Safety Alert for Ultrasound Gel

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Yafho Bio-Technology Co Ltd; and/or Linmed Medical Co 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
  • 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: meditech ultrasound gel the therapeutic goods administration (tga) of australia has issued a medical device safety alert concerning ultrasound probe cover (telescopic folded with gel); and all products labelled meditech and manufactured by: yafho bio-technology co ltd; and/or linmed medical co ltd. [part number/ order code: 88654012; lot number: 201701]. meditech systems asia pacific has become aware that the product ultrasound probe cover (telescopic folded with gel) may be contaminated with burkholderia cenocepacia. whilst no other batches or pack sizes of this product have been supplied by meditech, users are further advised that all products labelled meditech and manufactured by: yafho bio-technology co ltd; and/or linmed medical co ltd. are also affected by this recall. users are advised that all product labelled meditech and manufactured by yafho bio-technology co ltd and/or linmed medical co ltd, including all stock of ultrasound probe cover (telescopic folded with gel) should quarantined immediately and recalled from the market. for details, please refer to the tga websites: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2017-rn-00631-1 https://www.Tga.Gov.Au/alert/meditech-ultrasound-gel if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 may 2017.