Drug recall
Fresh Frozen Plasma
FDA recall event 30195 · Class II · ARC Blood Services, New England Region
Key facts
| Event ID | 30195 |
|---|---|
| Recall numbers | B-0865-5, B-0866-5, B-0867-5, B-0868-5, B-0869-5, B-0870-5, B-0871-5, B-0872-5, B-0873-5, B-0874-5, B-0875-5, B-0876-5 and 4 more |
| Recalling firm | ARC Blood Services, New England Region |
| Product type | Biologics |
| Products | Fresh Frozen Plasma, Fresh Frozen Plasma (Apheresis), Plasma Frozen, Platelets Pheresis, Irradiated, Platelets Pheresis, Leukocytes Reduced and 11 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. |
| Initiation date | Mar 9, 2004 |
| Termination date | Apr 22, 2005 |
| City | Dedham |
| Country | United States |
| FEI number | 1270026 |
At a glance
- 10–99 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