Device product
Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are intended to be used with the FluidSmart Fluid Management System, which is intended for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic disciplines.
Z-2166-2026
Product summary
- Event
- Event 98696
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 10 tube sets
- Official record key
device-enforcement:Z-2166-2026
Official wording
Reason: Due to nonconforming products being inadvertently distributed.
Code information: Catalog Number: LL0006 UDI-DI code: 00860936000365 Lot Number: B000576601
Distribution pattern: U.S. Nationwide distribution in the state of GA.
Derived failure modes
-
Unknown
Due to nonconforming products being inadvertently distributed.