Events

Recall of ADT1018 and ADT1018-50 Flow QC Tubing – haemodialysis blood tubing Set

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

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-2018-RN-00220-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2018-03-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00220-1
  • 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
    Emergo has been notified by the manufacturer, transonic systems (transonic), that the sterility of adt1018 flow qc tubing set cannot be assured. transonic is not aware of any actual products that are not sterilized; however, there is a small risk that unsterilized product may have been released. given this possibility, in the event the adt1018 flow qc tubing were to be used without being sterilized, this would increase the risk of infection post use for patients who have come into contact with any unsterilized product. to date, no complaints or adverse events have been reported to transonic related to this issue.
  • Action
    Transonic has discontinued the ADT1018 product line and has ceased purchasing product from this supplier entirely. The ADT1010 tubing set replaces ADT1018 Flow QC tubing. Emergo is advising users to immediately discontinue use and distribution of the affected product. Return or destroy the affected product and document that destruction on the Medical Device Recall Return Response Form provided with the Customer Letter. Upon receipt of the completed form a product replacement will be issued. If it appears that any patients have had contact with the ADT1018 Flow QC tubing set, please observe these patients for any signs of infection as per your hospital protocol and report if any such events take place.

Device

ADT1018 and ADT1018-50 Flow QC Tubing – haemodialysis blood tubing Set
  • Model / Serial
    ADT1018 and ADT1018-50 Flow QC Tubing – haemodialysis blood tubing Set Catalogue Number: ADT1018Lot Numbers: B151130E2 and B161115E0Expiry: 30/11/2018 and 15/11/2019Catalogue Number: ADT1018-40Lot Numbers: B151130E2 and B161115E0Expiry: 30/11/2018 and 15/11/2019ARTG Number 187558
  • Product Classification
    Gastroenterology-Urology Devices
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia