BEUDAMED
    FDA Enforcement Class II Terminated

    Navigator HD l3F/15F x 46cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog M0062502290, 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-0442-2014 · Reported December 11, 2013

    Enforcement

    Recall Number
    Z-0442-2014
    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 46cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog M0062502290, 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 M0062502290, Catalog 250-229, 15579545, 15579546, 15615465, 15630771, 15630772, 15688533, 15688534, 15813601, 15823202, 15880464, 15927981, 16159896, 16175942, 16196763, 16373048,

    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

    449