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U.S. Department of Health and Human Services

Enforcement Report - Week of December 11, 2013

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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

Product Detail

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