Events

Rappel de PORT-A-CATH Plastic Hub Needles, 0.9mm (20G) x 19mm (3/4 in) 90 deg

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-2015-RN-00944-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-09-25
  • 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-00944-1
  • 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 has become aware of a labelling issue with one lot of port-a-cath plastic hub needles. the label on the lid stock of the individual needle package lists the incorrect product reorder number, description and product image. the product reorder number should be 21-2287-24 with a corresponding description and product image, but instead it lists the 21-2005-24 product reorder number, description and product image. the needle inside the individual package is the product reorder no. 21-2287-24 needle and the outer carton label lists the correct reorder number 21-2287-24.
  • Action
    Smiths Medical is advising customers to quarantine affected stock. Any affected stock will be replaced or a credit issued.

Device

PORT-A-CATH Plastic Hub Needles, 0.9mm (20G) x 19mm (3/4 in) 90 deg
  • Modèle / numéro de série
    PORT-A-CATH Plastic Hub Needles, 0.9mm (20G) x 19mm (3/4 in) 90 degProduct re-order Number: 21-2287-24Lot Number: 46262ARTG Number: 145298
  • Manufacturer
    Smiths Medical Australasia Pty Ltd

Manufacturer

Smiths Medical Australasia Pty Ltd