Recall Z-0809-2014 ยท DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
CryoLife, Inc.
Pulmonary Hemi-Artery SG Used in heart surgery
| Date | Jan 23, 2014 (initiated Nov 22, 2013) |
| Status | Terminated |
| Reason | Serological testing for the donor was performed with a blood sample that may have been hemodiluted due to the administration of normal saline to the donor prior to death. |
| Root cause | Other |
| Action | CryoLife sent an Urgent Human Tissue Recall letter dated November 22, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact CryoLife to arrange for the return of the affected product. If the affected product had been implanted or discarded, customers should provide information regarding the status of the affected product on the attached self-addressed postcard. Customers with questions were instructedto contact the Field Assurance Department at 800-438-8285. For questions regarding t |
| Quantity | One |
| Distribution | US distribution in CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101866 | CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH Cryolife, Inc., Jul 23, 2010 |