The Recall Desk
ModerateFDA (Devices)·Z-2555-2014·Announced 2014-09-03

Thermedx Fluid Management System Recalled for Canister Ring Manufacturing Change

Thermedx LLC is recalling 21 units of the P4000 Fluid Management System because a manufacturing change to the canister ring may cause the deficit display to read higher than the actual fluid deficit.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source describes a performance defect in the display mechanism without reporting any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity score.

Plain-English summary

Thermedx LLC is recalling 21 units of the Thermedx Fluid Management System, Model P4000. The recall is due to a change in the manufacturing process of a component used in the canister ring, which may affect the performance of the ring.

The affected serial numbers are 20110004, 20110007, 20110015, 20110025, 20130001-20130032, and 20140001-20140005. The units were distributed nationwide, including in Hawaii, Mississippi, New York, Ohio, Pennsylvania, Virginia, Washington, West Virginia, and Illinois.

The defect may cause the deficit display to show a value higher than the actual deficit when the fluid collection canister is fully loaded. 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 recalled product

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
Manufacturer
Thermedx LLC
Category
Medical Device — Surgical Irrigation
Hazard
Affected units
21

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

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

Distribution

Distributed nationwide across the United States.

The notice also names 9 states specifically:

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