Drug recall
CryoGraft, Achilles Tendon; CryoGraft, Hemi Patellar Tendon; CryoGraft, Tibialis Tendon; CryoVein, Saphenous…
FDA recall event 32839 · Class I, Class II · CryoLife, Inc.
Key facts
| Event ID | 32839 |
|---|---|
| Recall numbers | B-0339-06, B-0340-06 |
| Recalling firm | CryoLife, Inc. |
| Product type | Biologics |
| Products | CryoGraft, Achilles Tendon; CryoGraft, Hemi Patellar Tendon; CryoGraft, Tibialis Tendon; CryoVein, Saphenous Vein, CryoVein, Femoral Vein with Valve; CryoVein, Femoral Vein SG, CryoGraft, Lateral Meniscus-Bone Left; CryoGraft, Semitendinosus/Gracilis Tendon; CryoGraft, Tibialis Tendon |
| Classification | Class I, Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Human tissues, associated with complaints of recipient infection, were distributed. |
| Initiation date | Apr 19, 2004 |
| Termination date | Mar 13, 2008 |
| City | Kennesaw |
| State | GA |
| 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