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U.S. Department of Health and Human Services

Enforcement Report - Week of June 12, 2013

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Event Detail

Event ID 64516
Product Type Biologics
Status Terminated
Recalling Firm OneBlood / dba CBCF
City Lauderhill
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-18
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
Blood and Blood Products for Reprocessing W036812599383; Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. 1 B-1351-13
Red Blood Cells Leukocytes Reduced W036812599383; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. 1 B-1352-13
Red Blood Cells W036812566971; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. 1 B-1353-13
Platelets Pooled Leukocytes Reduced W036812843768; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. 1 B-1354-13
Fresh Frozen Plasma W036812566971; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. 1 B-1355-13
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