Thermedx LLC: Medical Device Recall in 2014 - (Recall #: Z-2555-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: February 10, 2014

Date Posted: September 3, 2014

Recall Number: Z-2555-2014

Event ID: 68986

Reason for Recall:

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.

Status: Terminated

Product Quantity: 21

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated