BEUDAMED
    FDA Enforcement Class II Terminated

    The Hulka Clip is a sterile packaged medical device that carries a two year expiration date. It is packaged two clips per procedural tray. Theses procedural trays are then sealed in a Tyvek/Mylar pouch and packaged in a cardboard shipping carton with ten pouches in each shipping carton.

    Recall: Z-0037-2015 · Reported October 15, 2014

    Enforcement

    Recall Number
    Z-0037-2015
    Event ID
    68777
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Richard Wolf Medical Instruments Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 15, 2014
    Initiation Date
    July 9, 2014
    Classification Date
    October 7, 2014
    Termination Date
    April 24, 2017
    Address
    353 Corporate Woods Pkwy, Vernon Hills, IL, 60061-3110, United States

    Description

    The Hulka Clip is a sterile packaged medical device that carries a two year expiration date. It is packaged two clips per procedural tray. Theses procedural trays are then sealed in a Tyvek/Mylar pouch and packaged in a cardboard shipping carton with ten pouches in each shipping carton.

    Reason

    Richard Wolf Medical Instrument Corporation is recalling Hulka Clip Tubal Occluding Device lot 51000232. The devices are being recalled as a part of an investigation into a biocompatibility test discrepancy where the recalled lot (lot 51000232) passed final release testing, but the subsequent lot failed biocompatibility testing on a component that was also used to manufacture lot 51000232.

    Code Info

    Product Code: 4986.09; Lot: 51000232

    Distribution

    Worldwide distribution: US (Nationwide) including states of: (AK, AL, CO, CT, FL, GA, IA, IN, KY, LA, MI, MO, MS, NC, NY, OH, OR, PA, SC, TN, TX, VA, WA, WV; and country of: Germany.

    Quantity

    73 cartons (1,460 clips)