Device product
MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL
Z-0565-2022
Product summary
- Event
- Event 89290
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2652 units
- Official record key
device-enforcement:Z-0565-2022
Official wording
Reason: The External Retention Bolster contained in the kit may be a larger diameter than the tube.
Code information: 1) Code 7160-20, Lots 30116959, 30132543, 30132545, and 30132546 2) Code 7640-20, Lots 30129345
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada and Chile.
Derived failure modes
-
Unknown
The External Retention Bolster contained in the kit may be a larger diameter than the tube.