Drug recall
Blood and Blood Products for Reprocessing
FDA recall event 67336 · Class II, Class III · OneBlood, Inc.
Key facts
| Event ID | 67336 |
|---|---|
| Recall numbers | B-0419-14, B-0420-14, B-0421-14, B-0422-14, B-0423-14 |
| Recalling firm | OneBlood, Inc. |
| Product type | Biologics |
| Products | Blood and Blood Products for Reprocessing, Fresh Frozen Plasma, Platelets Pooled Leukocytes Reduced, Red Blood Cells, Red Blood Cells Leukocytes Reduced |
| Classification | Class II, Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed, Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. |
| Initiation date | Dec 10, 2013 |
| Report date | Feb 26, 2014 |
| Termination date | Feb 18, 2014 |
| City | Hialeah |
| State | FL |
| Country | United States |
| FEI number | 1072594 |
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: