Drug recall
Apheresis Platelets Washed, Leukocytes Reduced, Irradiated
FDA recall event 91246 · Class III · ImpactLife
Key facts
| Event ID | 91246 |
|---|---|
| Recall numbers | B-0055-2023 |
| Recalling firm | ImpactLife |
| Product type | Biologics |
| Products | Apheresis Platelets Washed, Leukocytes Reduced, Irradiated |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Leukoreduced Apheresis Platelets Washed, Irradiated, labeled with a volume significantly higher than the product's actual volume, were distributed. |
| Initiation date | Jun 7, 2022 |
| Report date | Dec 21, 2022 |
| Termination date | Dec 9, 2022 |
| City | Davenport |
| State | IA |
| Country | United States |
| FEI number | 1970356 |
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: