BEUDAMED
    FDA Recall Terminated

    Atrium Medical Dual Chamber Ocean Drains as follows: 2020-000 Ocean dual chamber, in-line connectors and suction control stopcock (2 Patient Tubes) 2020-100 Ocean dual chamber with in-line connectors and no suction control stopcock (2 Patient Tubes) 2020-300 Ocean dual chamber with suction control stopcock, no in-line connector (2 Patient Tubes) Product Usage: 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 patient s pleural cavity or mediastinal area.

    Recall: Z-1080-2017 · Initiated November 29, 2016

    Recall

    Recall Number
    Z-1080-2017
    Event Number
    75599
    Firm
    Atrium Medical Corporation
    FEI Number
    3011175548
    Product Code
    PAD
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    November 29, 2016
    Terminated
    September 29, 2020
    Address
    5 Wentworth Dr, Hudson, NH, 03051-4929

    Description

    Atrium Medical Dual Chamber Ocean Drains as follows: 2020-000 Ocean dual chamber, in-line connectors and suction control stopcock (2 Patient Tubes) 2020-100 Ocean dual chamber with in-line connectors and no suction control stopcock (2 Patient Tubes) 2020-300 Ocean dual chamber with suction control stopcock, no in-line connector (2 Patient Tubes) Product Usage: 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 patient s pleural cavity or mediastinal area.

    Reason

    Outer Packaging is not sterile

    Action

    Atrium Medical issued recall letter on 11/29/16 via two-day express mail delivery advising users: of the problem, updated instructions for use; the new Warning Label applied to the packaging; and requesting to post the warning label near all Atrium chest drain product inventory. A Field Notification Reply Form acknowledging receipt of the Field Notification was requested to be completed and returned. Questions contact 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).

    Distribution

    Worldwide Distribution - US Nationwide and the countries of Algeria, Australia, Austria, Belgium, Brazil, Canada, Chile, China, China, Columbia, Ecuador, Egypt, Finland, France, Germany, Great Britain, Greece, Guatemala, Hong Kong, Ireland, Italy, Kuwait, Lebanon, Libya, Mexico, Netherlands, New Zealand, Pakistan, Panama, Peru, Poland, Portugal, Puerto Rico, Saudi Arabia, South Korea, Spain, Sweden, Thailand, Tunisia, and Venezuela,

    Quantity

    964,463 cases (US) 521,975 cases (OUS) in total