Events

Rappel de Polyurethane Nasogastric Feeding 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 REM Systems 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-2014-RN-00561-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-05-22
  • 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-2014-RN-00561-1
  • 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
    The manufacturer, pacific hospital supply company, has determined that in certain lot numbers, after a number of times where routine folding of the tube occurs, the folding site has split which has resulted in leakage from the tube. the stretching during folding can produce a tensile (pulling) force which breaks the bonding between the two surfaces.
  • Action
    Users are asked to immediately check their facility’s inventory for the affected lot numbers and quarantine any of the affected products. Await instructions from REM SYSTEMS Pty Ltd for the return and replacement of the affected product. This action has been closed-out on 02/02/2016.

Device

Polyurethane Nasogastric Feeding Tube
  • Modèle / numéro de série
    Polyurethane Nasogastric Feeding TubeItem Numbers: PH-05100PU, PH-06100PU, PH-06125PU, PH-08100PU PH-08125PU Lot Numbers : 14004121, 13022911, 14004123, 13022912, 14004125, 13022915, 14004130, 13022913, 14004132 and 13022916 ARTG Number: 204612
  • Manufacturer
    REM Systems Pty Ltd

Manufacturer

REM Systems Pty Ltd