Events

Safety Alert for Catheter Valve

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

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
    2011-11-17
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111117c.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 recall: coloplast catheter valve medical device manufacturer, coloplast, is initiating a medical device recall regarding three lots (2769329, 2799062 and 2823831) of catheter valve (item number: 380851). a sterility test on coloplast catheter valve has failed, which raises concerns over the sterility of the catheter valves. coloplast has not received any complaint on the catheter valve related to this issue and therefore no signals for safety concerns. it is assumed that the catheter valve is used in a non-sterile environment. under this assumption the lack of sterility is very unlike to affect the patient and user’s safety. coloplast is notifying the affected customers. according to the local supplier, the affected devices have been distributed in hong kong. if you are in possession of the affected product, please contact your supplier for the corrective actions.

Device

Catheter Valve
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Coloplast Catheter Valve
  • Manufacturer
    Coloplast

Manufacturer

Coloplast