Drug recall
Fresh Frozen Plasma
FDA recall event 70607 · Class II · Winter Haven Hospital, Inc.
Key facts
| Event ID | 70607 |
|---|---|
| Recall numbers | B-0502-15, B-0503-15 |
| Recalling firm | Winter Haven Hospital, Inc. |
| Product type | Biologics |
| Products | Fresh Frozen Plasma, Red Blood Cells Leukocytes Reduced |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed, Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. |
| Initiation date | Feb 11, 2015 |
| Report date | Apr 15, 2015 |
| Termination date | Apr 7, 2015 |
| City | Winter Haven |
| State | FL |
| Country | United States |
| FEI number | 1073507 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: