Events

Recall of SenoMark UltraCor MRI 14 Gauge Breast Tissue Markers (used for radiographic marking of breast biopsy sites)

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-01314-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-10-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01314-1
  • 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
    It has been identified that the product code / lot number combination for a single lot of the device may have an incorrect instruction for use (ifu) containing a table in the description section that misidentifies the wireform and material (titanium and stainless steel). all other product labelling, including outer box and inner packaging, correctly identify the product.The potential exists that a user might inadvertently use a senomark ultracor mri 14 gauge tissue marker of the wrong material in a patient with known hypersensitivity to titanium.
  • Action
    Bard is providing users with instructions for use that correctly identify the wireform and material. The product can be continued to be used. This action has been closed-out on 17/05/2017.

Device

SenoMark UltraCor MRI 14 Gauge Breast Tissue Markers (used for radiographic marking of breast bio...
  • Model / Serial
    SenoMark UltraCor MRI 14 Gauge Breast Tissue Markers (used for radiographic marking of breast biopsy sites)Product code: SMUCMRI14GTLot number: VT15M0543ARTG number: 160027
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd