Safety Alert for Sterile Chlorohexidine Gluconate/Alcohol Swabs, Sterile Alcohol Swabs and Sterile Povidine Iodine Swabs

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Medical Industries Australia Pty Ltd..

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
    2013-08-26
  • Event Date Posted
    2013-08-26
  • 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: sterile chlorohexidine gluconate/alcohol swabs, sterile alcohol swabs and sterile povidine iodine swabs distributed by medical industries australia the therapeutic goods administration (tga), australia posted an medical device safety alert concerning sterile chlorohexidine gluconate/alcohol swabs, sterile alcohol swabs and sterile povidine iodine swabs distributed in the australia by medical industries australia pty ltd., a subsidiary of alpine medical pty ltd. the swabs have been mislabelled sterile and sold on the market. this recall action was carried out prior to approval of the recall strategy by the tga. medical industries australia is requesting wholesalers to return affected stock. for details, please refer to tga websitehttp://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-00887-1 if you are in possession of the product, please contact your supplier for necessary actions. posted on 26 august 2013.

Device

  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Sterile Chlorohexidine Gluconate/Alcohol Swabs, Sterile Alcohol Swabs and Sterile Povidine Iodine Swabs distributed by Medical Industries Australia
  • Manufacturer

Manufacturer