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U.S. Department of Health and Human Services

Enforcement Report - Week of October 2, 2013

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Event Detail

Event ID 65530
Product Type Biologics
Status Terminated
Recalling Firm OneBlood, Inc.
City Hialeah
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-04
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Switzerland; FL

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Red Blood Cells W036809267543 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. 1 unit B-2248-13
Platelets Pooled Leukocytes Reduced W036809818928 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. 1 unit B-2249-13
Blood and Blood Products for Reprocessing W036809267543 Class III Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. 1 unit B-2250-13
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