Drug recall
Red blood cells, leukocytes reduced.
FDA recall event 38699 · Class III · South Bend Medical Foundation
Key facts
| Event ID | 38699 |
|---|---|
| Recall numbers | B-1745-08 |
| Recalling firm | South Bend Medical Foundation |
| Product type | Biologics |
| Products | Red blood cells, leukocytes reduced. |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Blood products, collected using a genesis mixer scale that had unacceptable quality control results documented, were distributed. |
| Initiation date | Apr 17, 2007 |
| Termination date | Aug 26, 2008 |
| City | South Bend |
| State | IN |
| Country | United States |
| FEI number | 1870308 |
At a glance
- 1–9 Products in this recall
- None 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