Events

Recall of Corometrics Qwik Connect Plus Spiral Electrode

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Vital Signs Devices, a GE Healthcare Company.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    63481
  • Event Risk Class
    Class 2
  • Event Number
    Z-0330-2013
  • Event Initiated Date
    2012-10-16
  • Event Date Posted
    2012-11-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113969
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Electrode, circular (spiral), scalp and applicator - Product Code HGP
  • 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.

Device

Corometrics Qwik Connect Plus Spiral Electrode
  • Model / Serial
    Lot #S03123 Model #7000AA0
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product 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.
  • Manufacturer
    Vital Signs Devices, a GE Healthcare Company

Manufacturer

Vital Signs Devices, a GE Healthcare Company
  • Manufacturer Address
    Vital Signs Devices, a GE Healthcare Company, 20 Campus Rd, Totowa NJ 07512-1210
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA