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U.S. Department of Health and Human Services

Enforcement Report - Week of December 26, 2013

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Product Detail

Product Description Platelets Pheresis Leukocytes Reduced
Recall Number B-0211-14
Classification Class II
Code Info W03941345371800 (2 units)
Product Distributed Qty 2 units
Reason For Recall Blood products, which were labeled as leukoreduced, but exceeded the acceptable limit for white blood cell count, were distributed.

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 FAX
Distribution Pattern Florida
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