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U.S. Department of Health and Human Services

Enforcement Report - Week of March 13, 2013

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Event Detail

Event ID 63592
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 2012-09-20
Initial Firm Notification of
Consignee or Public
FAX
Distribution Pattern Switzerland and FL

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Red Blood Cells Leukocytes Reduced W036811258578 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 1 unit B-0474-13
Blood and Blood Products for Reprocessing W036811258578; W036810173369 Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 2 units B-0475-13
Red Blood Cells W036810173369 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 1 unit B-0476-13
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