BEUDAMED
    FDA Enforcement Class II Ongoing

    Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION.

    Recall: Z-0485-2024 · Reported December 13, 2023

    Enforcement

    Recall Number
    Z-0485-2024
    Event ID
    93343
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Atrium Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 13, 2023
    Initiation Date
    September 5, 2023
    Classification Date
    December 1, 2023
    Address
    40 Continental Blvd, Merrimack, NH, 03054-4332, United States

    Description

    Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION.

    Reason

    Product was re-processed and re-sterilized by a third party using packaging configurations and a sterilization process which are not approved by the manufacture and lack validation.

    Code Info

    UDI-DI: 20650862110016. Lots: 460793, 461324, 463567, 463568, 463569, 466447, 466945, 466946, 467473, 467843, 471055, 471797, 472571, 474505, 477919, 480204, 480205, 480658, 482038, 483030, 483794, 484519, 484521, 484530, 486156, 486531, 487059, 488305, 489762.

    Distribution

    US: VA