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U.S. Department of Health and Human Services

Enforcement Report - Week of November 7, 2012

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Event Detail

Event ID 62531
Product Type Biologics
Status Terminated
Recalling Firm Central Blood Bank
City Pittsburgh
State PA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-25
Initial Firm Notification of
Consignee or Public
Telephone
Distribution Pattern Pennsylvania; Florida

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Platelets W085812002035; W087011013731; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. 2 B-2467-12
Fresh Frozen Plasma W085812002035; W087011013731; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. 2 B-2468-12
Red Blood Cells W087011013731; W087011014016; W085812002035; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. 3 B-2469-12
Blood and Blood Products for Reprocessing W087011014016; Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. 1 B-2470-12
Red Blood Cells (Apheresis) W085012000312; W085012000312; W086112000956; W086112000956; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. 4 B-2471-12
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