BEUDAMED
    FDA Recall Open, Classified

    Express Mini 500 Dry Seal Chest Drain, Part Number 16400

    Recall: Z-1303-2023 · Initiated March 1, 2023

    Recall

    Recall Number
    Z-1303-2023
    Event Number
    91718
    Firm
    Atrium Medical Corporation
    FEI Number
    3011175548
    Product Code
    KDQ
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 1, 2023
    Posted
    March 30, 2023
    Address
    40 Continental Blvd, Merrimack, NH, 03054-4332

    Description

    Express Mini 500 Dry Seal Chest Drain, Part Number 16400

    Reason

    The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry Seal Chest Drains do not provide sufficient precaution against draining the device for continued use. Additionally, the IFUs do not provide sufficient precaution or warning against the use of the device outside the healthcare setting.

    Action

    Urgent Medical Device Correction letters dated 3/1/23 were sent to customers. Updated Instructions New Warning and Precautions: The facility can continue use of the product with the IFU that was provided along with the consideration of the following: " NEW and Applicable Existing Warnings and Precautions for Express Mini 500: o NEW Warning: The Express Mini 500 is restricted for use by trained healthcare providers familiar with cardiothoracic surgical procedures and techniques, including the use of chest drains. o NEW Precaution: The Express Mini 500 is restricted for use in a healthcare facility. The Express Mini 500 should not be used for outpatient drainage. o NEW Precaution: Use of the Luer port is intended only for sampling patient drainage. Do not use the Luer port or any other means to empty fluid from the collection chamber. o Existing Precaution: Replace chest drain if damaged or when collection volume meets or exceeds maximum capacity. Actions to be Taken by the Customer: " Please ensure that all Atrium Express Mini 500 Dry Seal Chest Drain users at your facility are aware of this Safety Notice and post a copy of the Notice on Page 3 in all inventory locations within your facility where the devices are stored. Your facility can continue use of the device. No devices need to be returned. " Please forward this information to all current and potential Atrium Express Mini 500 Dry Seal Chest Drain users within your hospital / facility. " If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. " Please complete and sign the attached URGENT: MEDICAL DEVICE CORRECTION - RESPONSE FORM on Page 4 to acknowledge that you have received this notification. Return the completed form to Atrium/Getinge by emailing a scanned copy of the completed form to [email protected] or or by faxing the form to (866)-308-8040. Type of Action Taken by Getinge: Atrium

    Distribution

    Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Colombia, Czech Republic, Germany, Ecuador, Estonia, Spain, Finland, France, United Kingdom, Hong Kong, Indonesia, Ireland, Israel, Iceland, Italy, Jordan, South Korea, Kuwait, Luxembourg, Mexico, Malaysia, Netherlands, Norway, New Zealand, Peru, Philippines, Poland, Portugal, Sweden, Singapore, Slovenia, Thailand.

    Quantity

    8184 cases of 6