Drug recall
CryoGraft, Pericardium Tissue
FDA recall event 28517 · Class I · Cryolife Inc
Key facts
| Event ID | 28517 |
|---|---|
| Recall numbers | B-0341-6 |
| Recalling firm | Cryolife Inc |
| Product type | Biologics |
| Products | CryoGraft, Pericardium Tissue, Cryo Vein, Femoral Vein, Cryo Vein, Saphenous Vein Tissue |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Human tissues for transplantation, procured form donors for whom the companion sample from a different site was positive for microorganisms, were distributed. |
| Initiation date | Dec 19, 2003 |
| Termination date | Feb 8, 2006 |
| 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