Drug recall
Human Cornea
FDA recall event 78476 · Class II · Transplant Services Center UT Southwestern Medical Center
Key facts
| Event ID | 78476 |
|---|---|
| Recall numbers | B-0107-2018 |
| Recalling firm | Transplant Services Center UT Southwestern Medical Center |
| Product type | Biologics |
| Products | Human Cornea |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Human corneas, not tested adequately and appropriately to reduce the risk of transmission of relevant communicable diseases, were distributed. |
| Initiation date | Oct 26, 2017 |
| Report date | Nov 15, 2017 |
| Termination date | Nov 9, 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: