Events

Recall of Codan Extension Set with T Connector

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by REM Systems 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-00821-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-06-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00821-1
  • 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 codan usa corporation has received isolated reports of extension sets leaking during use. the manufacturer has advised that production of the me-bc2005 has now ceased and that any stock remaining with customers should be recalled as they are potentially non-conforming.
  • Action
    REM Systems is requesting that customers: 1. Review their inventory and quarantine all stock of the ME-BC2005 Extension sets and await replacement with an equivalent alternate set at no extra charge; and 2. Advise other relevant staff within the organisation of this issue; and 3. Complete and return the acknowledgment form supplied by REM Systems

Device

Codan Extension Set with T Connector
  • Model / Serial
    Codan Extension Set with T ConnectorCatalogue Number: ME-BC2005All Batch NumbersARTG Number: 126685
  • Manufacturer
    REM Systems Pty Ltd

Manufacturer

REM Systems Pty Ltd