Z-2166-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 20, 2026
- Initiation Date
- April 9, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 tube sets
Product Description
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.
Reason for Recall
Due to nonconforming products being inadvertently distributed.
Distribution Pattern
U.S. Nationwide distribution in the state of GA.
Code Information
Catalog Number: LL0006 UDI-DI code: 00860936000365 Lot Number: B000576601