Recall Z-1219-2019 ยท DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
CryoLife, Inc.
CryoPatch SG Pulmonary Hemi-Artery Patch
| Date | Nov 21, 2016 |
| Status | Terminated |
| Reason | The device is recalled due to donor ineligibility of released human tissue. The firm received information that the tissue donor's blood culture tested positive for Enterobacter cloacae. |
| Root cause | Release of Material/Component prior to receiving test results |
| Action | The firm sent the physician a letter on 11/21/2016. |
| Quantity | 1 |
| Distribution | Product was shipped to Texas |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091626 | CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH Cryolife, Inc., Aug 7, 2009 |