Drug recall
Pooled Cryoprecipitated AHF
FDA recall event 91904 · Class II · Suncoast Communities Blood Bank, Inc.
Key facts
| Event ID | 91904 |
|---|---|
| Recall numbers | B-0281-2023, B-0282-2023 |
| Recalling firm | Suncoast Communities Blood Bank, Inc. |
| Product type | Biologics |
| Products | Pooled Cryoprecipitated AHF, Red Blood Cells, Leukocytes Reduced |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Blood Products, collected from a donor who was a resident of a malaria endemic area, was distributed. |
| Initiation date | Feb 3, 2023 |
| Report date | Mar 29, 2023 |
| Termination date | Mar 20, 2023 |
| City | Bradenton |
| State | FL |
| Country | United States |
| FEI number | 1051993 |
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 · Source date: