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.
This recall is currently active, issued September 10, 2024. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- May 7, 2024
- Posted
- September 10, 2024
- Recall Number
- Z-3094-2024
- Quantity
- 230 units
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for an incomplete seal on the packaging tray.
Distribution
US Nationwide distribution.
Lot / Code Info
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.
Root Cause
Under Investigation by firm
Action Taken
Medline notified consignees on about 05/06/2024 via letter sent email or First-Class mail. Consignees were instructed to examine inventory and quarantine any affected units, return any affected product that they may have on hand for credit or replacement, notify customers or personnel if the affected product was further distributed or transferred, and complete and return the response form.