Events

Recall of Bard Max-Core Disposable Core Biopsy Instrument

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-2015-RN-00330-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-04-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00330-1
  • 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 peripheral vascular (bpv) has identified potential self-activation issues with the instrument during use that may pose an incremental increase in the risk associated with biopsy procedures. this includes prolonging the procedure, requiring the use of an additional device, or minor tissue injury to the patient if the device fails to fire. potential self-activation, may potentially lead to inadvertent injury to deep tissue or structures, blood vessels or adjacent critical organs. in addition, a used device may pose an incremental risk of blood borne contamination to the user if self-activated. in the event this occurred, the patient or user may require urgent medical or surgical intervention and the user is to follow facility procedures for inadvertent needle sticks or injury.
  • Action
    Bard Australia is requesting the customers to quarantine and stop using the affected product. Bard Australia is arranging for any affected product to be returned and replaced. This action has been closed-out on 1/06/2016.

Device

Bard Max-Core Disposable Core Biopsy Instrument
  • Model / Serial
    Bard Max-Core Disposable Core Biopsy Instrument Product Code: MC 1820Lot Numbers: REYA2017 & REYC2853ARTG number: 180984
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd