Events

Rappel de HOTLINE Fluid Warming 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 Smiths Medical Australasia 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-00344-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-03-18
  • 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-00344-1
  • 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
    Smiths medical has become aware of an issue with a limited number of warming sets with the potential for leakage form the injection port at the top of the warming set. if fluid leaks at the injection port, the leak is readily detectable by the clinician who would stop using the warming set and obtain a replacement. this could present a minor delay in therapy while a replacement warming set is obtained.
  • Action
    Smiths Medical is requesting their customers to segregate all affected units. Upon confirmation of the location of affected units a service representative will arrange for the exchange of unused warming sets. This action has been closed-out on 31/08/2016.

Device

HOTLINE Fluid Warming Sets
  • Modèle / numéro de série
    HOTLINE Fluid Warming SetsProduct Codes: L-70 and L-80Multiple lot numbers affected ARTG Number: 99436
  • Manufacturer
    Smiths Medical Australasia Pty Ltd

Manufacturer

Smiths Medical Australasia Pty Ltd