Drug recall
Pooled Cryoprecipitated AHF
FDA recall event 89018 · Class II · South Bend Medical Foundation, Inc.
Key facts
| Event ID | 89018 |
|---|---|
| Recall numbers | B-0080-2022, B-0081-2022 |
| Recalling firm | South Bend Medical Foundation, Inc. |
| 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, for which donor eligibility screening was incomplete, were distributed. |
| Initiation date | Sep 28, 2021 |
| Report date | Dec 15, 2021 |
| Termination date | Dec 9, 2021 |
| City | South Bend |
| State | IN |
| Country | United States |
| FEI number | 1870308 |
At a glance
- 1–9 Products in this recall
- None 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: