Drug recall
Apheresis Platelets, Leukocytes Reduced, Irradiated
FDA recall event 84417 · Class III · Versiti Indiana Inc
Key facts
| Event ID | 84417 |
|---|---|
| Recall numbers | B-0172-2020 |
| Recalling firm | Versiti Indiana Inc |
| Product type | Biologics |
| Products | Apheresis Platelets, Leukocytes Reduced, Irradiated |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Platelet products, not meeting product specifications, were distributed. |
| Initiation date | Oct 14, 2019 |
| Report date | Dec 18, 2019 |
| Termination date | Dec 12, 2019 |
| City | Indianapolis |
| State | IN |
| Country | United States |
| FEI number | 1873403 |
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: