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Stryker Corporation: Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are intended to be used with the Fl

Medical DevicesSource: FDA (device) · Date: 2026-05-20

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Stryker Corporation
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.
Reason / hazard
Due to nonconforming products being inadvertently distributed.
Classification
Class II
Status
Ongoing
Distribution / sold at
U.S. Nationwide distribution in the state of GA.
Recall initiated
2026-04-09
Code info
Catalog Number: LL0006 UDI-DI code: 00860936000365 Lot Number: B000576601
Product quantity
10 tube sets
Voluntary mandated
Voluntary: Firm initiated
City
San Jose
State
CA
Country
United States
Event id
98696
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