Events

Recall of L-Gel Ultrasound Gel, 5 litre

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Shanghai Shenfeng Medical & Health Articles Co Ltd.

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
    13372
  • Event Initiated Date
    2012-09-04
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Regional Health Ltd, 6 Laurenson Road, Hobsonville, Auckland 0618
  • Reason
    Testing by the tga has determined general microbial counts exceeding the australian microbial standards for medicines (tgo77). such microbial levels consitute a moderate to serious health hazard for infection, expecially if the gel is used for a non-intended purpose, e.G. an invasive procedure.
  • Action
    Product to be returned to supplier

Device

L-Gel Ultrasound Gel, 5 litre

Manufacturer

Shanghai Shenfeng Medical & Health Articles Co Ltd
  • Source
    NZMMDSA