Events

Recall of Meducore Easy Automatic External Defibrillator (AED) - Battery Pack

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by USL Medical 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-2017-RN-00281-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-05-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00281-1
  • 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
    An issue has been identified that in rare cases, the meducore easy battery pack may fail. in the event of failure, it would no longer be possible to administer a shock to the patient, which could lead to unsuccessful resuscitation.
  • Action
    USL Medical will be providing users with a replacement battery. Once the replacement battery is received, users are to immediately remove and discard the affected battery and insert the new battery into the device. Whilst waiting on the replacement battery, USL Medical recommends close monitoring of the status indicators on the front of the Meducore Easy AED to ensure battery and device readiness.

Device

Meducore Easy Automatic External Defibrillator (AED) - Battery Pack
  • Model / Serial
    Meducore Easy Automatic External Defibrillator (AED) - Battery PackBattery Pack Model Number: WM 40155Serial Numbers: 15120, 15122, 15127, 15121, 15119, 15126, 15118, 15117, 15116 & 15128ARTG Number: 214662
  • Manufacturer
    USL Medical Pty Ltd

Manufacturer

USL Medical Pty Ltd