MEDLINE ReNewal Ligasure Blunt Tip Sealer/Divider Nano-Coated Compatible with FT10 Generator, REF LF1844CR. electrosurgical instrument
This recall is currently active, issued October 16, 2023. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- August 3, 2023
- Posted
- October 16, 2023
- Recall Number
- Z-0117-2024
- Quantity
- 11 units
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray.
Distribution
US
Lot / Code Info
UDI/DI 10888277680418 (each), 20888277680415 (case), Lot Numbers: 498004
Root Cause
Packaging
Action Taken
Medline issued a recall notice to its consignees by email on 08/03/2023. The notice explained the problem and the potential risk. Those consignees who have transferred possession of the affected product were directed to notify their customers. The firm is seeking the return of the affected product. An error in the model number was noted (missing an "R" at the end) and the firm issued an updated letter on 09/19/2023 with the corrected number.