Events

Recall of Inzii 12/15mm Retrieval System (used as a receptacle for the collection and extraction of tissues, organs and calculi during laparoscopic procedures)

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-2013-RN-01090-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-10-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01090-1
  • 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
    During shipment, the retrieval system packaging has the potential to become punctured with small holes, which could compromise the sterile barrier.
  • Action
    Applied Medical is advising users to return affected stock for replacement with unaffected stock.

Device

Inzii 12/15mm Retrieval System (used as a receptacle for the collection and extraction of tissues...
  • Model / Serial
    Inzii 12/15mm Retrieval System (used as a receptacle for the collection and extraction of tissues, organs and calculi during laparoscopic procedures)Model Number: CD004Multiple lot numbers affectedManufactured from 20 January 2012 to 21 August 2013ARTG Number: 139393
  • Manufacturer
    Applied Medical Australia Pty Ltd

Manufacturer

Applied Medical Australia Pty Ltd