Warning
Stryker Corporation Recalls Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI.
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #Z-2166-2026Medical Device
Stryker Corporation Recalls Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI.
Stryker Corporation · Class II — Moderate Risk
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.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
U.S. Nationwide distribution in the state of GA.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
Sources: FDA openFDA Enforcement Database