Events

Rappel de Various Safeset and Transpac Blood Pressure Transducer Sets

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par ICU Medical Australia 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-2017-RN-01237-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-10-09
  • 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-01237-1
  • 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
    Icu medical has identified a potential for detachment or separation of pressure tubing/luer bonded connections on specific blood pressure tranducer sets. icu medical has received reports due to this issue and there is the potential for serious injury. as a precaution, icu medical is recalling the affected devices.
  • Action
    ICU Medical is advising users to inspect stock and quarantine all affected units. Any remaining affected stock will be returned and replaced or a credit note issued.

Device

Various Safeset and Transpac Blood Pressure Transducer Sets
  • Modèle / numéro de série
    Various Safeset and Transpac Blood Pressure Transducer SetsMultiple Products, Item and Lot Numbers affectedARTG Number: 195624
  • Manufacturer
    ICU Medical Australia Pty Ltd

Manufacturer

ICU Medical Australia Pty Ltd
  • Source
    DHTGA