Events

Recall of Caliber Inflation Device

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-00758-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-06-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00758-1
  • 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, perouse medical has identified that specific product code / lot number combinations of the caliber inflation device may be at risk of containing a crack in the primary packaging, resulting in a breach of the sterile barrier. for a cracked package, there is the risk of microbial contamination (infection) caused by the use of a product. sterility would not be preserved due to a primary packaging damage.
  • Action
    Bard is advising users to immediately examine their inventory, and quarantine and remove product subject to this recall from their shelves. Do not use or further distribute any affected product. Product is to be returned by either handing to the user's Bard Territory Manager or by contacting Bard Australia Customer Service who will arrange for the return of any affected product.

Device

Caliber Inflation Device
  • Model / Serial
    Caliber Inflation DeviceProduct Code: CL3030Lot Numbers: 15045606, 15055430, 15065858, 15075121, 15075411, 15075821 and 15085378ARTG Number: 174371
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd