BEUDAMED
    FDA Enforcement Class II Terminated

    Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 A fetal scalp circular (spiral) electrode and applicator is a device used to obtain a fetal electrocardiogram during labor and delivery.

    Recall: Z-0330-2013 · Reported November 28, 2012

    Enforcement

    Recall Number
    Z-0330-2013
    Event ID
    63481
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Vital Signs Devices, a GE Healthcare Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 28, 2012
    Initiation Date
    October 16, 2012
    Classification Date
    November 16, 2012
    Termination Date
    April 16, 2014
    Address
    20 Campus Rd, N/A, Totowa, NJ, 07512-1210, United States

    Description

    Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 A fetal scalp circular (spiral) electrode and applicator is a device used to obtain a fetal electrocardiogram during labor and delivery.

    Reason

    Thirty fetal scalp electrodes were found to have an incomplete package seal and lacked the printed lot number stamped on during sealing.

    Code Info

    Lot #S03123 Model #7000AA0

    Distribution

    Worldwide distribution: USA (nationwide) including states: AZ, CA, CT, FL, GA, IL, KS, KY, MA, MD, MN, MO, NJ, NM, NY, OH, PA, SC,TX, WA, and WY; and countries of: Australia and Canada.

    Quantity

    126 cases (50 pouches per case)