Events

Recall of ARCTICGEL Pads (used with the Arctic Sun Temperature Management System)

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-2016-RN-00234-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-03-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00234-1
  • 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 received complaint reports of low flows associated with certain lots of the arcticgel pads. the clinical risk associated with the restricted/low flow arcticgel pads is suboptimal therapy delivery. in the event that one or more arcticgel pads do not have sufficient flow, the arcticgel pads may need to be exchanged. this may result in a slight delay in the therapy delivery which, if done in a timely manner, is not associated with long-term or residual clinical consequences. if alternate pads are not available, the patient may require therapy delivery by alternate means.
  • Action
    Bard is advising users to inspect stock for the affected lot numbers. Any remaining affected product can be returned. This action has been closed-out on 30/01/2017.

Device

ARCTICGEL Pads (used with the Arctic Sun Temperature Management System)
  • Model / Serial
    ARCTICGEL Pads (used with the Arctic Sun Temperature Management System)Multiple Product Codes and Lot Numbers affectedARTG Number: 262560
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd