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U.S. Department of Health and Human Services

Enforcement Report - Week of December 11, 2013

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Product Detail

Product Description Red Blood Cells (Apheresis) Leukocytes Reduced
Recall Number B-0005-14
Classification Class II
Code Info 2251295 (2 units)
Product Distributed Qty 2 units
Reason For Recall Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.

Event Detail

Event Id 66216
Product Type Biologics
Status Terminated
Recalling Firm OneBlood, Inc.
City Hialeah
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-09
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern Florida
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