Device product
Medline ReNewal Reprocessed Covidien LigaSure Impact, Sealer/Divider, Nano-Coated, Compatible w/ FT10 18cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF4418CR.
Z-3094-2024
Product summary
- Event
- Event 95126
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 230 units
- Official record key
device-enforcement:Z-3094-2024
Official wording
Reason: Potential for an incomplete seal on the packaging tray.
Code information: Item Number: LF4418CR. UDI/DI: 20888277680446 (case), 10888277680449 (each). Lot Numbers: 500376, 500379, 500380, 500381, 500382, 500504, 500506, 500548, 500559, 500652, 500695, 500874, 503004, 503289.
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Labeling or packaging
incomplete seal