BEUDAMED
    FDA Recall Terminated

    Hudson RCI Concha Therm Neptune Humidifier, Rx Only, Product Usage: Usage: Device that is intended to add moisture to, and sometime to warm, the breathing gases for administration to a patient.

    Recall: Z-2036-2012 · Initiated June 12, 2012

    Recall

    Recall Number
    Z-2036-2012
    Event Number
    62284
    Firm
    Teleflex Medical
    FEI Number
    3005747797
    Product Code
    BTT
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 12, 2012
    Posted
    July 19, 2012
    Terminated
    January 28, 2014
    Address
    2917 Weck Dr., Research Triangle Park, NC, 27709

    Description

    Hudson RCI Concha Therm Neptune Humidifier, Rx Only, Product Usage: Usage: Device that is intended to add moisture to, and sometime to warm, the breathing gases for administration to a patient.

    Reason

    Speaker Failure. If the speaker fails and an event occurs which would generate an audio alarm, the alarm will not sound and could cause a potential delay in patient treatment.

    Action

    Teleflex sent Urgent Medical Device Notification letters dated June 12, 2012 to all affected customers. The letter identified the affected products, problem and actions to be taken. Customers were instructed to complete the enclosed Acknowledgement Form and return per the instructions provided. Once the form is received, Teleflex Medial will schedule for a technician to come to their facility and exchange the affected product. For questions call your local sales representative or Customer Service at 1-866-246-6990.

    Distribution

    Worldwide Distribution - U.S. (nationwide) and the countries of Argentina, Australia, Brazil, Canada, Chile, China, Europe, India, Japan, Mexico, South Korea, Taiwan and UK.

    Quantity

    14,794 each