Events

Rappel de Ventricular Catheter Accessory Kit (used for external cerebrospinal fluid (CSF) drainage)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Integra Neurosciences 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-2016-RN-01139-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-08-29
  • 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-2016-RN-01139-1
  • 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
    The manufacturer has identified that there is a possibility of an incomplete seal of the product packaging in one specific lot of the ventricular catheter accessory kit. the packaging defect can impact both the inner and outer seals of the product resulting in the possibility that the sterility assurance may be compromised. to date, there have been no complaints submitted and no adverse events reported due to a compromised seal.
  • Action
    Integra is advising users to inspect inventory and quarantine any remaining units of the affected stock. Affected product will be replaced with unaffected stock. This action has been closed-out on 16/02/2017.

Device

Ventricular Catheter Accessory Kit (used for external cerebrospinal fluid (CSF) drainage)
  • Modèle / numéro de série
    Ventricular Catheter Accessory Kit (used for external cerebrospinal fluid (CSF) drainage)Catalogue Number: 951303Lot Number: 0195786ARTG Number: 172182
  • Manufacturer
    Integra Neurosciences Pty Ltd

Manufacturer

Integra Neurosciences Pty Ltd