BEUDAMED
    FDA Recall Terminated

    REMstar Heated Humidifer Main PCA Repair Kit, Part number 1006265

    Recall: Z-0447-2007 · Initiated October 25, 2006

    Recall

    Recall Number
    Z-0447-2007
    Event Number
    36649
    Firm
    Respironics, Inc.
    FEI Number
    2518422
    Product Code
    BTT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 25, 2006
    Posted
    January 10, 2007
    Terminated
    December 15, 2009
    Address
    1001 Murry Ridge Ln, Murrysville, PA, 15668-8550

    Description

    REMstar Heated Humidifer Main PCA Repair Kit, Part number 1006265

    Reason

    AC inlet connector failure that can result in thermal damage to the humidifier enclosure and/or ignition of materials external to the device

    Action

    The recalling firm issued a recall letter dated 10/25/06 to their domestic and Canadian dealers informing them of the problem and the need to contact the end users. These dealers were given two options: 1) contact the end user by forwarding a letter the recalling firm provided or 2) contacting the third party company with their distribution list. The recalling firm issued a recall letter dated 10/25/06 regarding the service repair kit and the need to contact end users that had the device repaired using this kit. The recalling firm issued a recall letter date 10/25/06 to the international customers informing them of the problem, contact the end users, and the need to destroy the recalled part.

    Distribution

    Worldwide Distribution ---- including USA and countries of Denmark, Austria, France, Canada, Netherlands, Japan, Hong Kong, Austrailia, Great Britain, Spain, Belgium, Germany, Poland, Ireland, Portugal, Saudia Arabia, Korea, Mexico, Finland, Taiwan, Philippines, Iceland, Brazil, Kuwait, New Zealand, Chile, India, Egypt, Norway, Turkey, Jordan, Thailand, Hungary, Russia, Peru, South Africia, Israel, Czech, Pakistan, Lebanon, Venezuela, Sweden, United Arab Emirates, Qatar, Slovakia, Bulgaria, Bermuda, and Colombia.

    Quantity

    235 units