Drug recall
Fresh Frozen Plasma
FDA recall event 31181 · Class III · American Red Cross, Penn Jersey
Key facts
| Event ID | 31181 |
|---|---|
| Recall numbers | B-0844-5, B-0845-5 |
| Recalling firm | American Red Cross, Penn Jersey |
| Product type | Biologics |
| Products | Fresh Frozen Plasma, Red Blood Cells, Leukocytes Reduced |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Blood products, associated with a platelet pool implicated in a transfusion reaction and possibly contaminated with gram positive rods, were distributed. |
| Initiation date | Aug 10, 2004 |
| Termination date | Apr 11, 2005 |
| City | Philadelphia |
| Country | United States |
| FEI number | 2573021 |
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