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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
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
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
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
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
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
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