United StatesThermedx FluidSmart Urology Tube Set (REF LL0006, UDI-DI 00860936000365, Lot B000576601) used with the FluidSmart Fluid Management System for irrigation, fluid warming and volume/deficit measurements in laparoscopic and endoscopic procedures is affected. The sets were recalled because nonconforming products were inadvertently distributed; affected units were distributed nationwide in the U.S., in the state of GA.
What's being recalled
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.
Recalling firm: Stryker Corporation, San Jose, CA, United States.
How to identify it
Catalog Number: LL0006 UDI-DI code: 00860936000365 Lot Number: B000576601
The hazard
Due to nonconforming products being inadvertently distributed.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
U.S. Nationwide distribution in the state of GA.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)