Events

Recall of Kii abdominal trocars

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Applied Medical 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-00636-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-05-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00636-1
  • 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
    Applied medical has identified the possibility that specific models and lots of kii abdominal trocars have insufficient sterilisation.
  • Action
    Users are requested to return any affected product with a copy of the Recall Notification Confirmation Form to Applied Medical as per the instructions in the Customer Letter.

Device

Kii abdominal trocars
  • Model / Serial
    Kii abdominal trocars5x55mm Kii Shielded Bladed Z-Thread Dual PackModel Number: CTB14 Lot Numbers: 1288910, 1275207, 1279542 and 1283892 5x55mm Kii Low Profile Bladed Z-Thread Dual PackModel Number: CTB23 Lot Numbers: 1281263, 1269692, 1288759 and 1271037ARTG Number: 224148
  • Manufacturer
    Applied Medical Australia Pty Ltd

Manufacturer

Applied Medical Australia Pty Ltd