Drug recall
Pooled Cryoprecipitated AHF
FDA recall event 89434 · Class II · American Red Cross Blood Svcs
Key facts
| Event ID | 89434 |
|---|---|
| Recall numbers | B-0216-2022, B-0217-2022 |
| Recalling firm | American Red Cross Blood Svcs |
| 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 whose arm preparation was not performed in a manner that ensures sterility, were distributed. |
| Initiation date | Oct 15, 2021 |
| Report date | Feb 9, 2022 |
| Termination date | Jan 28, 2022 |
| City | Durham |
| State | NC |
| Country | United States |
| FEI number | 1075944 |
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: