Events

Recall of Military Trauma & Haemorrhage Wound Dressing, size 10 x 17cm

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Aero Healthcare.

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-00370-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-04-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00370-1
  • 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 device is typically used to protect wounds and arrest bleeding in an emergency situation. it consists of a pad attached to a roll bandage. the pad is applied directly to the wound and the bandage is subsequently wrapped around the pad. a pressure bar mechanism provides pressure to the wound site. it has been reported that the pressure bar material from a specific batch has inadequate strength and may break during use.
  • Action
    Aero Healthcare is advising customers to inspect stocks and quarantine the affected units prior to their return. This action has been closed-out on 26/05/2017.

Device

Military Trauma & Haemorrhage Wound Dressing, size 10 x 17cm
  • Model / Serial
    Military Trauma & Haemorrhage Wound Dressing, size 10 x 17cmBatch number 15051Expiry Date: 31 June 2020ARTG number: 201258
  • Manufacturer
    Aero Healthcare

Manufacturer

Aero Healthcare