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U.S. Department of Health and Human Services

Enforcement Report - Week of December 26, 2013

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Event Detail

Event ID 66643
Product Type Biologics
Status Terminated
Recalling Firm American National Red Cross
City Columbus
State OH
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-09-01
Initial Firm Notification of
Consignee or Public
Distribution Pattern MI, OH

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Red Blood Cells Leukocytes Reduced W201613002140; W201613002141; W201613002143; W201613002148; W201613002151; W201613002154; W201613002627; W201613002629; W201613002631; W201613002633; W201613002636 Class III Blood products, in which leukoreduced filtering was conducted beyond the allowable time limits, were distributed. 11 units B-0251-14