Events

Recall of Cook Beacon Tip angiography catheters Beacon Tip Torcon NB Advantage Catheters, Beacon Tip Royal Flush Plus High-Flow Catheters, Slip-Cath Beacon Tip Catheters

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-2015-RN-00670-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-07-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00670-1
  • 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 is initiating a recall of the listed products following reports of catheter tip splits and/or separation. potential adverse events that may occur as a result of catheter tip splitting and or separation may include the loss of device function, medical intervention to retrieve the separated segment, or complications resulting from the separated tip occluding blood flow to end organs.
  • Action
    Customers are advised to quarantine any affected product that remains unused and return it to Cook Medical.

Device

Cook Beacon Tip angiography catheters Beacon Tip Torcon NB Advantage Catheters, Beacon Tip Royal...
  • Model / Serial
    Cook Beacon Tip angiography cathetersBeacon Tip Torcon NB Advantage Catheters Catalogue number: HNBR5.0Beacon Tip Royal Flush Plus High-Flow Catheters Catalogue number: HNR4.0Slip-Cath Beacon Tip CathetersCatalogue number: SCBR5.0Multiple lot numbersARTG Number: 137861
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd