BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-2555-2014 · Reported September 3, 2014

    Enforcement

    Recall Number
    Z-2555-2014
    Event ID
    68986
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Thermedx LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 3, 2014
    Initiation Date
    February 10, 2014
    Classification Date
    August 27, 2014
    Termination Date
    August 4, 2015
    Address
    31200 Solon Rd, Unit 1, Solon, OH, 44139-3556, United States

    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.

    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 Info

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

    Distribution

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

    Quantity

    21