Events

Rappel de Inhalo Medical Oxygen with Integrated Pressure Regulator/FlowmeterBOC

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

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-2017-RN-00215-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-02-13
  • 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-2017-RN-00215-1
  • 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
    The pressure gauges supplied to boc as part of the inhalo device, may in rare circumstances, have a broken pointer. this failure mode may result in the gauge pointer moving independently of actual cylinder pressure. this will result in inaccurate pressure readings being observed. the situation has been observed where, with a cylinder in a vertical position, the pressure gauge pointer can indicate the cylinder is full, when in fact there is reduced content within the cylinder.
  • Action
    Customers are advised to confirm that the stock they are using is not faulty and has sufficient contents to administer therapy i.e., all 400CD Inhalo cylinders will need to be checked prior to use as per the Pressure Gauge Check work instruction provided with the customer letter. If no fault is identified, customers can continue to use the product, there is no need to contact BOC. If a faulty pressure gauge is identified, please contact BOC immediately for a free of charge replacement. BOC has implemented additional product testing prior to release from their filling sites, however there is a remote possibility that a pressure gauge pointer may fail during transit/handling.

Device

Inhalo Medical Oxygen with Integrated Pressure Regulator/FlowmeterBOC
  • Modèle / numéro de série
    Inhalo Medical Oxygen with Integrated Pressure Regulator/FlowmeterBOC Product Code: 400CDARTG Number: 187646
  • Manufacturer
    BOC Limited

Manufacturer

BOC Limited