BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-2010-2014 · Reported July 16, 2014

    Enforcement

    Recall Number
    Z-2010-2014
    Event ID
    68493
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Teleflex Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 16, 2014
    Initiation Date
    June 5, 2014
    Classification Date
    July 7, 2014
    Termination Date
    July 2, 2015
    Address
    4024 Stirrup Creek Dr, Durham, NC, 27703-9000, United States

    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.

    Code Info

    Product Code: 005-40, Lot numbers: 001125, 002125, 003125, 004125, 005125, 006125, 007125, 008125, 009125, 010125, 011125, 012125, 013125, 014125, 015125, 016125, 017125, 019125, 020125, 021125, 022125, 023125, 024125, 025125, 026125 & 032125.

    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)