Events

Rappel de Transpac 4 Disposable Pressure Transducer Monitoring Kit

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Philips Electronics Australia 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-2017-RN-00015-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-01-06
  • 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-00015-1
  • 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
    Certain lots of the transpac 4 disposable pressure transducer monitoring kit may have the potential to leak or potentially introduce small amounts of air into the line. this could result in potential harm to the patient due to blood loss, introduction of air into the line or contamination of intravenous fluid. there is also potential harm to the user as a result of exposure to blood borne pathogens.
  • Action
    Philips is advising users to discontinue use of affected products and to check their inventory for affected stock. Affected stock is to be quarantined and users are requested to contact Philips prior to returning the affected products in order to receive a credit. This action has been closed-out on 01/03/2018.

Device

Transpac 4 Disposable Pressure Transducer Monitoring Kit
  • Modèle / numéro de série
    Transpac 4 Disposable Pressure Transducer Monitoring KitProduct Number: 989803177901Lot Numbers: 3239500, 3247905Product Number: 989803194641Lot Number: 3258299ARTG Number: 197576
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DHTGA