BEUDAMED
    FDA Recall Terminated

    Box Label: 3 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-3KDINX . Pouch labels: Each kit contains 3 pouches. 3 mm Cueva Electrode CNE-3X, Cueva Electrode Applicator Wand CNE-100X, Cueva Electrode Leadwire CNE-LW-2DINX. Box Label: 2 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-2KDINX . Pouch labels: Each kit contains 3 pouches. 3 mm Cueva Electrode CNE-2X, Cueva Electrode Applicator Wand CNE-100X, Cueva Electrode Leadwire CNE-LW-2DINX.

    Recall: Z-0106-2015 · Initiated October 8, 2014

    Recall

    Recall Number
    Z-0106-2015
    Event Number
    69436
    Firm
    Ad-Tech Medical Instrument Corporation
    FEI Number
    2183456
    Product Code
    GZL
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 8, 2014
    Posted
    October 21, 2014
    Terminated
    April 8, 2015
    Address
    1901 William St, Racine, WI, 53404-1876

    Description

    Box Label: 3 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-3KDINX . Pouch labels: Each kit contains 3 pouches. 3 mm Cueva Electrode CNE-3X, Cueva Electrode Applicator Wand CNE-100X, Cueva Electrode Leadwire CNE-LW-2DINX. Box Label: 2 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-2KDINX . Pouch labels: Each kit contains 3 pouches. 3 mm Cueva Electrode CNE-2X, Cueva Electrode Applicator Wand CNE-100X, Cueva Electrode Leadwire CNE-LW-2DINX.

    Reason

    The recall has been initiated due to concerns that the applicator wand may malfunction potentially causing the inability to monitor the VII cranial nerve. .

    Action

    Consignees were sent on 10/8/2014 an AD-TECH "Medical Device Recall" letter dated October 6, 2014. The letter described the Reason for the Voluntary Recall, Risk to Health, Action to be taken by the Customer, Product and Distribution Information and Other Information. Requested consignees to return the "Acknowledgement and Receipt Form" to their Ad-Tech Clinical Specialists Fax 262-634-5668, Telephone 262-634-1555, [email protected]. For additional information they can use the same number.

    Distribution

    Worldwide Distribution: US (nationwide) in the states of: CO, FL, LA, NJ, OH, WA, and WI; and internationally to: Finland.

    Quantity

    13 kits (26 electrodes, 26 applicator wands, 26 leadwires).