Safety Alert for Extrude Wash

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
    2012-06-08
  • Event Date Posted
    2012-06-08
  • Event Country
  • Event Source
    DH
  • Event Source URL
  • 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 extrude wash medical device manufacturer, kerr corporation, has issued a customer notification on extrude wash, part no. 28418 - 2 pack, 28419 - 32 pack and 29036 - value pack (all production lots within shelf life). kerr corporation found that the current direction for use for extrude wash lists a working time that is not indicative of the actual performance of the product. there is no safety or efficacy concerns associated with extrude wash as the product will set. according to the manufacturer, the affected products have been distributed in hong kong. if you are in possession of the product, please contact your supplier for necessary actions. posted on 8 june 2012.

Device

  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Kerr Extrude Wash
  • Manufacturer

Manufacturer