BEUDAMED
    FDA Enforcement Class II Ongoing

    Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2;

    Recall: Z-0963-2025 · Reported January 29, 2025

    Enforcement

    Recall Number
    Z-0963-2025
    Event ID
    95942
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Adept Medical Ltd
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 29, 2025
    Initiation Date
    November 24, 2024
    Classification Date
    January 17, 2025
    Address
    2-6 Mc Donald Street, Morningside, Po Box 10075 Dominion Rd, Auckland, N/A, New Zealand

    Description

    Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2;

    Reason

    Lack of 510(k) clearance.

    Code Info

    Product Code: NZ3306; UDI-DI: 09421901970345 (NZ3306); Lots: 2008-1457, 2008-1525, 2009-1845, 2010-2037, 2011-2486, 2013-3120, 2013-3221, 2014-3428, 2014-3519, 2014-3615, 2015-4103, 2016-4599, 2016-5195, 2017-5591, 2017-5812, 2018-6393, 2019-7042, 2019-9076, 2013-3120, 2013-3221, 2014-3428, 2014-3519, 2014-3615, 2015-4103, 2016-4599, 2016-5195, 2017-5591, 2017-5812, 2018-6393, 2019-7042, 2019-9076, 2020-9292, 2020-9476, 2022-10874, 2023-11128, 2023-11542,

    Distribution

    US Nationwide distribution. International: Canada, New Zealand, Australia, Yemen, United Kingdom, Spain, Italy, Turkey, El Salvador, Malaysia, United Arab Emirates, Germany, Greece, Syria, Peru, Hong Kong, Turkey, Chile, Ireland.

    Quantity

    13,070 units (9090 US, 3980 OUS)