BEUDAMED
    FDA Enforcement Class II Terminated

    Navigator HD l3F/15F x 36cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog No 250-228, Sterile. Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.

    Recall: Z-0441-2014 · Reported December 11, 2013

    Enforcement

    Recall Number
    Z-0441-2014
    Event ID
    66828
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 11, 2013
    Initiation Date
    November 5, 2013
    Classification Date
    December 4, 2013
    Termination Date
    December 8, 2014
    Address
    100 Boston Scientific Way, N/A, Marlborough, MA, 01752-1234, United States

    Description

    Navigator HD l3F/15F x 36cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog No 250-228, Sterile. Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.

    Reason

    The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports where the tip of the dilator has separated fro the body of the dilator.

    Code Info

    UPN M0062502280, Catalog 250-228, Lot 15753725,15819257,15840833,1587719, 15918445,15931128, 16008343,16015286, 16065866,16141201, 16295107,16319657

    Distribution

    Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Ireland, Denmark, Italy, France, Canada, Great Britain, Switzerland, South Africa, Germany, and the Netherlands.

    Quantity

    939