Events

Recall of Medicina Low Profile Gastrostomy Button

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Australasian Medical & Scientific 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-2015-RN-00042-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-01-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00042-1
  • 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
    Australasian medical & scientific ltd (amsl) is informing the customers that the safety and performance of these devices have not been properly evaluated and so the ce marking of the device is not valid.
  • Action
    AMSL is requesting the customers to inspect the stock and quarantine all units. AMSL will arrange for the affected stock to be recovered and a credit note issued. This action has been closed-out on 15/07/2016.

Device

Medicina Low Profile Gastrostomy Button

Manufacturer

Australasian Medical & Scientific Ltd