Device product
Ellik Evacuator Adapter, Locking. Model Number: 190-NRS. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
Z-2145-2025
Product summary
- Event
- Event 96982
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5 units
- Official record key
device-enforcement:Z-2145-2025
Official wording
Reason: Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Code information: Model Number: 190-NRS. UDI-DI: 00821925003521. All lot numbers
Distribution pattern: International distribution to the country of Japan.
Derived failure modes
-
Unknown
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).