BEUDAMED
    FDA Enforcement Class II Terminated

    Destination Guiding Sheath catheter introducer, Catalog Number: RSR06 Product Usage: The Destination¿ Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal, carotid, and peripheral arteries.

    Recall: Z-0725-2018 · Reported March 7, 2018

    Enforcement

    Recall Number
    Z-0725-2018
    Event ID
    79167
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Terumo Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 7, 2018
    Initiation Date
    September 12, 2017
    Classification Date
    February 26, 2018
    Termination Date
    August 31, 2018
    Address
    950 Elkton Blvd, N/A, Elkton, MD, 21921-5322, United States

    Description

    Destination Guiding Sheath catheter introducer, Catalog Number: RSR06 Product Usage: The Destination¿ Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal, carotid, and peripheral arteries.

    Reason

    The tucking depth feature of this catheter introducer is marginally outside the upper specification.

    Code Info

    Lot: VK09, Expiration Date: 31-Jan-2020

    Distribution

    To be added.

    Quantity

    33