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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 66646
Product Type Biologics
Status Terminated
Recalling Firm OneBlood, Inc.
City St Petersburg
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-10-04
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 W03941345371800 (2 units) Class II Blood products, which were labeled as leukoreduced, but exceeded the acceptable limit for white blood cell count, were distributed. 2 units B-0211-14