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 |
|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
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