BEUDAMED
    FDA Recall Terminated

    R2 Adult R2 Non-Radiolucent Multifunction Electrodes, Catalog/REF No. 3200-1715, NON-STERILE, MADE IN USA, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13507 This device, when connected to a monitor/defibrillator has the ability to monitor the electro-cardio function (ECG) of the patient. The device, when electrically activated by the monitor/defibrillator can pace the heart rate of the patient and may also transmit the electrical current to the patient for cardio-conversion. This is a non-sterile, disposable device.

    Recall: Z-0856-2012 · Initiated March 31, 2011

    Recall

    Recall Number
    Z-0856-2012
    Event Number
    60701
    Firm
    ConMed Corporation
    FEI Number
    3001451571
    Product Code
    MLN
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    March 31, 2011
    Posted
    January 25, 2012
    Terminated
    January 26, 2012
    Address
    525 French Road, Utica, NY, 13502

    Description

    R2 Adult R2 Non-Radiolucent Multifunction Electrodes, Catalog/REF No. 3200-1715, NON-STERILE, MADE IN USA, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13507 This device, when connected to a monitor/defibrillator has the ability to monitor the electro-cardio function (ECG) of the patient. The device, when electrically activated by the monitor/defibrillator can pace the heart rate of the patient and may also transmit the electrical current to the patient for cardio-conversion. This is a non-sterile, disposable device.

    Reason

    The specific lot was assembled without the rivet cover.

    Action

    ConMed Corporation sent a Urgent Medical Device Recall Letter dated March 25, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to immediately stop use of the device and return it to ConMed Corporation. Please review your inventory for any of the devices listed on Attachment I. If you do not have any devices to return, please follow the instructions in the letter and complete Attachment II, indicating you have no devices and fax it to 315-624-3225. Please complete the attached Business reply form. We apologize for any inconvenience this will cause you or your staff. For further questions please call (315) 797-8375.

    Distribution

    Worldwide Distribution -- USA (nationwide) and the countries of Canada, Belgium, Germany and Hong Kong.

    Quantity

    850 sets (2 pads per set in individual pouch)