Enforcement Report - Week of September 26, 2012
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Product Detail
| Product Description | Red Blood Cells Leukocytes Reduced Irradiated |
|---|---|
| Recall Number | B-2357-12 |
| Classification | Class II |
| Code Info | W0423110455999 |
| Product Distributed Qty | 1 unit |
| Reason For Recall | Blood products, collected from a donor with a history of malaria, were distributed. |
Event Detail
| Event Id | 62300 |
|---|---|
| Product Type | Biologics |
| Status | Terminated |
| Recalling Firm | Blood Systems, Inc |
| City | Billings |
| State | MT | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-04-23 |
| Initial Firm Notification of Consignee or Public | |
| Distribution Pattern | Products were distributed to four domestic consignees including blood bank and health care facilities, located in Montana State. One of the four consignees responded that the unit was transfused. |
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