Events

Recall of Bard EnCor Needle Guide Insert (part of the EnCor Breast Biopsy Probe)

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-01101-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-08-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01101-1
  • 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 has identified that the affected lot numbers may be at risk of having an incorrect encor accessory needle guide insert. specifically, a smaller diameter (12g) insert may be contained within the larger (10g) package. this will render the device unusable and the user will need to replace the incorrect needle guide with one of the correct size. to date, bard have received 6 complaints from customers that have received the smaller product in error; none have resulted in an adverse event to patient or loss of functionality of the encor probe.
  • Action
    Bard is advising users that if the incorrect Needle Guide Insert is contained within the packaging, to utilise a new biopsy probe (12G) for the procedure. This action has been closed-out on 10/05/2017.

Device

Bard EnCor Needle Guide Insert (part of the EnCor Breast Biopsy Probe)
  • Model / Serial
    Bard EnCor Needle Guide Insert (part of the EnCor Breast Biopsy Probe)Item Code: ENCFINSERT10GMultiple Lot numbers affectedARTG Number: 153519
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd