Drug recall
Human Tissue for Transplantation, Corneas
FDA recall event 31478 · Class II · Tissue Banks International
Key facts
| Event ID | 31478 |
|---|---|
| Recall numbers | B-1102-5 |
| Recalling firm | Tissue Banks International |
| Product type | Biologics |
| Products | Human Tissue for Transplantation, Corneas |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Human tissue for transplantation, that tested negative for hepatitis prior to distribution, but was subsequently found to test repeatedly reactive for antibodies to hepatitis B core antigen (anti-HBc)… |
| Initiation date | Mar 2, 2005 |
| City | Baltimore |
| Country | United States |
| FEI number | 1181343 |
At a glance
- 1–9 Products in this recall
- 1–9 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