BEUDAMED
    FDA Enforcement Class I Ongoing

    Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH265 Software Version: N/A Product Description: AirLife Infant Heated Wire Circuit Kit Dual-limb, Dual-heat, high-flow circuit (>4 L/min) Contains AH165 Circuit, AH290 Chamber Component: No. a conduit for respiratory gas between the patient and a ventilator.

    Recall: Z-1698-2025 · Reported May 21, 2025

    Enforcement

    Recall Number
    Z-1698-2025
    Event ID
    96664
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Vyaire Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 21, 2025
    Initiation Date
    April 10, 2025
    Classification Date
    May 9, 2025
    Address
    26125 N Riverwoods Blvd, Mettawa, IL, 60045-3420, United States

    Description

    Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH265 Software Version: N/A Product Description: AirLife Infant Heated Wire Circuit Kit Dual-limb, Dual-heat, high-flow circuit (>4 L/min) Contains AH165 Circuit, AH290 Chamber 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.

    Code Info

    Lot Code: Lot/Serial Number(s): 0004247924 0004247925 0004252940 0004252941 0004256292 0004256293 0004256294 0004256295 0004272325 0004272868 0004278978 0004279156 0004280036 0004285304 0004288036 0004289514 UDI-DI: AirLife Label Each: 10889483595909 Case: 30889483595903 Vyaire Label: Each: 10190752145160 Case: 50190752145168

    Distribution

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

    Quantity

    3053