Events

Recall of Device Recall Electrode kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Valleylab, 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
    26842
  • Event Risk Class
    Class 2
  • Event Number
    Z-1122-03
  • Event Initiated Date
    2003-07-16
  • Event Date Posted
    2003-08-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-02-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28576
  • 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
    Apparatus, Electrosurgical - Product Code HAM
  • Reason
    Pads may have a thin plastic film covering the conductive gel surface underneath the normal printed cover, causing non-adherence and possible burn.
  • Action
    Users were notified by letter on 7/16/2003.

Device

Device Recall Electrode kit
  • Model / Serial
    Catalog Numbers: CT-1020, CT-1030, CT-1510, CT-1520, CT-1530, CT-2020, CT-2030, CT-2530, CTC-1025, CTC-1525, CTC-2025.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide. VA Hospital, San Antonio, TX. Foreign distribution to Australia, Brazil, Canada, Dominican Republic, France, Germany, Hong Kong, India, Israel, Japan, Korea, Phillipines, Singapore, Taiwan.
  • Product Description
    Radionics Cool-Tip RF Electrode Kit, containing DGP-HP single-use grounding pads.
  • Manufacturer
    Valleylab, Inc

Manufacturer

Valleylab, Inc
  • Manufacturer Address
    Valleylab, Inc, 5920 Longbow Drive, Boulder CO 80301
  • Source
    USFDA