Events

Safety Alert for AlgiNot Cartridge, AlgiNot Cartridge FS, AlgiNot Volume and AlgiNot Volume FS

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Kerr 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
    2012-06-27
  • Event Date Posted
    2012-06-27
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120627b.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: kerr alginot cartridge, alginot cartridge fs, alginot volume and alginot volume fs medical device manufacturer, kerr corporation, has issued a medical device safety alert concerning alginot cartridge, alginot cartridge fs, alginot volume and alginot volume fs. they found that the current instructions for use (ifus) for alginot include product specifications and instructions that are not indicative of the actual performance of the product. the ifus incorrectly state the work time/mouth removal time. according to the local supplier, the affected devices were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 27 june 2012.

Device

AlgiNot Cartridge, AlgiNot Cartridge FS, AlgiNot Volume and AlgiNot Volume FS
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Kerr AlgiNot Cartridge, AlgiNot Cartridge FS, AlgiNot Volume and AlgiNot Volume FS
  • Manufacturer
    Kerr Corporation

Manufacturer

Kerr Corporation