Recall Z-1056-04 ยท MIE Heart-Valve, Allograft
Cryolife Inc
CryoValve Pulmonary Valve SG
| Date | Jul 20, 2004 (initiated Jun 17, 2004) |
| Status | Terminated |
| Reason | The Amphotericin B Intermediate (G10030), one of the components of the antimicrobial solution, had reached expiration at the time it was utilized to manufacture the Combo Antibiotic Stock Solution (G10070). |
| Root cause | Other |
| Action | Consignees were notified by letter on 06/17/2004 and 06/18/2004. |
| Quantity | 1 unit |
| Distribution | CA, OH, OR, PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.