Events

Rappel de The ARROWg+ard Blue PLUS antimicrobial 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-2018-RN-00358-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-04-30
  • 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-00358-1
  • 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
    It has been identified that certain product may have packaging that is not sealed. in the event the packaging is compromised in this manner, sterility of the product cannot be guaranteed. if a non-sterile product is used, there is potential for an infection to occur. to date, teleflex medical has not received reports of this issue in australia.
  • Action
    Teleflex is advising customers to inspect inventory for impacted lots and identify any units that appear to be affected. These units should then be discarded and Teleflex will provide a suitable credit following receipt of the acknowledgement form suppled with the customer letter.

Device

The ARROWg+ard Blue PLUS antimicrobial catheter
  • Modèle / numéro de série
    The ARROWg+ard Blue PLUS antimicrobial catheterMultiple Lot NumbersARTG Numbers: 138302, 136923, 278735, 278926 and 279697
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd