Events

Safety Alert for L-Gel Ultrasound Transmission Gel

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by N/A.

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
    2012-08-17
  • Event Date Posted
    2012-08-17
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120817.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: shanghai shenfeng l-gel ultrasound transmission gel the australia therapeutic goods administration (tga) has issued a recall of all lots of l-gel ultrasound transmission gel manufactured between june 2011 and may 2012 by shanghai shenfeng, china. the gel is supplied in 250ml and 5l bottles. the recall was initiated after tga tests found bacterial contamination (burkholderia cepacia, stenotrophomonas maltophilia and raoultella planticolla) in lot numbers 2011 06 17 to 2012 04 09 of the product. there is a small risk that patients who have been exposed to contaminated l-gel ultrasound transmission gel may develop an infection, this infection will usually be in the area where the gel was used. stop using l-gel ultrasound transmission gel products with lot numbers 2011 06 17 to 2012 04 09. identify patients who have been exposed to these lots of l-gel ultrasound transmission gel. review the procedures they underwent and the outcomes of the procedures, and take further action as necessary. for details, please refer to tga website: http://www.Tga.Gov.Au/safety/alerts-device-l-gel-120816.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 17 august 2012.

Device

L-Gel Ultrasound Transmission Gel
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Shanghai Shenfeng L-Gel Ultrasound Transmission Gel
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    DH