Events

Rappel de Reusable Stripper and Cleaver Accessories used with Sureflex and Aura Laser Fibers

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par American Medical Systems 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-2015-RN-00570-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-06-25
  • 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-2015-RN-00570-1
  • 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
    American medical systems (ams) has determined that the validation data related to cleaning instructions and sterilisation methods and the methods defined in instructions for use (ifu) do not meet the new guidance on qualifying reusable products.
  • Action
    AMS is requesting the return of all unused inventory in the field. If the inventory has been used, and has not been discarded, AMS is requesting that the customers discard the devices or return the used device to AMS directly. AMS will be extending a credit to the customers for the purchase price.

Device

Reusable Stripper and Cleaver Accessories used with Sureflex and Aura Laser Fibers
  • Modèle / numéro de série
    Reusable Stripper and Cleaver Accessories used with Sureflex and Aura Laser Fibers Multiple model numbersARTG Numbers: 145536 &169227
  • Manufacturer
    American Medical Systems Australia Pty Ltd

Manufacturer

American Medical Systems Australia Pty Ltd
  • Source
    DHTGA