BEUDAMED
    FDA Enforcement Class II Terminated

    Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE W/S Reference: 2002-300 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and reinfusion of autologous blood from the patients pleural cavity or mediastinal area

    Recall: Z-1209-2017 · Reported February 22, 2017

    Enforcement

    Recall Number
    Z-1209-2017
    Event ID
    75707
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Atrium Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 22, 2017
    Initiation Date
    December 23, 2016
    Classification Date
    February 15, 2017
    Termination Date
    November 3, 2020
    Address
    5 Wentworth Dr, N/A, Hudson, NH, 03051-4929, United States

    Description

    Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE W/S Reference: 2002-300 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and reinfusion of autologous blood from the patients pleural cavity or mediastinal area

    Reason

    Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.

    Code Info

    Lot Number: 243295

    Distribution

    Worldwide Distribution - US (nationwide) and Internationally to Canada and Mexico

    Quantity

    1 case (6 units)