BEUDAMED
    FDA Enforcement Class I Ongoing

    Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinTube sample line 240cm is used in the Vyntus CPX. The TwinTube sample line 240cm is connected to the adapter for DVT. Twin Tube Probenschlauch (707004), which is sold outside the US only. Used in breath analysis for metabolic response study.

    Recall: Z-1730-2024 · Reported May 15, 2024

    Enforcement

    Recall Number
    Z-1730-2024
    Event ID
    94256
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Vyaire Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 15, 2024
    Initiation Date
    April 8, 2024
    Classification Date
    May 8, 2024
    Address
    Leibnizstr. 7, N/A, Hochberg, N/A, N/A, Germany

    Description

    Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinTube sample line 240cm is used in the Vyntus CPX. The TwinTube sample line 240cm is connected to the adapter for DVT. Twin Tube Probenschlauch (707004), which is sold outside the US only. Used in breath analysis for metabolic response study.

    Reason

    Potential of the nozzle separating during patient use.

    Code Info

    UDI/DI 14250892903603, All lots prior to June 2023 or with a serial number before 04I00122 are potentially affected.

    Distribution

    US nationwide distribution.

    Quantity

    649 devices