BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated September 5, 2023

    Recall

    Recall Number
    Z-0486-2024
    Event Number
    93343
    Firm
    Atrium Medical Corporation
    FEI Number
    3011175548
    Product Code
    CAC
    Status
    Open, Classified
    Root Cause
    Labeling mix-ups
    Initiated
    September 5, 2023
    Posted
    December 2, 2023
    Address
    40 Continental Blvd, Merrimack, NH, 03054-4332

    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.

    Action

    The recall notification was issued via Fed-Ex and email on October 5, 2023. It requests (1) immediate quarantine and return of all affected product inventory on hand. (2) for any product further distributed, notify customers that have received affected product to remove the affected devices from use and return them. Questions may be addressed to your Getinge representative or call Getinge Customer Support at (603) 880-1433 (press option 1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).

    Distribution

    US: VA