BEUDAMED
    FDA Enforcement Class I Terminated

    Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient.

    Recall: Z-0621-2013 · Reported January 9, 2013

    Enforcement

    Recall Number
    Z-0621-2013
    Event ID
    63794
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Fisher & Paykel Healthcare, Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 9, 2013
    Initiation Date
    November 19, 2012
    Classification Date
    January 3, 2013
    Termination Date
    July 11, 2013
    Address
    15 Marcel Place, East Tamaki, North Shore City, N/A, N/A, New Zealand

    Description

    Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient.

    Reason

    FPH has become aware that one batch of tubes supplied to FPH may contain hole damage. These tubes were incorporated by FPH into certain 900MR068 reusable circuits with lot numbers 110810 and 111020. If this hole damage is not detected during the standard leak test before patient use, it could potentially result in a gas leak in the breathing system, which may lead to a loss of pressure for the int

    Code Info

    Lots 110810 and 111020

    Distribution

    Worldwide Distribution - USA including IL, IN, AR and GA.

    Quantity

    200 units total, 26 units US