HIGH

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...

Due to nonconforming products being inadvertently distributed.

Quick Facts at a Glance

Recall Date
April 9, 2026
Hazard Level
HIGH
Brand
Stryker
Geographic Scope
1 states

Hazard Information

Due to nonconforming products being inadvertently distributed.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Stryker Corporation or your healthcare provider for instructions. Notification method: Letter

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Full 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: Due to nonconforming products being inadvertently distributed.. Classification: Class II. Quantity: 10 tube sets. Distribution: U.S. Nationwide distribution in the state of GA.

Safety Guide

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Product Classification

Product Details

Brand
Model Numbers
Catalog Number: LL0006 UDI-DI code: 00860936000365 Lot Number: B000576601
Affected States
ALL
Report Date
May 20, 2026
Recall Status
ACTIVE

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