Events

Rappel de Pennine Healthcare Ryles Tubes (used for enteral feeding)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Bosco Medical Australia.

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-2016-RN-01156-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-09-12
  • 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-2016-RN-01156-1
  • 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
    Bosco medical australia pty ltd have been notified by the manufacturer that there is a possibility that a tube could have the print graduations running the wrong way, i.E. they decrease with distance from the tip of the tube, when the correct orientation is that the numbers increase with distance from the tip of the tube. there is the potential for misplacement of the tubes if the print graduations are used as the sole means for confirming the placement of the ryles tube.
  • Action
    Bosco Medical is advising users to inspect the graduations of the tubes prior to insertion. If affected product is found, replace with unaffected product and contact Bosco for credit or replacement.

Device

Pennine Healthcare Ryles Tubes (used for enteral feeding)
  • Modèle / numéro de série
    Pennine Healthcare Ryles Tubes (used for enteral feeding)Multiple products affected Product Codes: RT-2008/L, RT-2010/L, RT-2012/L, RT-2014/L, RT-2016/L, RT-2018/L, RT-2314, RT-2316All Lot Numbers affectedARTG Number: 144359
  • Manufacturer
    Bosco Medical Australia

Manufacturer

Bosco Medical Australia