BEUDAMED
    FDA Enforcement Class II Ongoing

    Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY

    Recall: Z-0486-2024 · Reported December 13, 2023

    Enforcement

    Recall Number
    Z-0486-2024
    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: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY

    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: 20650862113017. Lots: 461817, 467572, 467572, 468617, 468855, 467191, 467849, 469401, 479253.

    Distribution

    US: VA