Events

Rappel de Various Terumo Introducer Kits Glide Shealth Slender Radifocus Introducer II (Femoral) Radifocus Introducer II M Coat (Transradial)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Terumo 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-00713-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-05-29
  • 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-00713-1
  • 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
    Terumo has identified an issue where a potential loss of package integrity may compromise the sterility of the introducer kits. an incomplete seal in the kit's peel pouch was observed during a routine internal inspection by terumo. terumo has not received any customer complaints or reported patient injuries as a result of this issue. the potential incidence rate is estimated to be less than 0.02%.
  • Action
    Terumo is advising users to quarantine and destroy all product from the affected lots. Terumo will provide credit for destroyed product within the affected lots.

Device

Various Terumo Introducer Kits Glide Shealth Slender Radifocus Introducer II (Femoral) Radifocus ...
  • Modèle / numéro de série
    Various Terumo Introducer Kits Glide Shealth SlenderRadifocus Introducer II (Femoral)Radifocus Introducer II M Coat (Transradial)Multiple Product Codes and Lot NumbersARTG Number: 126256
  • Manufacturer
    Terumo Australia Pty Ltd

Manufacturer

Terumo Australia Pty Ltd