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U.S. Department of Health and Human Services

Enforcement Report - Week of July 10, 2013

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Event Detail

Event ID 40694
Product Type Biologics
Status Terminated
Recalling Firm Community Blood Center of the Ozarks
City Springfield
State MO
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2005-08-11
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern FL; MO; NJ; AR; Austria

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Red Blood Cells 6643888; 6643907; 6643885; 6643794; 6643796; 6643919 6643938; 6643936; 6643878; 6653781; 6643910; 6643915 6639466; 6653784; 6639424; 6639423; 6639449; 6634622; 6633512; 6639467; 6643284; 6634456; 6643307; 6629134; 6643778; 6643494; 6643646; 8913062; 6651719 Class II Blood Collection/Sterility compromised. 29 Units B-1531-13
Cryoprecipitated AHF 6634622; 6629134 Class II Blood products, possibly contaminated with air, were distributed. 2 units B-1532-13
Platelets 6633512; 6635965 Class II Blood products, possibly contaminated with air, were distributed. 2 units B-1533-13
Fresh Frozen Plasma 6633512; 6634456; 6635965 Class II Blood products, possibly contaminated with air, were distributed. 3 units B-1534-13
Red Blood Cells Leukocytes Reduced 6654187; 6639454; 6644279; 6639388; 6639448; 6635965; 6643694; 6643690 Class II Blood products, possibly contaminated with air, were distributed. 8 units B-1535-13
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