BEUDAMED
    FDA Enforcement Class II Terminated

    Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System with stopcock and in-line connectors Sterile fluid path packaging Product Code: 2050-070. To evacuate air and/or fluid from the chest cavity or mediastinum.

    Recall: Z-0736-2014 · Reported January 22, 2014

    Enforcement

    Recall Number
    Z-0736-2014
    Event ID
    66788
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Atrium Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 22, 2014
    Initiation Date
    November 19, 2013
    Classification Date
    January 14, 2014
    Termination Date
    June 11, 2015
    Address
    5 Wentworth Dr, Hudson, NH, 03051-4929, United States

    Description

    Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System with stopcock and in-line connectors Sterile fluid path packaging Product Code: 2050-070. To evacuate air and/or fluid from the chest cavity or mediastinum.

    Reason

    Chest Drain tubing of of the ATS Blood recovery may leak or disconnect

    Code Info

    Lot number starting with 10883097 and the ending lot number 10913346. (All units in between and including these two numbers). To evacuate air and/or fluid from the chest cavity or mediastinum.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.

    Quantity

    624 units