Drug recall
Cryoprecipitated AHF
FDA recall event 28359 · Class II · American Red Cross-Ches Reg
Key facts
| Event ID | 28359 |
|---|---|
| Recall numbers | B-1597-4, B-1598-4, B-1599-4, B-1600-4, B-1601-4, B-1602-4 |
| Recalling firm | American Red Cross-Ches Reg |
| Product type | Biologics |
| Products | Cryoprecipitated AHF, Plasma, Frozen, Plasma, Frozen, Cryoprecipitate Reduced, Platelets, Red Blood Cells, For Further Manufacturing into Injectables and 1 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Blood products, collected from an ineligible donor due to a subsequent disclosure of previous positive Hepatitis B testing, were distributed. |
| Initiation date | Jul 24, 2003 |
| Termination date | Jul 22, 2004 |
| City | Baltimore |
| Country | United States |
| FEI number | 1173011 |
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