Drug recall
Fresh Frozen Plasma
FDA recall event 29638 · Class II · ARC Blood Services, New England Region
Key facts
| Event ID | 29638 |
|---|---|
| Recall numbers | B-1832-4, B-1833-4, B-1834-4 |
| Recalling firm | ARC Blood Services, New England Region |
| Product type | Biologics |
| Products | Fresh Frozen Plasma, Recovered Plasma, Red Blood Cells, Leukoctyes Reduced |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Blood products, collected from an unsuitble donor due to a history of residing in an area considered at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed., Blood products, collected from donors whose medical history interview did not have documentation to answers to the medical history questions related to risk factors for creutzfeldt-Jacob disease… |
| Initiation date | Apr 9, 2004 |
| Termination date | Sep 1, 2004 |
| City | Dedham |
| Country | United States |
| FEI number | 1270026 |
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