Events

Recall of STF Load Check Indicators (ultrasonic bath efficacy indicator)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Device Technologies Australia 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-00416-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-05-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00416-1
  • 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
    Lot 022473 was manufactured in june 2012 and is incorrectly labelled an expiry date of june 2013; the correct expiry date is may 2013, indicating that the product can be used through 31 may 2013.
  • Action
    Customers are requested to inspect their stock and isolate any product from lot 022473. All affected stock is required to be destroyed prior to 31 May 2013. Replacement units will be provided by Device Technologies.

Device

STF Load Check Indicators (ultrasonic bath efficacy indicator)

Manufacturer

Device Technologies Australia Pty Ltd