Events

Recall of ClaveGuard Diathermy Pencil

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by ClaveGuard 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-2016-RN-00280-2
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-03-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00280-2
  • 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
    Claveguard has been advised that diathermy pencils manufactured under batch number 181214sy have an issue with the quality of the ink used for the sterility check mark, which may compromise the ability to clearly discern the colour change. as a precautionary measure, claveguard is recalling the affected batch.
  • Action
    The sponsor ClaveGuard advises customers to discontinue use of any remaining stock of the affected batch prior to their quarantine. The sponsor will arrange for the replacement and recovery of the affected units. This action has been closed-out on 16/02/2017.

Device

ClaveGuard Diathermy Pencil
  • Model / Serial
    ClaveGuard Diathermy PencilBatch Number: 18214SYARTG Number: 222138
  • Manufacturer
    ClaveGuard Pty Ltd

Manufacturer

ClaveGuard Pty Ltd
  • Source
    DHTGA