Events

Recall of Roth Net Standard Polyp Retriever U-711151

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-00072-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2017-01-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00072-1
  • 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
    It has been identified that the expiration date is incorrect on the outer packing label for several lots of the roth net device. the printed expiration date is earlier than the actual expiration date. please note that all individual roth net devices inner labels reference the correct expiration date. there is no impact on the performance of the product.
  • Action
    Device Technologies is advising users to quarantine affected products prior to returning them for replacement stock. This action has been closed-out on 05/07/2017.

Device

Roth Net Standard Polyp Retriever U-711151
  • Model / Serial
    Roth Net Standard Polyp Retriever U-711151 Lot Numbers: 1613898, 1616337, 1616733, 1616734 and 1616735 ARTG Number: 168702
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd