Events

Recall of Zenith Branch Iliac Endovascular Graft (ZBIS) - Patient Card

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by William A Cook 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-2018-RN-00118-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2018-02-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00118-1
  • 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
    Cook medical has become aware that an incorrect patient card may have been included in the zenith branch endovascular graft - iliac bifurcation (zbis) devices supplied between november 2017 and january 2018. the device name on the incorrect patient card is zenith p-branch and the mri image artefact radius specified on the zbis patient card is slightly different from the image artefact radius on the incorrect patient card. the patient card is the only portion of the product impacted, there is no impact on the packaged device.There have been no customer complaints received to date in regards to this issue.
  • Action
    Cook Medical is providing replacement patient cards to all affected customers.

Device

Zenith Branch Iliac Endovascular Graft (ZBIS) - Patient Card
  • Model / Serial
    Zenith Branch Iliac Endovascular Graft (ZBIS) - Patient CardReference Part Numbers: ZBIS-12-61-41, ZBIS-12-45-41, ZBIS-12-45-58, ZBIS-12-61-58, ZBIS-10-61-58, ZBIS-10-45-41, ZBIS-10-61-41Multiple lot numbers affectedARTG Number: 138930
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd