Drug recall
Apheresis Platelets, Leukocytes Reduced
FDA recall event 94698 · Class II · We Are Blood
Key facts
| Event ID | 94698 |
|---|---|
| Recall numbers | B-0353-2024, B-0354-2024, B-0355-2024, B-0356-2024, B-0357-2024 |
| Recalling firm | We Are Blood |
| Product type | Biologics |
| Products | Apheresis Platelets, Leukocytes Reduced, Apheresis Platelets, Leukocytes Reduced, Irradiated, Apheresis Red Blood Cells, Leukocytes Reduced, Pooled Cryoprecipitated AHF, Red Blood Cells, Leukocytes Reduced |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Blood products, for which donor eligibility was incomplete, were distributed. |
| Initiation date | Dec 21, 2023 |
| Report date | Jun 19, 2024 |
| Termination date | Jun 10, 2024 |
| City | Austin |
| State | TX |
| Country | United States |
| FEI number | 1671794 |
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: