BEUDAMED
    FDA Recall Terminated

    Teleflex Medical Hudson RCI ConchaTherm Neptune Heated Humidifier, Rx Only.

    Recall: Z-1558-2015 · Initiated April 1, 2015

    Recall

    Recall Number
    Z-1558-2015
    Event Number
    70895
    Firm
    Teleflex Medical
    FEI Number
    3005747797
    Product Code
    BTT
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 1, 2015
    Posted
    April 30, 2015
    Terminated
    March 5, 2025
    Address
    2917 Weck Dr, Research Triangle Park, NC, 27709-0186

    Description

    Teleflex Medical Hudson RCI ConchaTherm Neptune Heated Humidifier, Rx Only.

    Reason

    Customer complaints were received of power to the unit ceasing and the display going blank.

    Action

    Teleflex sent an Urgent - Medical Device Notification letter dated April 1, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. They were informed that Teleflex Medical would exchange all of the potentially impacted units in the field with the Neptune Heated Humidifier with ConchaSmart" Technology. In the meantime, they were instructed to continue to follow hospital and departmental protocol regarding the regular monitoring of the patient and the product during treatment. If the unit display is blank, replace it with another unit and call Teleflex for an immediate replacement. A Recall Acknowledgement Form was attached to be completed, scanned and returned to Teleflex Medical to document receipt of this Notification. Teleflex Medical is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-396-2111.

    Distribution

    US Nationwide and Internationally to the countries of: Belgium and Japan

    Quantity

    7,228 units