BEUDAMED
    FDA Recall Terminated

    Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE Reference: 2002-400 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-1210-2017 · Initiated December 23, 2016

    Recall

    Recall Number
    Z-1210-2017
    Event Number
    75707
    Firm
    Atrium Medical Corporation
    FEI Number
    3011175548
    Product Code
    KDQ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 23, 2016
    Terminated
    November 3, 2020
    Address
    5 Wentworth Dr, Hudson, NH, 03051-4929

    Description

    Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE Reference: 2002-400 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.

    Action

    Maquet issued a Field action correction notification sent to customers on 12/23/16 via Fed'x for delivery on Tuesday Dec.27, 2016.who have received affected product and describes the failure mode. Accounts to complete the enclosed Field Notification Reply Form to acknowledge receipt of the notification. Return the Field Notification Reply Form to the following e-mail address: [email protected] or you may fax the form to 1-603-386-6590. Questions, contact your local Atrium/Maquet/Getinge chest drainage representative or Atrium Customer Service at 1-800-528-7486 (603-880-1433), Monday through Friday between 8:00 am and 5:00 pm (EST). UPDATE: On 1/16/17, Maquet issued recall letters that identified correct lot numbers and products in the letter titles: UPDATE-UPDATED AFFECTED DEVICES. Two letters issued one to customers who received the Dec 23 letter and one to new customers who who did not receive the Dec. 23 letter.

    Distribution

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

    Quantity

    1 case (6 units)