Recall Z-1560-2011 ยท DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
CryoLife, Inc.
Pulmonary Valve & Conduit SG Used in heart surgery
| Date | Mar 4, 2011 (initiated Feb 17, 2011) |
| Status | Terminated |
| Reason | Staphylococcus aureus (not methicillin resistant) identified in companion tissue. |
| Root cause | Other |
| Action | CryoLife Inc. issued a letter to the physician on February 17, 2011, advising him of the results of the testing performed on a companion cardiac allograft. The letter did not recommend explant of the allograft or special antimicrobial treatment of the patient unless medically necessary. The physician was asked to complete and return the enclosed, stamped, self-addressed postcard affirming the receipt of the notification. For any questions the physician was advised to call 770-419-3355. |
| Quantity | One |
| Distribution | Nationwide Distribution including AZ & NV |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092021 | CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT) Cryolife, Inc., May 25, 2010 |