Drug recall
Platelets
FDA recall event 27735 · Class II, Class III · Central Indiana Regional Blood Center, Inc
Key facts
| Event ID | 27735 |
|---|---|
| Recall numbers | B-0486-4, B-0487-4, B-0488-4, B-0489-4, B-485-4 |
| Recalling firm | Central Indiana Regional Blood Center, Inc |
| Product type | Biologics |
| Products | Platelets, Platelets Pheresis Leukocytes Reduced, Recovered Plasma, 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, which were collected from donors whose donor history screening was incomplete resulting in not adequately determing donor suitability, were distributed., Blood products, which were collected from donors whose donor history screening was incomplete resulting in not adequately determining donor suitability, were distributed. |
| Initiation date | Nov 15, 2003 |
| Termination date | Jan 23, 2004 |
| City | Indianapolis |
| Country | United States |
| FEI number | 1873403 |
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