Events

Safety Alert for KIMGUARD Container Filters

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Kimberly-Clark 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
    2013-03-18
  • Event Date Posted
    2013-03-18
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130318.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: kimberly-clark kimguard container filters medical device manufacturer, kimberly-clark corporation issued a medical device safety alert concerning 9in. x 9in. (23cm x 23cm) square sized kimguard container filters. the affected product code is 68509 and the affected lot numbers are mf1279xxx, mf1287xxx, mf1288xxx. according to the manufacturer, some individual container filter units from the above product lots might contain thin areas that may potentially compromise the ability of the filter to maintain a sterile barrier. complaints received so far involved defects that were identified prior to use of possibly affected instruments or supplies on patients. kimberly-clark stressed that standard practice involves inspecting the sterilization container and filter for sterility breaches prior to use. if the defect is not detected upon standard inspection, contamination of surgical instruments and supplies within the container could be resulted. kimberly-clark asia pacific health care confirmed that the affected products have been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 18 march 2013.

Device

KIMGUARD Container Filters
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Kimberly-Clark KIMGUARD Container Filters
  • Manufacturer
    Kimberly-Clark Corporation

Manufacturer

Kimberly-Clark Corporation