Device product
MEDLINE ReNewal Ligasure Sealer/Divider Nano-Coated Compatible with FT10 Generator, REF LF4418CR. electrosurgical instrument
Z-0119-2024
Product summary
- Event
- Event 92920
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 268 units
- Official record key
device-enforcement:Z-0119-2024
Official wording
Reason: Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray.
Code information: UDI/DI 10193489189759 (each), 20888277680446 (case), Lot Numbers: 498352, 498405, 498459, 498890, 498937, 499048, 499050, 499052, 499062, 499063, 499145, 499155, 499218, 499267, 499269, 499271, 499299, 499343
Distribution pattern: US
Derived failure modes
-
Labeling or packaging
incomplete seal