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U.S. Department of Health and Human Services

Enforcement Report - Week of June 19, 2013

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Event Detail

Event ID 43953
Product Type Biologics
Status Terminated
Recalling Firm Community Blood Centers of South Florida, Inc.
City Lauderhill
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2006-12-21
Initial Firm Notification of
Consignee or Public
Distribution Pattern Florida

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Platelets Pheresis Leukocytes Reduced 2238974(Part A); 2238974(Part B); 2238974(Part C) Class II Blood products, which were labeled as leukoreduced, but were not tested to verify the White Blood Cell count, were distributed. 3 units B-1389-13