Drug recall
Cryoprecipitated AHF
FDA recall event 70532 · Class III · Gulf Coast Regional Blood Center
Key facts
| Event ID | 70532 |
|---|---|
| Recall numbers | B-0494-15, B-0495-15, B-0496-15 |
| Recalling firm | Gulf Coast Regional Blood Center |
| Product type | Biologics |
| Products | Cryoprecipitated AHF, Plasma Frozen Cryoprecipitated Reduced, Red Blood Cells Leukocytes Reduced |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. |
| Initiation date | Dec 16, 2014 |
| Report date | Apr 22, 2015 |
| Termination date | Apr 10, 2015 |
| City | Houston |
| State | TX |
| Country | United States |
| FEI number | 3002133806 |
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: