Events

Recall of Paratherm Heater Cooler Unit

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Australian Blood Management Unit Trust.

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-2018-RN-00646-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2018-05-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00646-1
  • 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
    Updated instructions for use (ifu) and cleaning guidelines for the paratherm heater cooler unit have been released.There was a safety alert communicated in april 2017 which referenced the interim cleaning and disinfecting guidelines. during the last 12 months, validation efforts have been undertaken by the manufacturer chalice medical to support the use of a hydrogen peroxide based disinfection agent. this disinfection agent has been subject to review and subsequent inclusion in the australian register of therapeutic goods (amity hp 75, artg 302115, supplied by lovell surgical supplies international as the local sponsor).
  • Action
    Amity HP 75 is to be made commercially available in Australia in June 2018. Stock is currently being manufactured and shipped to Australia. Once available in Australia, Australian Blood Management Unit Trust will be able to facilitate supply of this disinfection agent through Lovell Surgical Supplies International.

Device

Paratherm Heater Cooler Unit

Manufacturer

Australian Blood Management Unit Trust
  • Source
    DHTGA