Events

Rappel de Harris Oxygen Flowmeter

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par HGEA 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-2015-RN-00266-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-04-15
  • 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-2015-RN-00266-1
  • 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
    Fisher & paykel healthcare pty ltd is issuing this recall for product correction on behalf of the harris products group as there have been two reports of confusion due to mislabelled measurement lines on the model 86630lox flowmeter. the measurement lines are labelled for arco2 gas and not oxygen gas. there have been no reports of injury to date, however there is potential to set up an incorrect flow of oxygen or air gas to a patient.Note: even though there have been no reports involving the air flow meter, it is being included in this recall as it also uses an arco2 labelled tube.
  • Action
    Harris Products Group is supplying the correction labels to all affected customers. This label is to be affixed to the flow meter to correctly read the flow of Oxygen or Air gas.

Device

Harris Oxygen Flowmeter
  • Modèle / numéro de série
    Harris Oxygen FlowmeterModel Numbers: 86630LOX and 86630LAIR (labelled as “Model 866”)All Lot Numbers ARTG No. 140296
  • Manufacturer
    HGEA Pty Ltd

Manufacturer

HGEA Pty Ltd