Events

Recall of Laparascopic inserts with tube, 3.00mm

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Life Healthcare 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-01307-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-12-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01307-1
  • 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 manufacturer has identified a potential risk with the affected laparascopic inserts where during reprocessing, the inner lumen of these laparascopic inserts cannot be flushed out sufficiently with the recommended rising tip. further investigation showed that all inserts, which cannot be disassembled are affected, and that this it could lead to infection.
  • Action
    The affected laparoscopic instruments have not been used and are in their original packaging. Life Healthcare is advising users to return the affected laparoscopic instruments for replacement stock .

Device

Laparascopic inserts with tube, 3.00mm
  • Model / Serial
    Laparascopic inserts with tube, 3.00mmItem Numbers: RS-003-316, RS-003-325, RS-003-390Lot Numbers: 13J028#06102952, 13J028#06082301, 06082129/28,08ARTG Number: 141681
  • Manufacturer
    Life Healthcare Pty Ltd

Manufacturer

Life Healthcare Pty Ltd