BEUDAMED
    FDA Enforcement Class II Terminated

    NephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Catalog Number: M0062101600/210-160, M0062101640/210-164 Dilation of the nephrostomy tract.

    Recall: Z-1673-2013 · Reported July 17, 2013

    Enforcement

    Recall Number
    Z-1673-2013
    Event ID
    65317
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 17, 2013
    Initiation Date
    May 28, 2013
    Classification Date
    July 9, 2013
    Termination Date
    January 23, 2014
    Address
    100 Boston Scientific Way, N/A, Marlborough, MA, 01752-1234, United States

    Description

    NephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Catalog Number: M0062101600/210-160, M0062101640/210-164 Dilation of the nephrostomy tract.

    Reason

    Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter.

    Code Info

    Lot Number: 15982017, 15963887, 16034014

    Distribution

    Worldwide distribution: USA (nationwide) including states of: NJ, NY, OH, IL, MI, MD, MA and countries of: Denmark, Great Britain, and Spain.

    Quantity

    15 units