Events

Rappel de Prelude SNAP Splittable Sheath IntroducerVascular Introducer Kit

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Merit 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-2017-RN-01511-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-12-22
  • 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-2017-RN-01511-1
  • 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
    Merit medical systems, inc. is conducting a recall of specific lots of prelude snap splittable sheath introducers due to an intermittent failure of the splittable hub. merit medical has received complaints indicating that the wings on certain lots of the prelude snap have broken off the sheath hub during splitting. this will likely result in a minor delay in procedure. although rare, this could also result in a pacing lead/catheter displacement, air embolus, or minor hemorrhage. merit has received no reports of patient harm or injury as a result of this issue.
  • Action
    Users are advised to check inventory for affected devices and discontinue their use. Affected stock should be returned to Merit Medical.

Device

Prelude SNAP Splittable Sheath IntroducerVascular Introducer Kit
  • Modèle / numéro de série
    Prelude SNAP Splittable Sheath IntroducerVascular Introducer KitMultiple Catalogue and Lot Numbers AffectedARTG 278434
  • Manufacturer
    Merit Medical Australia Pty Ltd

Manufacturer

Merit Medical Australia Pty Ltd