Events

Rappel de Pico 70 Arterial blood sampler (used with Radiometer Blood Gas Analysers)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Radiometer Pacific Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2016-RN-01500-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-11-16
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01500-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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)
  • Modèle / numéro de série
    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