Drug recall
Achilles Tendon
FDA recall event 25820 · Class I · Cryolife Inc
Key facts
| Event ID | 25820 |
|---|---|
| Recall numbers | B-0864-3, B-0865-3, B-0866-3, B-0867-3, B-0869-3, B-0870-3, B-0871-3, B-868-3 |
| Recalling firm | Cryolife Inc |
| Product type | Biologics |
| Products | Achilles Tendon, Femoral Popliteal Artery, Fermoral Vein with Valve, Pericardium, Saphenous Vein and 3 more |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Human tissues for transplantation, collected from donors whose companion sample, from a different site, positive for microorganisms., Human tissues for transplantation, collected from donors whose companion sample, from a different site, positive for microorganisms, were distributed |
| Initiation date | Feb 6, 2003 |
| Termination date | Aug 19, 2004 |
| City | Kennesaw |
| Country | United States |
| FEI number | 3001451326 |
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