Drug recall
Red Blood Cells, Leukocytes Reduced
FDA recall event 35398 · Class III · Blood Systems Inc
Key facts
| Event ID | 35398 |
|---|---|
| Recall numbers | B-0243-7 |
| Recalling firm | Blood Systems Inc |
| Product type | Biologics |
| Products | Red Blood Cells, Leukocytes Reduced |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Blood product, manufactured from a Whole Blood unit which contained clots, was distributed. |
| Initiation date | Aug 30, 2004 |
| Termination date | Nov 14, 2006 |
| City | Scottsdale |
| Country | United States |
| FEI number | 2084123 |
At a glance
- 1–9 Products in this recall
- 1–9 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