Events

Rappel de Arrow International 4Fg Seldinger Conversion Set with Long Sheath(Peripherally inserted central venous catheter)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Teleflex 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-2015-RN-00729-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-08-12
  • 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-00729-1
  • 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 reason for this action is due to the possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter. the component tabs extend past the opening to the sheath, so even if both tabs break, there will be some length of the sheath that would protrude from the skin. therefore, embolus of the sheath should not occur. the defect is easy to recognise and the clinician would have the choice of either continuing with the split sheath or using a new one. although the issue does not pose a significant risk to the patient, it may cause a delay of treatment when placing the catheter.
  • Action
    Customers are advised not to use or distribute any affected stock and immediately quarantine them. Teleflex Medical will arrange collection of any affected stock from affected facilities. This action has been closed-out on 18/08/2016.

Device

Arrow International 4Fg Seldinger Conversion Set with Long Sheath(Peripherally inserted central v...
  • Modèle / numéro de série
    Arrow International 4Fg Seldinger Conversion Set with Long Sheath(Peripherally inserted central venous catheter)Catalogue number: PI-01451-LSBatch Numbers: 23F14J0437, 23F14K0406, 23F14B0935, 23F14H1535, 23F15A0278, 23F15D0907ARTG Number: 148783
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd