BEUDAMED
    FDA Recall Terminated

    Aqua 540 SW, 540 w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.

    Recall: Z-2010-2014 · Initiated June 5, 2014

    Recall

    Recall Number
    Z-2010-2014
    Event Number
    68493
    Firm
    Teleflex Medical
    FEI Number
    3005747797
    Product Code
    BTT
    Status
    Terminated
    Root Cause
    Packaging change control
    Initiated
    June 5, 2014
    Posted
    July 7, 2014
    Terminated
    July 2, 2015
    Address
    4024 Stirrup Creek Dr, Durham, NC, 27703-9000

    Description

    Aqua 540 SW, 540 w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.

    Reason

    The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

    Action

    Consignees were notified by letter on 06/06/2014.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand and Zambia.

    Quantity

    7,758,650 ea. (total for all types listed)