Events

Recall of Radiometer 905-873 Fixation Kit N20 (used with Radiometer TCM CombiM and Philips TC Gas10 for continuous transcutaneous monitoring of carbon dioxide (tcpCO2) and oxygen (tcpO2) partial pressures)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Radiometer Pacific 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-2015-RN-00636-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-07-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00636-1
  • 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 fixation kit consists of an adhesive which is the interface to the patient’s skin and on the other side, a plastic ring with a sensor retainer mechanism, which allows fastening a tc sensor 84 and tc sensor 54. in some cases, when the operator detaches the fixation ring from the paper liner, fractions of the paper liner’s surface coating sticks to the adhesive surface of the ring. the result is a varying degree of adhesiveness of the ring to the skin. if the ring and sensor fall off, the displaying data on the monitor will not be in range and thus identified by the medical professional. if the sensor is only in partial contact with the patient’s skin it may result in an incorrect measurement.
  • Action
    Customers are advised to check inventory and stock in use for stock of the affected stock and discard them. Radiometer will provide free of charge replacement stock for stock that has been discarded. Users are advised to review customer results where affected stock was used and results were abnormal. This action has been closed-out on 15/08/2016.

Device

Radiometer 905-873 Fixation Kit N20 (used with Radiometer TCM CombiM and Philips TC Gas10 for con...
  • Model / Serial
    Radiometer 905-873 Fixation Kit N20 (used with Radiometer TCM CombiM and Philips TC Gas10 for continuous transcutaneous monitoring of carbon dioxide (tcpCO2) and oxygen (tcpO2) partial pressures)Lot Numbers: 407221, 407241, 407251, 408201, 409231, 410021, 410141, 410281, 411171, 411201, 411261, 412111, 412201, 501081, 501131, 501191, 501311, 502031, 502131, 502171, 502231, 502261, 503091, 503231, 503311, 504081, 504111, 505041, 505141.ARTG Number: 165940
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd