Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 ...
Reason for Recall / Hazard
Due to nonconforming products being inadvertently distributed.
Product Description & Identification
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.
Affected Products
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.
Additional Source Details
| Field | Value |
|---|---|
| City | San Jose |
| State | CA |
| Event id | 98696 |
| Address 1 | 5900 Optical Ct |
| Code info | Catalog Number: LL0006 UDI-DI code: 00860936000365 Lot Number: B000576601 |
| Postal code | 95138-1400 |
| Report date | 20260520 |
| Product type | Devices |
| Product quantity | 10 tube sets |
| Reason for recall | Due to nonconforming products being inadvertently distributed. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260409 |
| Initial firm notification | Letter |
| Center classification date | 20260512 |
Overview
- Recalling FirmStryker Corporation
- StatusOngoing
- Risk LevelClass II
- DistributionU.S. Nationwide distribution in the state of GA.