Events

Recall of Cook Beacon Tip Angiography Catheters Beacon Tip Torcon NB Advantage Catheters, Beacon Tip Royal Flush Plus High-Flow Catheters, Beacon Tip Catheters,Shuttle Select Slip-Cath, 4 FR Shuttle System Compatible

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-01012-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-10-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01012-1
  • 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 all lots in distribution 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
    Cook Medical is advising users to inspect and quarantine any affected lots for return 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 CathetersCatalogue Prefix: HNBR4.0, HNBR4.1 and only HNBR5.0 w/RUC SuffixBeacon Tip Royal Flush Plus High-Flow CathetersCatalogue Prefix: HNR4.0Slip-Cath Beacon Tip CathetersCatalogue Prefix: SCBR4.0, SCBR4.1, and only SCBR5.0 w/RUC SuffixShuttle Select Slip-Cath, 4 FR Shuttle System CompatibleCatalogue Prefix: SCBR4.5Multiple Lot Numbers affectedARTG Numbers: 137861, 154909, 154911, 137865
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd