Events

Rappel de RPK-01 Luer Connector

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Tekmed 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-00251-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2018-03-28
  • 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-2018-RN-00251-1
  • 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 there is a difficulty connecting the female luer to haemodialysis blood tubing lines, end caps and syringes which may result in blood or air leakage at the connection site. to date, there have been no reports of injury in australia as a result of this issue.
  • Action
    TekMed is requesting customers immediately review their stock on hand for affected units and to discontinue their use and distribution. Affected product should be returned to TekMed who will issue a suitable account credit. New unaffected product is currently being manufactured.

Device

RPK-01 Luer Connector
  • Modèle / numéro de série
    RPK-01 Luer Connector Lot Number: MCCC310Expiry Date:13-10-2021ARTG Number:145174 (Tekmed - Medcomp Long-term Implantable Haemodialysis Catheter Packs - Catheter, haemodialysis, implantable)
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Manufacturer
    Tekmed Pty Ltd

Manufacturer

Tekmed Pty Ltd