Events

Recall of TDL6000MC Disposable Diathermy - Spatula tip with handle (Electrosurgical electrode)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Life Healthcare Pty Ltd.

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
    RC-2013-RN-01073-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-10-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01073-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    The recall is due to the two pieces of insulation on the handle not overlapping sufficiently, allowing the diathermy pen to spark through the insulation join when used with high voltage.This recall action was carried out prior to approval of the recall communication by the tga.
  • Action
    Life Healthcare has removed the affected stock from the customers. The manufacturer has redesigned the insulation to a one piece construction to remove the failure mode.

Device

TDL6000MC Disposable Diathermy - Spatula tip with handle (Electrosurgical electrode)
  • Model / Serial
    TDL6000MC Disposable Diathermy - Spatula tip with handle (Electrosurgical electrode)Lot Number: 1219857ARTG Number: 198434
  • Manufacturer
    Life Healthcare Pty Ltd

Manufacturer

Life Healthcare Pty Ltd