BEUDAMED
    FDA Enforcement Class II Ongoing

    NexSite HD, Hemodialysis Symmetric Tip Catheter for long term use

    Recall: Z-1699-2021 · Reported June 9, 2021

    Enforcement

    Recall Number
    Z-1699-2021
    Event ID
    87827
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MARVAO MEDICAL DEVICES LTD.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 9, 2021
    Initiation Date
    February 11, 2020
    Classification Date
    June 1, 2021
    Address
    Unit 1 Galway Business Park, Dangan, Galway, N/A, Ireland

    Description

    NexSite HD, Hemodialysis Symmetric Tip Catheter for long term use

    Reason

    The action is to ensure consistency between the Directions for Use (DFU) in the field and the DFU on the website.

    Code Info

    Model Number/Product Description/Lot Number: NEXHDSY1551901/NexSite HD Symmetric Tip Catheter 19cm/51377; NEXHDSY1552301/NexSite HD Symmetric Tip Catheter 23cm/51378; NEXHDSY1555501/NexSite HD Symmetric Tip Catheter 55cm/51380; NEXHDSY1552701/NexSite HD Symmetric Tip Catheter 27cm/51435;

    Distribution

    U.S.: CO, NC, SC, TX, O.U.S.: Not provided

    Quantity

    292 devices