BEUDAMED
    FDA Enforcement Class II Terminated

    Navigator HD l3F/15F x 28 cm Ureteral Access Sheath Set Product No M0062502270, RDF Catalog No 250-227, 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-0440-2014 · Reported December 11, 2013

    Enforcement

    Recall Number
    Z-0440-2014
    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 28 cm Ureteral Access Sheath Set Product No M0062502270, RDF Catalog No 250-227, 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 M0062502270, Catalog 250-227, Lot 15708431, 15708432, 15708433, 15812875, 15836355, 15855545, 15876213 , 15896950, 15935564, 16028474, 16044445, and 16046280

    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

    274