BEUDAMED
    FDA Recall Open, Classified

    VariSoft infusion set, Model Number 1002830

    Recall: Z-0234-2024 · Initiated October 11, 2023

    Recall

    Recall Number
    Z-0234-2024
    Event Number
    93269
    Firm
    Unomedical A/S Aaholmvej
    FEI Number
    1000477110
    Product Code
    FPA
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    October 11, 2023
    Posted
    November 21, 2023
    Address
    3 OSTED LEJRE Denmark, 1

    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.

    Action

    Unomedical a/s issued an Urgent Field Safety Notice to its sole consignee on 10/11/2023 via email. The notice explained the issue, potential risk to patient, and requested the distributor to quarantine all affected product pending return and to notify their customers.

    Distribution

    US Nationwide distribution in the state of CA.

    Quantity

    3362 units