Device product
ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80
Z-0147-2026
Product summary
- Event
- Event 97654
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3 units
- Official record key
device-enforcement:Z-0147-2026
Official wording
Reason: The devices were shipped unsterilized.
Code information: UDI-DI: 10705036030881; Lot Number: 904C12
Distribution pattern: International distribution to the countries of United Arab Emirates.
Derived failure modes
-
Unknown
The devices were shipped unsterilized.