Events

Recall of Selector Tubing Kit for use with CUSA Selector Ultrasonic Aspirators

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Integra Neurosciences 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-2014-RN-01079-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-10-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01079-1
  • 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
    Integra neurosciences has identified through an investigation of complaints that some specific lots of selector® tubing kits may potentially leak irrigation fluid during use if not placed on the selector handpiece in a specific manner. if the lumens of the 2 tubes are not separated before placing them on the handpiece barbs, this could result in an irrigation fluid leak. if the leakage is significant, the handpiece tip could overheat and possibly burn tissue being treated.
  • Action
    Integra is providing additional instructions to prevent the occurrence of leakage. This action has been closed-out on 03/06/2016.

Device

Selector Tubing Kit for use with CUSA Selector Ultrasonic Aspirators
  • Model / Serial
    Selector Tubing Kit for use with CUSA Selector Ultrasonic Aspirators Catalogue number: 1517079Multiple lot numbersARTG number: 146847
  • Manufacturer
    Integra Neurosciences Pty Ltd

Manufacturer

Integra Neurosciences Pty Ltd