Drug recall
Human Tissue for Transplantation as follows: Corneas (2), numbers SL01-11-017R1 and SL01-11-017L1; Various…
FDA recall event 29994 · Class II · Mid-America Transplant Services
Key facts
| Event ID | 29994 |
|---|---|
| Recall numbers | B-0121-5 |
| Recalling firm | Mid-America Transplant Services |
| Product type | Biologics |
| Products | Human Tissue for Transplantation as follows: Corneas (2), numbers SL01-11-017R1 and SL01-11-017L1; Various musculoskeletal tissues and skin, donor number 11001709. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Human tissue for transplantation was incorrectly tested for viral markers in that the blood sample used for testing was likely hemodiluted. |
| Initiation date | Feb 28, 2002 |
| Termination date | Nov 2, 2004 |
| City | Olivette |
| Country | United States |
| FEI number | 3001238381 |
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