BEUDAMED
    FDA Enforcement Class II Terminated

    Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000

    Recall: Z-1935-2015 · Reported July 8, 2015

    Enforcement

    Recall Number
    Z-1935-2015
    Event ID
    71023
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Atrium Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 8, 2015
    Initiation Date
    May 7, 2015
    Classification Date
    June 29, 2015
    Termination Date
    April 26, 2016
    Address
    5 Wentworth Dr, Hudson, NH, 03051-4929, United States

    Description

    Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000

    Reason

    Chest drains have a missing o-ring

    Code Info

    Lot Number: 222511

    Distribution

    Nationwide Canada, Germany

    Quantity

    390 cases