Events

Rappel de Pressure Care Medical Mattresses and Mattress Covers

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

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-01408-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-10-31
  • 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-01408-1
  • 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
    An issue has been identified where defective labels on the printed mattress covers at the foot of the mattress may let liquid through the cover material into the foam mattress and may produce a very low risk of contamination of the mattress. the risk of infection from this defective label to a patient is very small and very unlikely.
  • Action
    The Comfort Group is advising customers to quarantine affected stock. Collection of affected products and replacement with unaffected goods will take place as soon as possible.

Device

Pressure Care Medical Mattresses and Mattress Covers
  • Modèle / numéro de série
    Pressure Care Medical Mattresses and Mattress CoversNP200 Mattress Cover onlyNP200W90E Pressure Care MattressNP200W90NE Pressure Care MattressManufactured between 01 June 2014 and 31 January 2016ARTG Numbers: 261172, 260051
  • Manufacturer
    Australian Comfort Group

Manufacturer

Australian Comfort Group