FDAFDA · Food and drugs·Recall number Z-2555-2014
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.
Published September 3, 2014 · Recall initiated: February 10, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Thermedx LLC
- Distributor
- Nationwide Distribution including HI, MS, NY, OH, PA, VA, WA, WV, and IL.
- Lot
- Model P4000 Serial numbers affected: 20110004, 20110007, 20110015, 20110025, 20130001-20130032, 20140001-20140005
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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