230904864600P, W04230904865300R, W042309050012004, W042309050086005, W042309050094005, W042309050100004, W04230905014500F, W042309050156009, W042309050165007, W04230905017100B, W04230905054800E, W04230905140600Q, W04230905144200I, W04230905147700X, W042309054450007, W04230905445900Q, W04230905484100E, W04230905484900Z, W042309054855002, W04230905585500N, W04230905586300N, W04230905631400S, W04230905632400O, W04230905632600K, W04230905752500R, W042309057921003, W042309063567002, W042309063572008, W04230906357900V. Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.. 112 components B-0664-13
Red Blood Cells Leukocytes Reduced W04230903733800N, W04230903734700L, W04230903735000V, W042309037369009, W04230903738000J, W04230903794300I, W04230903795000K, W042309037956008, W042309037967002, W04230903797000C, W042309037975002, W04230903797800X, W042309037980008, W04230903803600Z, W04230906124500X, W04230906125600R, W04230906126600N, W04230906139800*, W04230906339100I, W04230906347200G, W042309063476008, W04230906377900F, W042309037231008, W04230903730800Z, W042309037315000, W042309037331000, W04230903803000A, W04230905301900G, W04230906074300D, W042309060747005, W04230906075200B, W042309061231008, W04230906133400V, W04230906133700P, W042309061386007, W042309061393009, W04230906191700M, W04230906195000K, W042309061967002, W04230906197900V, W04230906239800K, W04230906281100Q, W04230906281400K, W04230906320100P, W04230906320500H, W042309063228003, W04230906365900V. Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.. 47 components B-0663-13
Red Blood Cells (Apheresis) Leukocytes Reduced W042309037311008 , W042309037311008 , W04230903736500H , W04230903736500H , W042309060749001 , W042309063237001 , W042309060749001 , W042309061224006 , W042309061224006 , W04230906193800C , W04230906193800C , W04230906239600O , W04230906280300Q , W042309063237001 , W04230906345900A , W04230906357100A. Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 16 components B-0662-13
Plasma Frozen Cryoprecipitate Reduced W04230905631400S Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 1 component B-0661-13
Fresh Frozen Plasma (Apheresis) W042309011078006 , W04230904071300F , W04230904071300F , W042309041704001 , W04230904174600I , W04230904174600I , W04230904800400J , W04230905584300V , W04230905585900F , W042309062042002 , W042309062042002 , W04230906210100C , W04230906210100C , W04230906212900P , W04230800018300W, W04230800331700P, W04230803557400B, W04230803557400B, W04230803982000P, W042308042036005, W04230804206600U, , W04230804291100P , W04230804291100P , W04230900650400S , W04230901022300* , W04230901022300* , W04230901022300* , W04230901348900A , W04230901348900A , W042309041704001 , W042309041704001 , W04230904174600I , W042309043546002 , W04230904452400Z , W04230904452400Z , W04230904543200R , W04230904543200R , W04230904565800S , W04230904565800S , W04230904567400S , W04230904567400S , W04230904711400N , W04230904711400N , W04230904800400J , W042309048035005 , W042309048035005 , W04230904865200T , W04230904866100R , W04230904866100R , W04230904866100R , W042309050078005 , W042309050078005 , W04230905140700O , W04230905140700O , W04230905144000M , W042309051474002 , W042309051474002 , W04230905148700T , W04230905444800W , W04230905584300V , W04230905585900F , W04230905585900F , W04230905585900F , W04230905587200L , W04230905587200L , W04230905587200L , W04230905782800Y , W04230905782800Y , W04230905977600V , W04230905977600V , W04230906209200J , W04230906209200J , 234625823, 234630647, 234630647, 234630647, 234631073, 234631073, 234631073, 234634505, 234634505, W04230800174500H, W04230800175100L, W04230800175100L, W04230800330400Z, W04230800330400Z, W04230800330400Z, W04230800331700P, W04230800331700P, W04230800643900V, W04230800418900U, W042308035495009, W042308039374000, W04230803982000P, W042308042036005, W04230804206600U. Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 96 components B-0670-13
Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated W04230906345300M , W04230906239600O , W04230906345600G. Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 3 components B-0669-13
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