Events

Rappel de ReNew Reusable Tips (Scissors, Graspers and Dissectors)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par C R Kennedy & Co 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-01152-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-09-21
  • 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-01152-1
  • 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
    Microline surgical has received customer reports that the heat-shrink insulation tube of renew reusable scissor, grasper and dissector tips may split during autoclave sterilisation/re-sterilisation. if a split occurs, the heat-shrink could fall off during a surgical procedure and if cautery is needed, there is a potential for burn due to insulation failure.This issue is due to a malfunction related to the heat-shrink insulation tube that is located immediately proximal to the metal tip.
  • Action
    1. Users are to complete and return the supplied response form to the sponsor, even if the affected goods are no longer in possession. 2. A CR Kennedy Representative will contact customers to: a. Provide directions to initiate an RMA (Returned Material Authorisation) for the return of the ReNew Reusable tips at your facility. b. Discuss the availability of ReNew Disposable Tips that are counterparts to the Reusable items (where applicable). c. Organise a credit for all product returns to customer accounts.

Device

ReNew Reusable Tips (Scissors, Graspers and Dissectors)
  • Modèle / numéro de série
    ReNew Reusable Tips (Scissors, Graspers and Dissectors)All Product CodesARTG Number 192108
  • Manufacturer
    C R Kennedy & Co Pty Ltd

Manufacturer

C R Kennedy & Co Pty Ltd