BEUDAMED
    FDA Enforcement Class II Terminated

    Quattro Air FFM MED  AMER, Product Code: 62702, full face mask for use with active-exhaust-valve ventilators

    Recall: Z-2550-2016 · Reported August 24, 2016

    Enforcement

    Recall Number
    Z-2550-2016
    Event ID
    74736
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Resmed Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 24, 2016
    Initiation Date
    July 12, 2016
    Classification Date
    August 16, 2016
    Termination Date
    September 26, 2016
    Address
    9001 Spectrum Center Blvd, N/A, San Diego, CA, 92123-1438, United States

    Description

    Quattro Air FFM MED  AMER, Product Code: 62702, full face mask for use with active-exhaust-valve ventilators

    Reason

    Masks in this lot, labelled and sold as 62702 vented Quattro Air FFM size Medium actually contain a non-vented (NV) Quattro Air FFM Large mask.

    Code Info

    Lot 1142623

    Distribution

    US nationwide distribution

    Quantity

    42 units