Events

Recall of L-Gell Ultrasound Transmission Gel – 5ltr & 250mls

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Alpine Medical Pty Ltd T/A Medical Industries Australia.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2012-RN-00792-3
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-08-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00792-3
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Tga's microbial testing of l-gel ultrasound transmission ge shows general microbial count exceeding the microbial standards for medicines (tgo 77) that are intended for cutaneous and mucosal use. such microbial levels constitute a moderate to serious health hazard for infection, especially if the ultrasound transmission gel is used for a non-intended purpose, e.G. an invasive procedure.
  • Action
    Customers to remove stock from use and contact the sponsor to arrange return of product. For more details, please see http://www.tga.gov.au/safety/alerts-device-l-gel-120816.htm .

Device

L-Gell Ultrasound Transmission Gel – 5ltr & 250mls

Manufacturer

Alpine Medical Pty Ltd T/A Medical Industries Australia
  • Source
    DHTGA