BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2550-2016 · Initiated July 12, 2016

    Recall

    Recall Number
    Z-2550-2016
    Event Number
    74736
    Firm
    Resmed Corporation
    FEI Number
    1000115734
    Product Code
    BZD
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    July 12, 2016
    Terminated
    September 26, 2016
    Address
    9001 Spectrum Center Blvd, San Diego, CA, 92123-1438

    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.

    Action

    An urgent product recall notification letter was sent to all customers on 7/12/16 to inform them that ResMed is recalling NV Quattro Air & Quattro Air Mask due to a mislabeling Issue. The letter informs the customers that during the investigation of a product complaint, ResMed identified that a small number of masks labelled and sold as 62702 Quattro Air FFM MED AMER, Lot 1142623 actually contain an NV Quattro Air FFM Large mask. The letter informs the customers to notify anyone they may have sold the products to. Customers with any questions are instructed to call the ResMed Customer Service team: 858-836-5968.

    Distribution

    US nationwide distribution

    Quantity

    42 units