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U.S. Department of Health and Human Services

Enforcement Report - Week of August 28, 2013

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Event Detail

Event ID 65220
Product Type Biologics
Status Terminated
Recalling Firm Community Blood Centers of South Florida, Inc.
City Hialeah
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-04
Initial Firm Notification of
Consignee or Public
FAX
Distribution Pattern Michigan; Florida

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Red Blood Cells W036812440893; W036811187949; W036811102262; Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. 3 B-2104-13
Platelets Pooled Leukocytes Reduced W036812843172; W036811804772; Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. 2 B-2105-13
Fresh Frozen Plasma W036812440893; W036811187949; W036811102262; Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. 3 B-2106-13
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