Drug recall
Cryoprecipitated AHF
FDA recall event 66614 · Class II · OneBlood, Inc.
Key facts
| Event ID | 66614 |
|---|---|
| Recall numbers | B-0125-14, B-0126-14, B-0127-14 |
| Recalling firm | OneBlood, Inc. |
| Product type | Biologics |
| Products | Cryoprecipitated AHF, Platelets, Platelets Pooled Leukocytes Reduced |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. |
| Initiation date | Sep 24, 2013 |
| Report date | Nov 20, 2013 |
| Termination date | Nov 14, 2013 |
| 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: