BEUDAMED
    FDA Enforcement Class II Ongoing

    Neria Soft Infusion Set, Product Code 507302, intravascular administration set

    Recall: Z-1544-2024 · Reported April 24, 2024

    Enforcement

    Recall Number
    Z-1544-2024
    Event ID
    94217
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Unomedical A/S
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 24, 2024
    Initiation Date
    March 5, 2024
    Classification Date
    April 15, 2024
    Address
    Osted, Aholmvej 1 - 3, Lejre, N/A, Denmark

    Description

    Neria Soft Infusion Set, Product Code 507302, intravascular administration set

    Reason

    Specific lots of Neria Soft Infusion Sets, which have been shipped into the US Market, have been shipped with the incorrect Instruction for Use (IFU) within the final pack. The IFU included is the IFU registered for the Rest of World (ROW) countries. The difference between the US IFU and the ROW IFU is the addition of an intended use section in the ROW IFU.

    Code Info

    UDI/DI 05705244001558, Lot Numbers: 5277396, 5371146

    Distribution

    US Nationwide distribution in the state of Florida.

    Quantity

    10,770 units