Events

Recall of The ARROWg+ard Blue PLUS antimicrobial catheter

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Teleflex 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-2018-RN-00358-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-04-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00358-1
  • 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
    It has been identified that certain product may have packaging that is not sealed. in the event the packaging is compromised in this manner, sterility of the product cannot be guaranteed. if a non-sterile product is used, there is potential for an infection to occur. to date, teleflex medical has not received reports of this issue in australia.
  • Action
    Teleflex is advising customers to inspect inventory for impacted lots and identify any units that appear to be affected. These units should then be discarded and Teleflex will provide a suitable credit following receipt of the acknowledgement form suppled with the customer letter.

Device

The ARROWg+ard Blue PLUS antimicrobial catheter
  • Model / Serial
    The ARROWg+ard Blue PLUS antimicrobial catheterMultiple Lot NumbersARTG Numbers: 138302, 136923, 278735, 278926 and 279697
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd