Device product
Medline Renewal LigaSure Maryland Jaw Sealer/Divider NanoCoated, Compatible w/FT10 37 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Z-0476-2026
Product summary
- Event
- Event 97822
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 57,244 units
- Official record key
device-enforcement:Z-0476-2026
Official wording
Reason: Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
Code information: UDI/DI 10888277719415 (each), 20888277719412 (case), All Lots
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.