Events

Rappel de Paratherm Heater Cooler Unit

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 Blood Management Unit Trust.

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-2018-RN-00646-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2018-05-24
  • 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-2018-RN-00646-1
  • 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
    Updated instructions for use (ifu) and cleaning guidelines for the paratherm heater cooler unit have been released.There was a safety alert communicated in april 2017 which referenced the interim cleaning and disinfecting guidelines. during the last 12 months, validation efforts have been undertaken by the manufacturer chalice medical to support the use of a hydrogen peroxide based disinfection agent. this disinfection agent has been subject to review and subsequent inclusion in the australian register of therapeutic goods (amity hp 75, artg 302115, supplied by lovell surgical supplies international as the local sponsor).
  • Action
    Amity HP 75 is to be made commercially available in Australia in June 2018. Stock is currently being manufactured and shipped to Australia. Once available in Australia, Australian Blood Management Unit Trust will be able to facilitate supply of this disinfection agent through Lovell Surgical Supplies International.

Device

Paratherm Heater Cooler Unit

Manufacturer

Australian Blood Management Unit Trust
  • Source
    DHTGA