Reported Sep 3, 2014 · Terminated
The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate, distend, and debride while…
Thermedx LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Thermedx LLC · 31200 Solon Rd · Solon, OH · 44139-3556
Is this the product you have?
- 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.
- Lot codes and dates
- Model P4000 Serial numbers affected
2011000420110007201100152011002520130001-2013003220140001-20140005
- Model P4000 Serial numbers affected
- Amount recalled
- 21
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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