Drug recall
CryoGraft, Pulmonary Trunk Patch
FDA recall event 28468 · Class III · Cryolife Inc
Key facts
| Event ID | 28468 |
|---|---|
| Recall numbers | B-1497-4 |
| Recalling firm | Cryolife Inc |
| Product type | Biologics |
| Products | CryoGraft, Pulmonary Trunk Patch, CryoVein, Saphenous Vein |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Human tissue, processed using an expired anti-microbial solution (AMS), was distributed. |
| Initiation date | Feb 25, 2004 |
| Termination date | Jul 19, 2012 |
| 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