BEUDAMED
    FDA Enforcement Class I Ongoing

    Volara System. Blue Ventilator Adapter Module. Intermittent positive pressure breathing device component.

    Recall: Z-2322-2024 · Reported July 24, 2024

    Enforcement

    Recall Number
    Z-2322-2024
    Event ID
    94713
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 24, 2024
    Initiation Date
    May 30, 2024
    Classification Date
    July 17, 2024
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625, United States

    Description

    Volara System. Blue Ventilator Adapter Module. Intermittent positive pressure breathing device component.

    Reason

    Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow.

    Code Info

    Product Code: M07937; Lot numbers: 4210495, 4325617.

    Distribution

    Nationwide distribution. International distribution to Canada, France, and Germany.

    Quantity

    350 units