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U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

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Event Detail

Event ID 64208
Product Type Biologics
Status Terminated
Recalling Firm American Red Cross Blood Services Heart of America Region
City Peoria
State IL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-12-05
Initial Firm Notification of
Consignee or Public
Telephone
Distribution Pattern Illinois, Oklahoma

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Cryoprecipitated AHF 40FC25610; 40FL47750; 40FL47755; 40GG25279; 40GT74300; 40GZ46302; 40K08469; 40LM12864; 40LT59262; 40LT59302; 40LT59322; 40LT59338; 40LX27007; 40LX27012; 40LZ36145 Class II Cryoprecipitated AHF, which failed to meet the minimum potency of 80IU of AHF (Factor VIII), was distributed. 15 B-0969-13
Cryoprecipitated AHF, Pooled 22638; 22639; 22640; 22641; 22642; 22643; 22644; 22645; 22599; 22600; 22601; 22604; 22605; 22606; 22607; 22608; 22609; 22610; 22611; 22612; 22614; 22615; 22616; 22617; 22618; 22619; 22620; 22621; 22622; 22624; 22625; 22626; 22627; 22628; 22629; 22630; 22631; 22632; 22633; 22634; 22635; 22636; 22637; 22729; 22648; 22649; 22650; 22651; 22652; 22653; 22716; 22718; 22731; 22654; 22655; 22656; 22657; 22658; 22659; 22660; 22661; 22662; 22663; 22664; 22665; 22666; 22667; 22668; 22669; 22670; 22671; 22675; 22678; 22680; 22681; 22682; 22683; 22684; 22686; 22687; 22688; 22689; 22690; 22691; 22692; 22693; 22694; 22695; 22696; 22697; 22701; 22714; 22715; 22719; 22720; 22721; 22724; 22726; 22727; 22728; 22735; 22737; 22750; 22752; 22754; 22763; 22764; 22768; 22771; 22776; 22777; 22779; 22780; 22781; 22782 Class II Cryoprecipitated AHF, which failed to meet the minimum potency of 80IU of AHF (Factor VIII), was distributed. 115 B-0968-13
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