Device product
MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL
Z-0566-2022
Product summary
- Event
- Event 89290
- Status
- Terminated
- Classification
- Class II
- Quantity
- 692 units
- Official record key
device-enforcement:Z-0566-2022
Official wording
Reason: The External Retention Bolster contained in the kit may be a larger diameter than the tube.
Code information: 1) Code 8160-20, Lot 30135103 2) Code 8640-20, Lot 30132544
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.