Drug recall
Recovered Plasma
FDA recall event 39436 · Class II, Class III · Blood Systems, Inc.
Key facts
| Event ID | 39436 |
|---|---|
| Recall numbers | B-1604-08, B-1605-08 |
| Recalling firm | Blood Systems, Inc. |
| Product type | Biologics |
| Products | Recovered Plasma, Red Blood Cells Leukocytes Reduced |
| Classification | Class II, Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Blood product, collected from a donor whose health history screening was inadequately performed, was distributed., Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed. |
| Initiation date | Jan 6, 2005 |
| Termination date | Jun 30, 2008 |
| City | Reno |
| State | NV |
| Country | United States |
| FEI number | 2971465 |
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