Events

Recall of Deluxe First Aid Kit

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Uniwide Australia Import Export 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-01515-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-11-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01515-1
  • 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
    The deluxe first aid kit is supplied with a leaflet containing poorly written first aid instructions which cannot be relied upon in an emergency. some of the information provided in the leaflet is unsuitable and not in line with australian first aid protocols.
  • Action
    Uniwide is advising customers to return affected stock for a credit note. This action has been closed-out on 28/02/2018.

Device

Deluxe First Aid Kit

Manufacturer

Uniwide Australia Import Export Pty Ltd
  • Source
    DHTGA