BEUDAMED
    FDA Recall 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 · Initiated October 16, 2012

    Recall

    Recall Number
    Z-0330-2013
    Event Number
    63481
    Firm
    Vital Signs Devices, a GE Healthcare Company
    FEI Number
    2242551
    Product Code
    HGP
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    October 16, 2012
    Posted
    November 16, 2012
    Terminated
    April 16, 2014
    Address
    20 Campus Rd, Totowa, NJ, 07512-1210

    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.

    Action

    The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter on October 16, 2012 via Fed Ex to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: DO NOT use Qwik Connect Plus Spiral Electrodes part number 7000AAO with lot number S03123 or product with missing lot numbers; isolate all affected product; complete and return the Urgent Medical Device Correction Confirmation form via fax at 800-535-7923, return form even if no recall product is in inventory; to return only unused product, and if they have forwarded any affected lot numbers of this product to any other healthcare institutions, forward a copy of this letter to those institutions. If you have any questions or concerns regarding this notification, contact GEMSIT Customer Service at +1-800-588-7044 (Domestic) or Vital Signs Customer Service at +1-800-932-0760 (International). Hours of operation: 8:00 am EST to 6:00 pm EST.

    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)