Safety Alert for ULTRA Fabric Reinforced Surgical Gown X-Large, Sterile

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

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
  • Event Date Posted
  • Event Country
  • Event Source
  • 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: kimberly-clark ultra fabric reinforced surgical gown x-large, sterile medical device manufacturer, kimberly-clark issued a medical device safety alert concerning ultra fabric reinforced surgical gown x-large, sterile. kimberly-clark has determined that the package seam of the above mentioned products may not remain properly sealed to ensure that the contents of the package are sterile. therefore, the affected products might not be sterile as labeled. kimberly-clark further explained that the package includes a caution statement indicating ‘contents sterile. unless this package is opened or damaged.’ the direct risk associated with this potential failure mode is that use of an affected non-sterile gown in surgery could lead to contamination of the surgical field. however, as the user inspects each package prior to use, the likelihood for use of a non-sterile gown in surgery is considered to be remote. according to kimberly-clark, the affected lots have been distributed in hong kong. kimberly-clark advised the affected users to stop using the impacted product lots. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 10 july 2012.


  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Kimberly-Clark ULTRA Fabric Reinforced Surgical Gown X-Large, Sterile
  • Manufacturer