BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1544-2024 · Initiated March 5, 2024

    Recall

    Recall Number
    Z-1544-2024
    Event Number
    94217
    Firm
    Unomedical A/S Osted Aholmvej 1
    FEI Number
    1000477110
    Product Code
    FPA
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    March 5, 2024
    Posted
    April 15, 2024
    Address
    3 Lejre 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.

    Action

    Unomedical a/s issued an URGENT: VOLUNTARY MEDICAL DEVICE RECALL notice to its sole consignee on 03/05/2024 via email. The notice explained the issue and requested they examine their inventory for affected product and quarantine it pending destruction. The consignee was also directed to notify their customers.

    Distribution

    US Nationwide distribution in the state of Florida.

    Quantity

    10,770 units