Drug recall
Cornea
FDA recall event 76793 · Class II · Transplant Services Center UT Southwestern Medical Center
Key facts
| Event ID | 76793 |
|---|---|
| Recall numbers | B-0448-2017 |
| Recalling firm | Transplant Services Center UT Southwestern Medical Center |
| 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 ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant… |
| Initiation date | Mar 15, 2017 |
| Report date | Apr 5, 2017 |
| Termination date | Mar 29, 2017 |
| City | Dallas |
| State | TX |
| Country | United States |
| FEI number | 3001238005 |
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: