BEUDAMED
    FDA Recall Open, Classified

    Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000

    Recall: Z-0235-2023 · Initiated October 18, 2022

    Recall

    Recall Number
    Z-0235-2023
    Event Number
    91043
    Firm
    Atrium Medical Corporation
    FEI Number
    3011175548
    Product Code
    KDQ
    Status
    Open, Classified
    Root Cause
    Storage
    Initiated
    October 18, 2022
    Posted
    November 15, 2022
    Address
    40 Continental Blvd, Merrimack, NH, 03054-4332

    Description

    Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000

    Reason

    Warehouse experienced temperature excursions in July and August 2021. It was determined that there were no associated harms to patients.

    Action

    Atrium/ Getinge issued Urgent Medical Device Removal on 10/18/21 via email with Delivery and Read receipt. Letter states reason for recall, health risk and action to take: Our records indicate that McKesson has received the Atrium Ocean Wet Suction Water Seal Chest Drains from the lot listed on Page 1. " Please examine your inventory and confirm that you have no remaining Atrium Ocean Wet Suction Water Seal Chest Drain 2002-000 with the REF/LOT number listed in this notice. Please return any product that may be affected under this Field Action. " Please respond to this email using the response form on page 3 to acknowledge that you have received this notification. If you have any questions, please contact your Atrium/Getinge representative or call the Atrium/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 Nationwide distribution in the state of VA.

    Quantity

    24 units (4cases/6)