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U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

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Product Detail

Product Description Cryoprecipitated AHF, Pooled
Recall Number B-0968-13
Classification Class II
Code Info 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
Product Distributed Qty 115
Reason For Recall Cryoprecipitated AHF, which failed to meet the minimum potency of 80IU of AHF (Factor VIII), was distributed.

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
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