Drug recall
Red Blood Cells, Leukocytes Reduced
FDA recall event 95535 · Class II · WellSpan York Hospital Donor Center
Key facts
| Event ID | 95535 |
|---|---|
| Recall numbers | B-0034-2025 |
| Recalling firm | WellSpan York Hospital Donor Center |
| 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, which were labeled as leukocytes reduced but failed the monthly QC residual white blood cell count, were distributed. |
| Initiation date | Jul 25, 2024 |
| Report date | Nov 13, 2024 |
| Termination date | Nov 1, 2024 |
| City | York |
| State | PA |
| Country | United States |
| FEI number | 1000121170 |
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: