FDA-Device2014-09-03Class II
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.
Thermedx LLC
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.
Sold states
Nationwide Distribution including HI, MS, NY, OH, PA, VA, WA, WV, and IL.
Affected count
21
Manufactured in
31200 Solon Rd, Unit 1, Solon, OH, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2555-2014Don't want to check this manually?
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