Events

Safety Alert for Fire Star™ Rx PTCA Dilatation Catheter

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

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
    2012-06-12
  • Event Date Posted
    2012-06-12
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120612c.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: cordis fire star™ rx ptca dilatation catheter medical device manufacturer, cordis corporation, has issued a field safety notice concerning cordis fire star™ rx ptca dilatation catheter. the manufacturer is recalling lot 15437344 of cordis fire star™ rx ptca dilatation catheter (catalog number 8012020d) because it has identified that products of the affected lot has a potential to exhibit “slow deflation” or “no deflation”. according to the local supplier, johnson & johnson (hk) limited, the affected devices were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted 12 jun 2012.

Device

Fire Star™ Rx PTCA Dilatation Catheter
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Cordis Fire Star™ Rx PTCA Dilatation Catheter
  • Manufacturer
    Cordis Corporation

Manufacturer

Cordis Corporation