Drug recall
Blood and Blood Products for Reprocessing
FDA recall event 82285 · Class II · OneBlood, Inc.
Key facts
| Event ID | 82285 |
|---|---|
| Recall numbers | B-0401-2019, B-0402-2019, B-0403-2019 |
| Recalling firm | OneBlood, Inc. |
| Product type | Biologics |
| Products | Blood and Blood Products for Reprocessing, Fresh Frozen Plasma, Pooled Cryoprecipitated AHF |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Blood products, collected from a donor who was previously deferred for a history of intravenous drug use, were distributed. |
| Initiation date | Feb 5, 2019 |
| Report date | Mar 27, 2019 |
| Termination date | Mar 20, 2019 |
| City | St Petersburg |
| State | FL |
| Country | United States |
| FEI number | 1070196 |
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: