Events

Rappel de Catheter Mount

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Fisher & Paykel Healthcare 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-01310-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-10-17
  • 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-01310-1
  • 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
    Fisher & paykel healthcare (fph) has been advised of an increased rate of split tubing cuffs in specific catheter mounts. a split tubing cuff on the catheter mount may potentially cause a leak.To date, fph has not received any reports of adverse events however there is the potential that a leak could lead to patient hypoxaemia if undetected.
  • Action
    Fisher & Paykel Healthcare advises customers to identify any affected lot numbers of the RT021 Catheter Mount from their inventory. Affected products should be destroyed and disposed of.

Device

Catheter Mount
  • Modèle / numéro de série
    Catheter MountModel Number: RT021 Lot Numbers: From 2100089358 to 2100098462; and From 2100190360 to 2100241254ARTG Number: 273356
  • Manufacturer
    Fisher & Paykel Healthcare Pty Ltd

Manufacturer

Fisher & Paykel Healthcare Pty Ltd