Recall Z-2272-2018 ยท DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
CryoLife, Inc.
Cryopatch SG Pulmonary Human Cardiac Branch, Catalog Number SGP020
| Date | May 14, 2018 |
| Status | Terminated |
| Reason | Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine. |
| Root cause | Under Investigation by firm |
| Action | The firm notified the consignees by letter on 05/14/2018. |
| Quantity | 1 unit |
| Distribution | AR, OH |
| 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 |