Events

Rappel de ClinActiv and ClinActiv Plus Therapy Surface (used to provide pressure relief to aid in the prevention and treatment of pressure ulcers)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Hill-Rom 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-2013-RN-01108-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-11-04
  • 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-2013-RN-01108-1
  • 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
    Hill-rom has become aware of a possible hazardous situation when silicon oil contained in the vario sensor within the clinactiv therapy surface is accidentally released. when the pocket of silicone oil is subjected to excessive mechanical stress, it may disconnect and leak oil outside the mattress enclosure and onto the floor.
  • Action
    Hill-Rom is providing additional cleaning instructions on cleaning silicon oil from affected surfaces, and advising users to ensure the Vario sensor is replaced every 3 years. This action has been close-out on 11/02/2016.

Device

ClinActiv and ClinActiv Plus Therapy Surface (used to provide pressure relief to aid in the preve...
  • Modèle / numéro de série
    ClinActiv and ClinActiv Plus Therapy Surface (used to provide pressure relief to aid in the prevention and treatment of pressure ulcers)Model Number: N02050, N02051, P02062, P02063, P02064, P02065All Serial Numbers affectedARTG Number: 130272
  • Manufacturer
    Hill-Rom Pty Ltd

Manufacturer

Hill-Rom Pty Ltd