Device product
MEDLINE ReNewal Ligasure Blunt Tip Sealer/Divider Nano-Coated Compatible with FT10 Generator, REF LF1844CR. electrosurgical instrument
Z-0117-2024
Product summary
- Event
- Event 92920
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 11 units
- Official record key
device-enforcement:Z-0117-2024
Official wording
Reason: Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray.
Code information: UDI/DI 10888277680418 (each), 20888277680415 (case), Lot Numbers: 498004
Distribution pattern: US
Derived failure modes
-
Labeling or packaging
incomplete seal