Events

Rappel de A3/A5 Anesthesia Delivery System

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Ulco Engineering 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-2012-RN-01161-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-12-21
  • 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-2012-RN-01161-1
  • 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
    There is the possibility of a system leak resulting from improper seating of the co2 absorbent canister gasket. should a system leak occur during use, fresh gas flow may be increased to compensate for any pressure loss resulting from the leak while the absorbent canister is unlocked, and locked again to reseat the gasket. if the co2 absorbent gasket is improperly seated, however a potential leak will likely present itself during the automatic circuit leak and compliance test performed at startup and the manual leak test recommended to be performed before each case, at which time the absorbent canister can be unlocked and locked again to reseat the gasket.This recall action was not notified to the tga before it was initiated by ulco medical.
  • Action
    Ulco Medical is providing work around instructions and will be replacing the canister gasket to permanently correct the issue.

Device

A3/A5 Anesthesia Delivery System

Manufacturer

Ulco Engineering Pty Ltd
  • Source
    DHTGA