BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-0235-2023 · Reported November 23, 2022

    Enforcement

    Recall Number
    Z-0235-2023
    Event ID
    91043
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Atrium Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 23, 2022
    Initiation Date
    October 18, 2022
    Classification Date
    November 15, 2022
    Address
    40 Continental Blvd, N/A, Merrimack, NH, 03054-4332, United States

    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.

    Code Info

    UDI-DI: 20650862100017 - case / 00650862100013- each Lot Number: 472326, 473226

    Distribution

    US Nationwide distribution in the state of VA.

    Quantity

    24 units (4cases/6)