Events

Recall of Level 1 Fast Flow Fluid Warmers with and without Air Detection

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Smiths Medical Australasia 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-2013-RN-00091-2
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-01-31
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00091-2
  • 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
    A limited number of fluid warmers were manufactured with an incorrect printed circuit board component which could prevent the fluid warmer from functioning as intended and also potentially exhibiting a false over temperature alarm.
  • Action
    Smiths Medical Australasia is requesting users to identify any affected units and place in quarantine. A Biomedical Technician will inspect devices to determine if they are affected and provide a correction.

Device

Level 1 Fast Flow Fluid Warmers with and without Air Detection
  • Model / Serial
    Level 1 Fast Flow Fluid Warmers with and without Air Detection Item Code: H-1200Affected Serial Numbers: S103A00028, S103A00029, S103A00094 and S103A00095ARTG Number: 108420
  • Manufacturer
    Smiths Medical Australasia Pty Ltd

Manufacturer

Smiths Medical Australasia Pty Ltd