Drug recall
Human Cornea
FDA recall event 79843 · Class II · Florida Lions Eye Bank, Inc.
Key facts
| Event ID | 79843 |
|---|---|
| Recall numbers | B-0496-2018 |
| Recalling firm | Florida Lions Eye Bank, Inc. |
| Product type | Biologics |
| Products | Human 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 | Apr 12, 2018 |
| Report date | Apr 25, 2018 |
| Termination date | Apr 16, 2018 |
| City | Miami |
| State | FL |
| Country | United States |
| FEI number | 1000025033 |
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: