BEUDAMED
    FDA Enforcement Class II Completed

    vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)

    Recall: Z-0489-2024 · Reported December 13, 2023

    Enforcement

    Recall Number
    Z-0489-2024
    Event ID
    93332
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Vyaire Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 13, 2023
    Initiation Date
    October 27, 2023
    Classification Date
    December 5, 2023
    Address
    26125 N Riverwoods Blvd, Mettawa, IL, 60045-3420, United States

    Description

    vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)

    Reason

    Two patient circuits, 29028-003 and 29028-004, for the 3100 High Frequency Oscillatory ventilator that are only approved for use outside the U.S. were distributed in the U.S.

    Code Info

    UDI/DI 10190752155251: Lot/serial numbers: 4022993, 4160569, 4160570, 4163199, 4163200, 4165472, 4166359, 4231715, 4243198, 4253792

    Distribution

    US: Florida

    Quantity

    16 circuits