Recall Z-1219-2011 ยท MIE Heart-Valve, Allograft
CryoLife, Inc.
Pulmonary Valve & Conduit SG Used in heart surgery
| Date | Feb 11, 2011 (initiated Jan 7, 2011) |
| Status | Terminated |
| Reason | A pre-processing culture performed on a companion allograft (Aortic Valve & Conduct SG) tested positive for Staphylococcus aureus. |
| Root cause | Other |
| Action | The firm, Cryolife, sent an "Urgent-Human Tissue Recall" letter dated January 7, 2011 to the consignee/customer. The letter describe the product, problem and action to be taken by the customer. The customer was instructed to determine if any additional patient surveillance or intervention was necessary, and to complete and return the enclosed postcard affirming that the notification was received. If you have any questions, please contact Cryolife's Medical Director at 1-678-290-4403. |
| Quantity | One |
| Distribution | Nationwide distribution: USA state of: MI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083106 | CRYOVALVE SG PULMONARY VALVE AND CONDUIT Cryolife, Inc., Feb 6, 2009 |