Events

Rappel de Sorin 1T & 3T Heater Cooler (Perfusion system)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Cellplex 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-00511-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-06-16
  • 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-00511-1
  • 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
    Sorin has become aware that the actual disinfection practices and the water maintenance that some users have been performing are not always conducted according to our instructions for use. without vigilant performance of the disinfection and maintenance procedures per the instructions for use, organisms can multiply in a heater cooler device and potentially form biofilm.
  • Action
    Sorin Group is providing end users with additional instructions for cases where the heater cooler has not been maintained according to the Instructions for Use. The IFU has also been updated to include the additional cleaning instructions. This action has been closed-out on 14/07/2016.

Device

Sorin 1T & 3T Heater Cooler (Perfusion system)
  • Modèle / numéro de série
    Sorin 1T & 3T Heater Cooler (Perfusion system)All serial numbers starting with 16SXxxxx are affectedARTG Number: 194514
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    Cellplex Pty Ltd

Manufacturer

Cellplex Pty Ltd