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U.S. Department of Health and Human Services

Enforcement Report - Week of May 8, 2013

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Event Detail

Event ID 64166
Product Type Biologics
Status Terminated
Recalling Firm OneBlood, Inc.
City Lauderhill
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-16
Initial Firm Notification of
Consignee or Public
Telephone
Distribution Pattern Swaziland; Florida; New York

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Red Blood Cells W036809308115; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. 1 B-1066-13
Platelets Pooled Leukocytes Reduced W036809816399; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. 1 B-1067-13
Cryoprecipitated AHF W036809819156; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. 1 B-1068-13
Blood and Blood Products for Reprocessing W036809308115; Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. 1 B-1069-13
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