Events

Rappel de Arterial Cannulae and Customised Tubing Packs including the 3/8” Vent plug 70000.8256

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Getinge 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-2018-RN-00435-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2018-05-09
  • 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-2018-RN-00435-1
  • 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
    An arterial cannula used for open heart surgery is normally equipped with a vent plug, which facilitates the de-airing of the cannula.The vent plug of our arterial cannula consists of sintered polyethylene, therefore the structure of the vent plug is porous and gas-permeable. after the de-airing process is completed the customer has to separate the vent plug from the cannula to connect the extracorporeal circuit.Getinge has been made aware that in some instances, the vent plug can break during the separation from the arterial cannula.
  • Action
    Getinge is advising customers to immediately return affected product to their local Getinge representative. Due to the discontinuation of the Surgical Perfusion Catheters/Cannulae product portfolio, Getinge are not providing replacement.

Device

Arterial Cannulae and Customised Tubing Packs including the 3/8” Vent plug 70000.8256
  • Modèle / numéro de série
    Arterial Cannulae and Customised Tubing Packs including the 3/8” Vent plug 70000.8256Multiple Material NumbersARTG Number: 206768Getinge Australia - Catheter, intravascular, general-purpose
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

Getinge Australia Pty Ltd
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    DHTGA