Events

Recall of Kii Abdominal Troacar5x55mm Kii Optical Z-Thread Dual Pack

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-01102-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-08-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01102-1
  • 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 been advised that during shipment, the packaging of specific lots of kii abdominal troacars have the potential to become punctured with small holes, which would compromise the sterile barrier.
  • Action
    1. Users are to complete the Customer Recall Notification Confirmation Form supplied with the customer letter to acknowledge the recall and indicate if they are returning or have already used the affected lots. 2. If no product is being returned, indicate this on the supplied Customer Recall Notification Confirmation Form 3. Return the supplied Recall Notification Confirmation Form to Applied Medical Australia 4. Return affected product and a copy of the supplied Recall Notification Confirmation Form to Applied Medical.

Device

Kii Abdominal Troacar5x55mm Kii Optical Z-Thread Dual Pack
  • Model / Serial
    Kii Abdominal Troacar5x55mm Kii Optical Z-Thread Dual PackModel Number: CTR14Lot Numbers: 1269694, 1275188, 1279039, 1283226, and 1287785ARTG Number: 224148
  • Manufacturer
    Applied Medical Australia Pty Ltd

Manufacturer

Applied Medical Australia Pty Ltd