BEUDAMED
    FDA Enforcement Class I Ongoing

    Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system.

    Recall: Z-1637-2026 · Reported April 8, 2026

    Enforcement

    Recall Number
    Z-1637-2026
    Event ID
    98458
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    April 8, 2026
    Initiation Date
    February 18, 2026
    Classification Date
    April 1, 2026
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625, United States

    Description

    Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system.

    Reason

    Urgent Medical Device Correction for the Volara system single-patient use circuit due to the potential that patients or caregivers may be unaware of a possible decrease in oxygen levels (oxygen desaturation), or potential lung tissue injury from overexpansion (barotrauma) when the Volara device is used in the home care environment. This correction is providing the home caregiver specific instructions for use.

    Code Info

    UDI/DI number 00887761984622

    Distribution

    Florida

    Quantity

    19 units