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U.S. Department of Health and Human Services

Enforcement Report - Week of February 6, 2013

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Event Detail

Event ID 45117
Product Type Biologics
Status Terminated
Recalling Firm American National Red Cross (The)
City Saint Louis
State MO
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2007-08-07
Initial Firm Notification of
Consignee or Public
Distribution Pattern MO

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Platelets Pheresis Leukocytes Reduced 011LT11137, 011LT11139 (2 units), 011LT11140, 011LT11141 (2 units), 011LT11142, 011LT11143 (2 units), 011LT11145, 011LT11146 (2 units), 011LT11148 Class II Blood products, which were labeled as leukoreduced, but were not tested to verify white blood cell count, were distributed. 13 units B-0251-13