Enforcement Report - Week of September 19, 2012
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Product Detail
| Product Description | Source Plasma |
|---|---|
| Recall Number | B-2078-12 |
| Classification | Class III |
| Code Info | 2160066934; 2160068103; 2160069088; 2160071419; 2160072603; |
| Product Distributed Qty | 5 units |
| Reason For Recall | Blood Products, collected from a donor whose suitability to donate was not adequately determined, were distributed. |
Event Detail
| Event Id | 62268 |
|---|---|
| Product Type | Biologics |
| Status | Terminated |
| Recalling Firm | Plasmacare Inc |
| City | Cleveland |
| State | OH | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-05-09 |
| Initial Firm Notification of Consignee or Public | |
| Distribution Pattern | CA |
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