Events

Recall of Bard ArcticSun ArticGel Pads

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Bard 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-01405-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-11-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01405-1
  • 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, bard medical division (bmd), has identified specific lots of bard arcticsun articgel pads that have insufficient adhesion of the hydrogel to the pad, which has the risk of the hydrogel peeling away from pads during the removal of the release liner.
  • Action
    Bard is providing customers with additional instructions for use to identify the potential issue, and provide guidance to allow the product to be used in a normal manner.

Device

Bard ArcticSun ArticGel Pads
  • Model / Serial
    Bard ArcticSun ArticGel PadsItem Code: 31700Lot/Serial Numbers: NGAW3898 and NGBP1302Item Code: 31705Lot/Serial Numbers: NGAZ2312 and NGBN2492Item Code: 31707Lot/Serial Numbers: NGBN3536ARTG Number: 262560 (Heating unit, pad, water)
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd