Events

Rappel de 4F Stiffened Micro-Introducer Kits (guidewire or catheter introducer) Product Description: STF 4F M.I. KIT 45CM NT/T ECHO S PG

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Medical Specialties 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-2016-RN-01295-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-10-11
  • 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-01295-1
  • 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
    Angiodynamics, inc., the manufacturer of the 4f stiffened micro-introducer kits, has become aware of the potential with respect to the 4f sheath/dilator components for the rotating luer to detach from the dilator hub during use.Use of the affected angiodynamics stiffened micro-introducer kits may result in patient harm, including minor tissue trauma and/or minor delay in procedure to replace the device.
  • Action
    Medical Specialties Australia have contacted affected customers and retrieved all unused product. This action has been closed-out on 24/05/2017.

Device

4F Stiffened Micro-Introducer Kits (guidewire or catheter introducer) Product Description: STF 4F...
  • Modèle / numéro de série
    4F Stiffened Micro-Introducer Kits (guidewire or catheter introducer)Product Description: STF 4F M.I. KIT 45CM NT/T ECHO S PGCatalogue Number: 06597052Lot Numbers: 5031722 & 5043440ARTG Number: 172522
  • Manufacturer
    Medical Specialties Australia Pty Ltd

Manufacturer

Medical Specialties Australia Pty Ltd
  • Source
    DHTGA