Events

Recall of Device Recall Coolief Sinergy Cooled Radiofrequency Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Halyard Health, Inc.

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
    74553
  • Event Risk Class
    Class 2
  • Event Number
    Z-2391-2016
  • Event Initiated Date
    2016-06-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-09-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147894
  • 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
    Probe, radiofrequency lesion - Product Code GXI
  • Reason
    Mismatch between the length of the rf electrode (probe) and the cannula (introducer),.
  • Action
    All distributors and healthcare facilities that were directly shipped recalled devices were notified of the recall beginning 6/16/2016 by email and by FedEx. They were instructed to examine their stock and to quarantine and discontinue use of the product. The letter contained a response form which was to faxed back to Halyard.

Device

Device Recall Coolief Sinergy Cooled Radiofrequency Kit
  • Model / Serial
    Lot Number M5264D205
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of CT, IL, MA, MI, NV, NH, NC, and TX, and the country of Canada.
  • Product Description
    Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conjunction with a Radiofrequency Generator to create radiofrequency lesions in nervous tissue.
  • Manufacturer
    Halyard Health, Inc

Manufacturer

Halyard Health, Inc
  • Manufacturer Address
    Halyard Health, Inc, 5405 Windward Pkwy, Alpharetta GA 30004-3894
  • Source
    USFDA