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U.S. Department of Health and Human Services

Enforcement Report - Week of November 6, 2013

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Event Detail

Event ID 65692
Product Type Biologics
Status Terminated
Recalling Firm OneBlood / dba CBCF
City Lauderhill
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-25
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Florida; New York

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Platelets Pooled Leukocytes Reduced W036810815344; W036810802056; 2927802; 2911416; Class II Blood products, collected from an ineligible donor, were distributed. 4 units B-2422-13
Cryoprecipitated AHF 2369454; Class II Blood products, collected from an ineligible donor, were distributed. 1 unit B-2421-13
Red Blood Cells W036810196346; 2547164; 2369454; Class II Blood products, collected from an ineligible donor, were distributed. 3 units B-2420-13
Fresh Frozen Plasma W036810196346; W036810061996; W036809202625; 2547164; Class II Blood products, collected from an ineligible donor, were distributed. 4 units B-2419-13
Platelets Pheresis Leukocytes Reduced W036809202625; Class II Blood products, collected from an ineligible donor, were distributed. 1 unit B-2418-13
Red Blood Cells Leukocytes Reduced W036810061996; Class II Blood products, collected from an ineligible donor, were distributed. 1 unit B-2417-13
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