BEUDAMED
    FDA Enforcement Class I Ongoing

    VariSoft infusion set, Model Number 1002830

    Recall: Z-0234-2024 · Reported November 29, 2023

    Enforcement

    Recall Number
    Z-0234-2024
    Event ID
    93269
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Unomedical A/S
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 29, 2023
    Initiation Date
    October 11, 2023
    Classification Date
    November 20, 2023
    Address
    Aaholmvej 1 - 3, OSTED, LEJRE, N/A, N/A, Denmark

    Description

    VariSoft infusion set, Model Number 1002830

    Reason

    The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage to the connector piece during manufacturing. This damage results in the connector becoming detached more easily from the insulin set than expected, requiring less force to disconnect than intended. Disconnection, when not detected, for example during sleep, leads to missed basal dosing. which in turn can result in elevated blood glucose and ketone level (nocturnal hyperglycemia). Diabetic ketoacidosis.

    Code Info

    GTIN 05705244018792, Serial Numbers: 5388368; GTIN 05705244018785, Serial Numbers: 5388368

    Distribution

    US Nationwide distribution in the state of CA.

    Quantity

    3362 units