BEUDAMED
    FDA Enforcement Class II Ongoing

    VariSoft Infusion Set, Single Use.

    Recall: Z-3186-2024 · Reported September 25, 2024

    Enforcement

    Recall Number
    Z-3186-2024
    Event ID
    95224
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Unomedical A/S
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    September 25, 2024
    Initiation Date
    July 23, 2024
    Classification Date
    September 19, 2024
    Address
    Osted, Aholmvej 1 - 3, Lejre, N/A, Denmark

    Description

    VariSoft Infusion Set, Single Use.

    Reason

    Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded "Trusteel Infusion Set".

    Code Info

    UDI-DI: 05705244018747. Product Code: 1726035. Lot Number: 6005241

    Distribution

    US Nationwide distribution in the state of California.