Events

Recall of V-PRO 60 Low Temperature Sterilisation System with VAPROX HC Sterilant Distributed between 31 July 2014 and 17 August 2017

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-2017-RN-01395-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-11-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01395-1
  • 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
    Device technologies has identified a software issue where the v-pro 60 software verifies expiration date of the vaprox sterilant upon completion of the sterilisation cycle rather than prior to cycle initiation. verification of the vaprox expiration date at the end of the sterilisation cycle will allow for the completion of one cycle with expired vaprox sterilant. to date, the manufacturer steris has not received any reports of adverse events related to this issue.
  • Action
    Device Technologies is advising users that microbial efficacy studies support a safety margin for use of the product for three days after the indicated expiry date. Users are advised to ensure the cycle printout indicates the expiration date of the Sterilant upon the completion of each cycle and change the sterilant if required. Instruments processed in a cycle with sterilant more than three days beyond its expiry date are not considered properly sterilised and should be reprocessed with a new cup of sterilant before use. Device Technologies will be performing a software update as a permanent correction.

Device

V-PRO 60 Low Temperature Sterilisation System with VAPROX HC Sterilant Distributed between 31 Jul...
  • Model / Serial
    V-PRO 60 Low Temperature Sterilisation System with VAPROX HC SterilantDistributed between 31 July 2014 and 17 August 2017ARTG Number: 154905
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd