Home / Recalls / Medical Devices
Thermedx LLC recalls The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate, distend, and debride while wa
Recalled September 3, 2014 · FDA recall Z-2555-2014 · Thermedx
Hazard
A vendor changed the manufacturing process of a component used in the canister ring that may affect the performance of the ring. The deficit display may be higher than the actual deficit when the fluid collection canister is fully loaded. · FDA Class II
Units
21
Sold at
Nationwide Distribution including HI, MS, NY, OH, PA, VA, WA, WV, and IL.
Description
A vendor changed the manufacturing process of a component used in the canister ring that may affect the performance of the ring. The deficit display may be higher than the actual deficit when the fluid collection canister is fully loaded.
Product
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.
Manufacturer(s)
Thermedx LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →