BEUDAMED
    FDA Recall Open, Classified

    Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software Version: N/A Product Description: AirLife Infant Heated Wire Circuit dual-limb, dual-heat, high-flow circuit (>4 L/min) Component: No. a conduit for respiratory gas between the patient and a ventilator.

    Recall: Z-1697-2025 · Initiated April 10, 2025

    Recall

    Recall Number
    Z-1697-2025
    Event Number
    96664
    Firm
    Vyaire Medical
    FEI Number
    3013421741
    Product Code
    BZE
    Status
    Open, Classified
    Root Cause
    Component design/selection
    Initiated
    April 10, 2025
    Posted
    May 9, 2025
    Address
    26125 N Riverwoods Blvd, Mettawa, IL, 60045-3420

    Description

    Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software Version: N/A Product Description: AirLife Infant Heated Wire Circuit dual-limb, dual-heat, high-flow circuit (>4 L/min) Component: No. a conduit for respiratory gas between the patient and a ventilator.

    Reason

    Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, including hypoxia, hypercapnia, and organ failure.

    Action

    On April 10, 2025, the firm notified customers via emailed letters titled URGENT: MEDICAL DEVICE RECALL. Customers are instructed to examine their inventory for the affected lots of product. Product in inventory should be quarantined. For in-use product - 1) For affected product in use that is utilizing the adaptor connection, immediately stop use of the product. 2) For affected product in use that is not utilizing the adaptor connection, ventilator circuit may continue to be utilized. Customers were provided with additional precautions to take to ensure proper function. Customers can choose between returning or destroying affected product. Firm will provide replacement product. If you have any questions regarding this field action, please call AirLife at 1-800-433-2797, or e-mail at [email protected].

    Distribution

    Worldwide distribution - US Nationwide and the countries of Germany, Poland, Belgium, Spain, Romania, UK, Italy, Netherlands, India, Slovenia, Qatar, and Saudi Arabia.

    Quantity

    1895