Events

Rappel de Omrix Pressure Regulator (Surgical air pipeline regulator)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Johnson & Johnson Medical 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-2014-RN-00937-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-08-26
  • 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-2014-RN-00937-1
  • 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
    Omrix biopharmaceuticals has identified that there may be pressure regulators in the field with an incorrect connector type. a nitrous oxide connector has been supplied instead of a carbon dioxide connector (sis-co2 connector). the connector has a different colour (grey and not green-grey, as should be according to the australian standard- as 2896- for medical gas systems ) and in addition, instead of carbon dioxide, it was engraved with “nitrous oxide’’. johnson & johnson medical pty limited (jjm) is recalling omrix pressure regulators. the nitrous oxide inlet connector is not compatible with carbon dioxide source connector and can therefore not connect to omrix pressure regulator.
  • Action
    Johnson & Johnson Medical Pty Limited is requesting the customers to quarantine the affected pressure regulators. Arrangements will be made for a courier to pick up the affected product and a credit note issued. This action has been closed-out on 22/03/2016.

Device

Omrix Pressure Regulator (Surgical air pipeline regulator)
  • Modèle / numéro de série
    Omrix Pressure Regulator (Surgical air pipeline regulator)Product Codes: EVRC68 and EVR54CARTG Number: 203072
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd