Drug recall
Red Blood Cells, Leukocytes Reduced
FDA recall event 96301 · Class II · The American National Red Cross
Key facts
| Event ID | 96301 |
|---|---|
| Recall numbers | B-0216-2025 |
| Recalling firm | The American National Red Cross |
| Product type | Biologics |
| Products | Red Blood Cells, Leukocytes Reduced |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Leukoreduced Red Blood Cells, collected from a donor with a history of a positive test result for Babesia, was distributed. |
| Initiation date | Dec 6, 2024 |
| Report date | Mar 26, 2025 |
| Termination date | Mar 18, 2025 |
| City | Cleveland |
| State | OH |
| Country | United States |
| FEI number | 1573019 |
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: