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U.S. Department of Health and Human Services

Enforcement Report - Week of February 6, 2013

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Event Detail

Event ID 51265
Product Type Biologics
Status Terminated
Recalling Firm American National Red Cross (The)
City Dedham
State MA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2008-11-01
Initial Firm Notification of
Consignee or Public
Telephone
Distribution Pattern MA, ME, NH, NY, PA

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Platelets Pheresis Leukocytes Reduced 004FG06532, 004FG06535, 004FP94622, 004FP94623, 004FP94626, 004FP94628, 004FP94630, 004GC27533, 004FG06537 (Parts 1 & 2), 004FH06061 (Parts 1, 2, & 3), 004FH06063 (Parts 1 & 2), 004FP94620 (Parts 1 & 2), 004FP94627 (Parts 1, 2, & 3), 004FP94629 (Parts 1 & 2), 004FP94631 (Parts 1 & 2) Class III Blood products, which were incorrectly tested for human T-lymphotropic virus (HTLV), were distributed. 24 units B-0337-13
Platelets Pheresis Leukocytes Reduced Irradiated 004FG06539 (Parts 1 & 2), 004FH06057 (Parts 1 & 2), 004FP94622 (Parts 1 & 2), 004FP94628, 004FP94631 Class III Blood products, which were incorrectly tested for human T-lymphotropic virus (HTLV), were distributed. 8 units B-0336-13
Red Blood Cells Leukocytes Reduced 004E25855, 004E25857, 004E25868, 004F77410, 004F77419, 004F77468, 004FJ44301, 004FJ44308, 004J10538, 004J10546, 004M56906 Class III Blood products, which were incorrectly tested for human T-lymphotropic virus (HTLV), were distributed. 11 units B-0335-13
Red Blood Cells Leukocytes Reduced Irradiated 004E25878, 004E25879, 004F77446, 004FJ44307, 004FJ44310, 004J10528, 004J10531, 004N71839, 004N71842, 004N71862, 004N71866, 004N71867, 004N71875 Class III Blood products, which were incorrectly tested for human T-lymphotropic virus (HTLV), were distributed. 13 units B-0334-13
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