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U.S. Department of Health and Human Services

Enforcement Report - Week of April 17, 2013

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Product Detail

Product Description Cryoprecipitated AHF
Recall Number B-0997-13
Classification Class III
Code Info 012X44022, 012X44024, 012X44013, 012X44016, 012X43541, 012X44006, 012GY07319, 012X43532, 012GY07315, 012GY07317, 012G07304, 012GY07310, 012E85978, 012FL38709, 012E85972, 012E85975, 012E85970, 012E85971, 012X44018, 012X44021, 012GY07303, 012GY07305, 012FL38043, 012GY07152, 012C82302, 012E85969, 012C82288, 012C82293, 012GY07322, 012K30342, 012K30354, 012K30356, 012K30362, 012K30364, 012L65504
Product Distributed Qty 35 units
Reason For Recall Blood products, for which shipping and storage conditions were undocumented, were distributed.

Event Detail

Event Id 46980
Product Type Biologics
Status Terminated
Recalling Firm The American National Red Cross South Carolina Region
City Columbia
State SC
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2007-11-14
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern GA, SC