Recall Z-0121-2019 ยท DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
CryoLife, Inc.
CryoPatch SG Pulmonary Hemi-Artery, 1 graft
| Date | Sep 6, 2018 |
| Status | Terminated |
| Reason | The conduit length and branch length of a SG Pulmonary Hemi-Artery were switched on the product labeling. The graft labeling indicates the conduit length is 1.0cm and the branch length is 4.5cm. |
| Root cause | Labeling mix-ups |
| Action | A formal recall notice was not sent to the customer involved. The customer complaint was followed up on and the affected graft returned prior to the initiation of the recall for investigation. |
| Quantity | 1 graft |
| Distribution | US Nationwide in the state of California. |
| 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 |