Events

Safety Alert for Correct Plus Bite Superfast

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
    2012-07-11
  • Event Date Posted
    2012-07-11
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120711a.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 ultra fabric reinforced surgical gown x-large, sterile medical device manufacturer, pentron clinical issued a medical device safety alert concerning correct plus bite superfast. the affected part numbers are q34ia and q34ic. according to the manufacturer, the current directions for use (dfu) for correct plus bite superfast lists a working time that is not indicative of the actual performance of the product. the current dfu lists the total working time as 25 seconds, while the material actually provides a minimum working time of 15 seconds as outlined in the chart below: the manufacturer explained that there are no safety or efficacy concerns associated with correct plus bite superfast. for details, please refer to the attachment. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 july 2012.

Device

Correct Plus Bite Superfast
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Pentron Clinical Correct Plus Bite Superfast
  • Manufacturer
    Kimberly-Clark

Manufacturer

Kimberly-Clark