BEUDAMED
    FDA Recall Terminated

    Concha IV Plus Heated Humidifier

    Recall: Z-0929-04 · Initiated April 20, 2004

    Recall

    Recall Number
    Z-0929-04
    Event Number
    28916
    Firm
    Hudson Respiratory Care Inc
    FEI Number
    2014730
    Product Code
    BTT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 20, 2004
    Posted
    July 20, 2004
    Terminated
    January 18, 2005
    Address
    27711 Diaz Rd, Temecula, CA, 92590-3425

    Description

    Concha IV Plus Heated Humidifier

    Reason

    Software malfunction. The humidifier did not retain the clinician selected default settings for temperature gradient, after the unit had been placed in the "pause" mode.

    Action

    Firm will call hospitals to arrange for a visit to update the software.

    Distribution

    Nationwide.

    Quantity

    1049