Device product
CryoPatch SG Pulmonary Hemi-Artery, 1 graft
Z-0121-2019
Product summary
- Firm
- CryoLife, Inc.
- Event
- Event 81095
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 graft
- Official record key
device-enforcement:Z-0121-2019
Official wording
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.
Code information: Model Number SGPH00, Serial Number 10978889, Lot Number 144125, Expiration Date 05/16/2022
Distribution pattern: US Nationwide in the state of California.
Derived failure modes
-
Unknown
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.