Events

Recall of 1680 Invisatrace series ECG Electrodes, radiotranslucent clear tape ECG electrode with wet gel. This is a single use, disposable device. Electrodes are packaged and sold as: Cat No 1680-001 (1 unit per pouch/30 per box); Cat No 1680-003 (3 units per pouch/30 per box); Cat No 1680-005 (5 units per pouch/50 per box); and Cat No 1680-030 (30 units per pouch/no box). The electrodes are packaged 600 units/case. || Responsible firm on the label: Conmed Corp., 310 Broad St., Utica, New York

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

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
    26988
  • Event Risk Class
    Class 2
  • Event Number
    Z-1184-03
  • Event Initiated Date
    2003-07-30
  • Event Date Posted
    2003-08-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-03-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28950
  • 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, Electrocardiograph - Product Code DRX
  • Reason
    Separation of the sensing element from the body of the electrode.
  • Action
    Letters dated 7/30/03 requesting return of recalled lots and subrecall by distributors.

Device

1680 Invisatrace series ECG Electrodes, radiotranslucent clear tape ECG electrode with wet gel. ...
  • Model / Serial
    Cat No. 1680-001: 0305301, 0306091, 0306092. Cat No. 1680-003: 0306241. Cat No. 1680-005: 0306042. Cat No. 1680-030: 0306021, 0306051.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    241 direct accounts including wholesalers and medical facilities. Of these, there are 15 foreign consignees in Canada, Belgium, Germany, Norway, The Netherlands, Spain, United Kingdom, Japan, Malaysia, Thailand, and United Arab Emirates .
  • Product Description
    1680 Invisatrace series ECG Electrodes, radiotranslucent clear tape ECG electrode with wet gel. This is a single use, disposable device. Electrodes are packaged and sold as: Cat No 1680-001 (1 unit per pouch/30 per box); Cat No 1680-003 (3 units per pouch/30 per box); Cat No 1680-005 (5 units per pouch/50 per box); and Cat No 1680-030 (30 units per pouch/no box). The electrodes are packaged 600 units/case. || Responsible firm on the label: Conmed Corp., 310 Broad St., Utica, New York
  • Manufacturer
    Conmed Corporation

Manufacturer

Conmed Corporation
  • Manufacturer Address
    Conmed Corporation, 525 French Road, Utica NY 13502
  • Source
    USFDA