Drug recall
Apheresis Red Blood Cells, Leukocytes Reduced, Irradiated
FDA recall event 89408 · Class III · Versiti Michigan Inc
Key facts
| Event ID | 89408 |
|---|---|
| Recall numbers | B-0210-2022, B-0211-2022 |
| Recalling firm | Versiti Michigan Inc |
| Product type | Biologics |
| Products | Apheresis Red Blood Cells, Leukocytes Reduced, Irradiated, Red Blood Cells, Leukocytes Reduced, Irradiated |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Blood products, for which storage temperature was not documented, were distributed. |
| Initiation date | Nov 26, 2021 |
| Report date | Feb 9, 2022 |
| Termination date | Jan 28, 2022 |
| City | Saginaw |
| State | MI |
| Country | United States |
| FEI number | 1876522 |
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: