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-00770-1
  • Event Risk Class
    Class III
  • 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-00770-1
  • 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
    Bard medical division (bmd) has confirmed that lot ngar0462 is incorrectly identified as 317-09 (large kit) rather than 317-07 (medium kit) on the product (shelf) box. specifically, the shelf box has a black tick mark in the catalogue marked 317-09 instead of 317-07. the shelf box label with barcode and the pouch label is correctly identified as 317-07 and lot number ngar0462. this mislabelling could potentially result in a slight delay in therapy but is not associated with long term or residual clinical consequences.
  • Action
    Bard Australia is requesting that following an inspection of stock on hand, customers should cross out the incorrectly marked line and tick the correct box “317-07”. The Recall for Product Correction does not require affected stock to be returned. Affected stock can remain on your shelves.

Device

Bard ArcticSun ArticGel Pads
  • Model / Serial
    Bard ArcticSun ArticGel PadsProduct Code: 317-07Lot Number: NGAR0462 ARTG Number: 262560
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd