Events

Safety Alert for Fusion Pushing Catheter

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Cook Medical.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2017-07-11
  • Event Date Posted
    2017-07-11
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170711a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: cook medical fusion pushing catheter medical device manufacturer, cook medical, has issued a medical device safety alert concerning its fusion pushing catheter. the recorder number of the affected product is fs-pc-7. the manufacturer is initiating a voluntary recall of the cook 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. according to the manufacturer, the device 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). in summary there is negligible/low risk associated with using the current device, and there are no immediate or long range health consequences as a result of this labeling error. the manufacturer advises users to examine inventory to determine if they have the affected products. if you are in possession of the affected products, please contact your supplier for necessary actions. according to the manufacturer, the affected products are distributed in hong kong. posted on 11 july 2017.

Device

Fusion Pushing Catheter
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Cook Medical Fusion Pushing Catheter
  • Manufacturer
    Cook Medical

Manufacturer

Cook Medical