BEUDAMED
    FDA Recall Terminated

    OLYMPUS Pediatric Knives and Resection Electrodes The pediatric knives are intended for use in urethrotomy in pediatric applications. The HF resection electrodes are intended for use in transurethral resection in pediatric applications.

    Recall: Z-3102-2011 · Initiated December 22, 2010

    Recall

    Recall Number
    Z-3102-2011
    Event Number
    57590
    Firm
    Olympus America Inc.
    FEI Number
    2429304
    Product Code
    EZO
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    December 22, 2010
    Posted
    August 31, 2011
    Terminated
    September 28, 2012
    Address
    3500 Corporate Pkwy. P.O. Box 610, Center Valley, PA, 18034-0610

    Description

    OLYMPUS Pediatric Knives and Resection Electrodes The pediatric knives are intended for use in urethrotomy in pediatric applications. The HF resection electrodes are intended for use in transurethral resection in pediatric applications.

    Reason

    The device sterile package seal shows evidence of being breached or was breached

    Action

    Olympus America Inc. sent an "URGENT PRODUCT RECALL" letter dated December 22, 2010 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to check their inventory for the affected product and to destroy or discard, if found. A questionnaire was attached to the letter for customers to complete and return via fax to Olympus at 484-896-7128. Contact the firm at 484-896-5688 for questions regarding this recall.

    Distribution

    USA (nationwide) including the states of AL, AR, CA, CO, CT, FL, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OR, TX, VA, VT, and WI.

    Quantity

    1305 devices