Drug recall
Fresh Frozen Plasma
FDA recall event 37916 · Class II · ARC Blood Services, New England Region
Key facts
| Event ID | 37916 |
|---|---|
| Recall numbers | B-1415-07, B-1416-07 |
| Recalling firm | ARC Blood Services, New England Region |
| Product type | Biologics |
| Products | Fresh Frozen Plasma, Red Blood Cells |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Blood product, which tested negative for the antibody to the human immunodeficiency virus (anti-HIV) but was collected from a donor who previously tested positive for anti-HIV, was distributed. |
| Initiation date | Dec 22, 2006 |
| Termination date | Aug 17, 2007 |
| City | Dedham |
| State | MA |
| 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