BEUDAMED
    FDA Recall Terminated

    R2 Adult Zoll Non-Radiolucent Multifunction Electrodes, Catalog/REF 3111-1721, NON-STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13505. 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-0735-2012 · Initiated March 9, 2011

    Recall

    Recall Number
    Z-0735-2012
    Event Number
    60700
    Firm
    ConMed Corporation
    FEI Number
    3001451571
    Product Code
    LDD
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    March 9, 2011
    Posted
    January 12, 2012
    Terminated
    January 12, 2012
    Address
    525 French Road, Utica, NY, 13502

    Description

    R2 Adult Zoll Non-Radiolucent Multifunction Electrodes, Catalog/REF 3111-1721, NON-STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13505. 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 product lot was assembled with an R2 Connector, rather than a Zoll Connector.

    Action

    ConMed Corporation sent an "URGENT: DEVICE RECALL" letter dated March 9, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to review their inventory for the affected product and to stop use of the devices immediately. A Business Reply Form was attached for customers to complete and return to the firm via fax to 315-624-3225. Additionally, instructions were provided on how to return the affected devices. Contact the ConMed Recall Coordinator at 315-624-3237 for questions regarding this notice.

    Distribution

    Nationwide Distribution-including the states of AZ, CA, IN, and MI.

    Quantity

    190 sets (2 pads per set in individual pouch)