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Recall Observatory FDA recall evidence

Device 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 hold suction canisters for the collection of used irrigant.

Z-2555-2014

February 10, 2014

Class II

Product summary

Firm
Thermedx LLC
Event
Event 68986
Status
Terminated
Classification
Class II
Quantity
21
Official record key
device-enforcement:Z-2555-2014

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.