Drug recall
Fresh frozen plasma
FDA recall event 25261 · Class II · American National Red Cross Southeastern Michigan Region
Key facts
| Event ID | 25261 |
|---|---|
| Recall numbers | B-0460-3, B-0461-3 |
| Recalling firm | American National Red Cross Southeastern Michigan Region |
| Product type | Biologics |
| Products | Fresh frozen plasma, Platelets |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Blood products, corresponding to a unit of Red Blood Cells that was possibly contaminated with coagulase negative Staphylococcus sp. bacteria. |
| Initiation date | Jun 12, 2002 |
| City | Detroit |
| Country | United States |
| FEI number | 1873044 |
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