Events

Recall of Fusion Pushing Catheter

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-2017-RN-00852-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2017-07-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00852-1
  • 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 identified a labelling issue with the fusion pushing catheter. the graphic on the product label on the fs-pc-7 device shows the outer diameter (od) of the pushing catheter is 7fr. however, the od of the pushing catheter for the fs-pc-7 device is 6fr; therefore the od has been incorrectly represented on the label. this issue impacts the product label only.The device has always been manufactured to the correct specification (6fr) and has been shown in design verification and validation during simulated use testing that it can be effectively used with a 7fr stent (as indicated on the label that it can be used with a 7fr stent).To date, there have been no complaints or reports of injury/illness due to this issue.
  • Action
    Cook Medical is requesting customers: 1. Examine inventory immediately to identify and quarantine affected products; 2. Return the required Acknowledgement and Receipt Form indicating quantities, part numbers, and lot numbers of affected products within 30 days; 3. Return any affected products as per the instructions in the acknowledgement and receipt Form; 4. Even if you do not have affected products, you must still complete the Acknowledgement and Receipt Form and send it via fax (07 3841 3905) or email to cau.custserv@cookmedical.com 5. Report adverse events to Cook Medical Customer Relations at cau.custserv@cookmedical.com , or call toll free -1800 777 222 Monday through Friday between 7:30 am and 5:00 pm (Eastern Time), or by email to: cau.custserv@cookmedical.com.

Device

Fusion Pushing Catheter

Manufacturer

William A Cook Australia Pty Ltd