Device product
MEDLINE ReNewal Ligasure Maryland Jaw Sealer/Divider Nano-Coated Complatible with FT10 Generator, REF LF1944CR. electrosurgical instrument
Z-0118-2024
Product summary
- Event
- Event 92920
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 58 units
- Official record key
device-enforcement:Z-0118-2024
Official wording
Reason: Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray.
Code information: UDI/DI 10888277719439 (each), 20888277719436 (case), Lot Numbers: 498006, 498837, 498838, 499150, 499151
Distribution pattern: US
Derived failure modes
-
Labeling or packaging
incomplete seal