Events

Recall of Feather Touch Vinyl Examination Gloves

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Pro-Pac Packaging Aust 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-01292-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-09-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01292-1
  • 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 feather touch vinyl examination gloves are not suitable for medical/biological applications because they do not provide an effective barrier suitable for medical or biological protection.
  • Action
    Pro-Pac Packaging is advising retailers and distributors to immediately quarantine all Feather Touch Vinyl Examination Gloves with ARTG # 160255 printed on the box, and to contact Pro-Pac who will arrange for the stock to be recovered and replacement stock, or a credit note to be issued. This action has been closed-out on 18/05/2017.

Device

Feather Touch Vinyl Examination Gloves

Manufacturer

Pro-Pac Packaging Aust Pty Ltd
  • Source
    DHTGA