Events

Rappel de Super Arrow-Flex Percutaneous Sheath Introducer Set

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-2016-RN-00113-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-01-28
  • 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-00113-1
  • 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 potential packaging damage where the outer packaging may exhibit scratches or pin holes. therefore, the sterility of the product cannot be guaranteed. if a non-sterile product is used, there is potential for infection to occur. no patient injuries have been reported related to this issue.
  • Action
    Teleflex is advising users to quarantine any affected stock for return to Teleflex. A credit note will be issued for stock returned. This action has been closed-out on 25/01/2017.

Device

Super Arrow-Flex Percutaneous Sheath Introducer Set
  • Modèle / numéro de série
    Super Arrow-Flex Percutaneous Sheath Introducer SetSAP/Catalogue Numbers: CL-07635, CL-07735 and CL-07835Multiple batch numbers affectedARTG Number: 135922
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd