Recall Z-0211-06 ยท MIE Heart-Valve, Allograft
Cryolife Inc
CryoValve, Alt Pulmonary Valve
| Date | Nov 30, 2005 (initiated Nov 19, 2003) |
| Status | Terminated |
| Reason | Previously released tissues no longer meet CryoLife's enhanced suitability release criteria because donors possessed a positive post processing microbiological culture of 'potentially pathogenic' organisms. |
| Root cause | Other |
| Action | Consignees were notified by letter starting 11/17/2003. |
| Quantity | 1 unit |
| Distribution | AR, AZ, CA, CT, DC, FL, IL, LA, MN, NC, NH, NV, NY, TN, TX, UT, and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.