Drug recall
Red Blood Cells Leukocytes Reduced
FDA recall event 70864 · Class III · South Bend Medical Foundation, Inc.
Key facts
| Event ID | 70864 |
|---|---|
| Recall numbers | B-0598-15 |
| Recalling firm | South Bend Medical Foundation, 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, which tested negative for HTLV-I/II, but was collected from a donor who was previously deferred for testing positive for HTLV-I/II, was distributed. |
| Initiation date | Mar 6, 2015 |
| Report date | May 13, 2015 |
| Termination date | May 6, 2015 |
| 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 · Source date: