Recall Z-3094-2024 ยท NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
MEDLINE INDUSTRIES, LP - Northfield
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.
| Date | Sep 10, 2024 (initiated May 7, 2024) |
| Status | Open, Classified |
| Reason | Potential for an incomplete seal on the packaging tray. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 230 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153745 | Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider Surgical Instrument Service and Savings Inc.(Dba Medline Ren, May 2, 2016 |