Drug recall
Cornea
FDA recall event 69385 · Class II · South Dakota Lions Eye Bank, Inc
Key facts
| Event ID | 69385 |
|---|---|
| Recall numbers | B-0113-15 |
| Recalling firm | South Dakota Lions Eye Bank, Inc |
| Product type | Biologics |
| Products | Cornea |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Human Cornea, recovered from a donor whose donor eligibility determination failed to assure the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable… |
| Initiation date | Aug 14, 2014 |
| Report date | Nov 5, 2014 |
| Termination date | Oct 28, 2014 |
| City | Sioux Falls |
| State | SD |
| Country | United States |
| FEI number | 3000718537 |
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 · Source date: