Events

Recall of Pico 70 Arterial blood sampler (used with Radiometer Blood Gas Analysers)

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-2016-RN-01500-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-11-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01500-1
  • 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
    Radiometer has recently become aware of a potential issue with the pico 70 arterial blood sampler, 956-522 of lot rw-55. it has been reported overseas that some needles seem to be corroded. the use of an arterial blood sampler contaminated with rust particles could lead to blood stream infection and organ damage. to date, no incidences have been reported in australia.
  • Action
    Radiometer is requesting customers to quarantine stock from lot 956-522RW55. Radiometer will arrange for the collection of the affected product and replacement of this stock. Patients that have been exposed to the affected lot of Pico 70 Arterial blood sampler should be closely monitored for signs of infection or other adverse events. This action has been closed-out on 28/02/2018.

Device

Pico 70 Arterial blood sampler (used with Radiometer Blood Gas Analysers)
  • Model / Serial
    Pico 70 Arterial blood sampler (used with Radiometer Blood Gas Analysers) Lot Number: 956-522RW55ARTG Number: 135319
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd