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U.S. Department of Health and Human Services

Enforcement Report - Week of November 21, 2012

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Event Detail

Event ID 50653
Product Type Biologics
Status Terminated
Recalling Firm American National Red Cross (The)
City Farmington
State CT
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2008-11-01
Initial Firm Notification of
Consignee or Public
Telephone
Distribution Pattern CT, NY

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Platelets Pooled Leukocytes Reduced 033FL15312 (pool ID: 12845) Class III Blood products, which were incorrectly tested for human T-lymphotropic virus (HTLV), were distributed. 1 unit B-0028-13
Red Blood Cells Leukocytes Reduced 033FL15336, 033FL15339, 033GL92944, 033GL92945, 033GL92950 Class III Blood products, which were incorrectly tested for human T-lymphotropic virus (HTLV), were distributed. 5 units B-0029-13
Platelets Leukocytes Reduced 033FL15292, 033FL15296, 033FL15300, 033FL15301, 033FL15311, 033FL15318, 033FL15319, 033FL15336, 033FN15653, 033FN15659, 033FN15673, 033FN15677, 033FN15679, 033GL92930, 033GL92931, 033GL92933, 033GL92935, 033GL92944 Class III Blood products, which were incorrectly tested for human T-lymphotropic virus (HTLV), were distributed. 18 units B-0030-13
Platelets Pheresis Leukocytes Reduced 033FP67241, 033FP67243, 033FP67244 Class III Blood products, which were incorrectly tested for human T-lymphotropic virus (HTLV), were distributed. 3 units B-0031-13
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