BEUDAMED
    FDA Recall 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 · Initiated July 9, 2014

    Recall

    Recall Number
    Z-0037-2015
    Event Number
    68777
    Firm
    Richard Wolf Medical Instruments Corp.
    FEI Number
    1418479
    Product Code
    KNH
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 9, 2014
    Posted
    November 6, 2014
    Terminated
    April 24, 2017
    Address
    353 Corporate Woods Pkwy, Vernon Hills, IL, 60061-3110

    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.

    Action

    "Urgent: Medical Device Recall" letters dated July 9, 2014 were sent to all direct accounts (customers). The letters included instructions for customers to: 1) inspect their inventories for the recalled products; 2) contact Richard Wolf Medical Instruments at 800-323-9653 x 225 or 380 to notify Richard Wolf Medical Instruments if you have any devices in inventory; 3) review your records and report the number, if any, of Hulka Clips from lot 51000232 that were implanted in your patients on the Recall Response Form; 4) complete and return the Recall Response Form attached to the letter; and, 5) a RMA number will be provided to customers returning the recalled products and those customers will receive a credit. All returned product should be sent to the attention of Ms. Lisa Williams, Regulatory Specialist. Customers with questions can contact Richard Wolf Medical Instruments at 800-323-9653 x 225 or 380.

    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)