BEUDAMED
    FDA Enforcement Class II Terminated

    Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the human vasculature.

    Recall: Z-2033-2017 · Reported May 10, 2017

    Enforcement

    Recall Number
    Z-2033-2017
    Event ID
    76939
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Terumo Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 10, 2017
    Initiation Date
    November 6, 2015
    Classification Date
    May 4, 2017
    Termination Date
    May 12, 2017
    Address
    950 Elkton Blvd, Elkton, MD, 21921-5322, United States

    Description

    Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the human vasculature.

    Reason

    Based on internal investigation and testing that revealed the distal end of certain lots of Terumo Medical Destination¿ products may not contain the labeled 5 cm of coating. While there have been no complaints or patient related incidents reported, the lack of coating could render it difficult to navigate the device to the target vasculature.

    Code Info

    Terumo Product Code - RSR01 Affected Lot Numbers RN19 RN26 RP03

    Distribution

    Nationwide Distribution.

    Quantity

    5,252 eaches