Events

Recall of Diego Elite Tubesets

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Olympus 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-2015-RN-00397-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-05-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00397-1
  • 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 reason for the recall is due to a possible breach of the package’s sterile barrier, therefore compromising the sterility of the product. the breach may not be easily seen. it is important to note that there are no concerns regarding the diego elite product performance. however, as a result there has been a temporary disruption in the supply of diego elite tube sets.
  • Action
    End users are requested to cease use of any affected product and quarantine it until it is shipped back to Olympus Australia Pty Ltd. This action has been closed-out on 08/08/2016.

Device

Diego Elite Tubesets
  • Model / Serial
    Diego Elite TubesetsItem Codes:TS100S – Diego Elite Tubeset, StandardTS101DC – Diego Elite Tubeset, DeclogARTG Number: 143268
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd