BEUDAMED
    FDA Recall Terminated

    PADPRO ADULT Radiotranslucent Pad w/Medtronic connector, REF/Catalog #2516M. RX ONLY. Defibrillation/Pacing/Cardioversion/Monitoring Electrodes. Made in USA for: CONMED CORPORATION Utica, New York, 13502.

    Recall: Z-0757-2007 · Initiated March 8, 2007

    Recall

    Recall Number
    Z-0757-2007
    Event Number
    37495
    Firm
    Conmed Corporation
    FEI Number
    3001451571
    Product Code
    MLN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 8, 2007
    Posted
    April 24, 2007
    Terminated
    July 16, 2012
    Address
    525 French Road, Utica, NY, 13502-5945

    Description

    PADPRO ADULT Radiotranslucent Pad w/Medtronic connector, REF/Catalog #2516M. RX ONLY. Defibrillation/Pacing/Cardioversion/Monitoring Electrodes. Made in USA for: CONMED CORPORATION Utica, New York, 13502.

    Reason

    Firm was notified of three incidents over the past 15 months in which customers opened the pouch & found an incorrect connector. This error makes the product unusable. The Zoll and Medtronic connectors are not interchangeable and are unique to their specific device.

    Action

    On 3/08/07, "URGENT DEVICE RECALL" letters (dated 3/05/07) will be sent via UPS to the US distributors and direct user accounts. The letters inform them of the problem and of the recall. The letters instruct them to immediately discontinue using the affected lots, inspect their stocks, and to return them as soon as possible. The letters instruct the consignees to notify their customers of the recall of the devices to the user level if they have been distributed, and request the return of the products. Additionally, when requested, ConMed will notify distributor's customers (sub-accounts) by the same means. Returned devices will be automatically replaced by ConMed Corporation. A separate letter is being sent to the foreign accounts today instructing them to return the devices back to ConMed Corporation for final disposition. The letters also instruct the consignees to complete the accompanying reply form and fax it to Nancy Crisino at (315) 624-3089. ConMed has contracted Stericycle in Indianapolis, IN, to handle the recall and returns from the domestic accounts.

    Distribution

    Worldwide, including USA, Canada, Romania, Chile, and Belgium

    Quantity

    920 pairs