Events

Rappel de Portex Thoracic Catheter and Connecting Tube

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Smiths Medical Australasia 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-00357-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-04-24
  • 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-00357-1
  • 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
    Smiths medical became aware of a potential breach in the seal of the package on certain packaging lots. these packages were used in the manufacturing of certain portex thoracic catheters and connecting tubes, compromising the sterility of the devices. smiths medical has not received any reports of serious injury relating to this issue.
  • Action
    Smiths Medical is advising customers to quarantine all stock of the affected units. Upon receipt of a completed Response Form provided with the Customer Letter, a Smiths Customer Service Representative will contact users with a Return Material Authorisation Number to facilitate the return of the product and issue a credit.

Device

Portex Thoracic Catheter and Connecting Tube
  • Modèle / numéro de série
    Portex Thoracic Catheter and Connecting TubeThoracic Catheter 28Fangled Soft, Adult Connector, 10/CAModel Number: 200/812/280Multiple Lot NumbersARTG Number: 145749Smiths Medical Australasia - Portex Thoracic Catheter - Drain, thoracic
  • Manufacturer
    Smiths Medical Australasia Pty Ltd

Manufacturer

Smiths Medical Australasia Pty Ltd