Device Recall Thermedx Fluid Management System

Model P4000 Serial numbers affected:  20110004, 20110007, 20110015, 20110025, 20130001-20130032, 20140001-20140005

General and Plastic Surgery Devices

2

No

Nationwide Distribution including HI, MS, NY, OH, PA, VA, WA, WV, and IL.

The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate, distend, and debride while warming the fluid to assist in the prevention of peri-operative hypothermia. The fluid is warmed via an internal infrared mechanism. Additionally the system will hold suction canisters for the collection of used irrigant.