Drug recall
Cryoprecipitate AHF
FDA recall event 32279 · Class II · Central Texas Regional Blood & Tissue Center
Key facts
| Event ID | 32279 |
|---|---|
| Recall numbers | B-1619-5, B-1620-5, B-1621-5, B-1622-5, B-1623-5, B-1624-5, B-1625-5 |
| Recalling firm | Central Texas Regional Blood & Tissue Center |
| Product type | Biologics |
| Products | Cryoprecipitate AHF, Fresh Frozen Plasma Fresh Frozen Plasma, Plasma Cryoprecipitate Reduced, Platelets, Recovered Plasma and 2 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a history of jaundice for mononucleosis, were distributed., Donor should have been deferred for history of janundice at age 17 due to Epstein-Barr infection. |
| Initiation date | Mar 1, 2004 |
| Termination date | Jul 22, 2005 |
| City | Austin |
| Country | United States |
| FEI number | 1671794 |
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