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U.S. Department of Health and Human Services

Enforcement Report - Week of July 11, 2012

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Event Detail

Event ID 46033
Product Type Biologics
Status Terminated
Recalling Firm American National Red Cross (The)
City Omaha
State NE
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2007-09-28
Initial Firm Notification of
Consignee or Public
Distribution Pattern Omaha, NE

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Platelets Pheresis Leukocytes Reduced 09GZ09998; 09GZ10010; 09GZ10011 Class II Blood products, which were labeled as leukoreduced, but did not have leukoreduction testing completed were distributed. 3 units B-1755-12