Events

Recall of Vinyl examination/treatment glove, non-powdered

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Shantex Pty 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
    RC-2016-RN-01596-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-12-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01596-1
  • 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
    It has been found that shantex vinyl examination gloves have failed to demonstrate compliance with the standard (as.1011:2014) and are not suitable for medical/ biological applications because they do not provide an effective barrier suitable for medical or biological protection.
  • Action
    Shantex is advising the distributor with affected stock to return them for credit. Retailers with affected stock are to return them to the distributor for credit.

Device

Vinyl examination/treatment glove, non-powdered
  • Model / Serial
    Vinyl examination/treatment glove, non-powderedBatch Numbers: 4-2015, 5-2015, 2-2016, 3-2016, 201401, 3-2015ARTG Number: 218314
  • Manufacturer
    Shantex Pty Ltd

Manufacturer

Shantex Pty Ltd