Events

Rappel de Halyard Closed Suction Kits with Flex Connector

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Halyard Australia 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-2018-RN-00232-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2018-04-24
  • 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-00232-1
  • 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
    Halyard australia has been made aware of overseas reports indicating certain flex connectors supplied with 'halyard closed suction with flex connector' devices may become loose or disconnect before use or during use. if disconnection occurs during use, it will result in an open respiratory circuit and interruption of patient ventilation.To date, there have been no reports of permanent patient injury as a result of this issue. no reports of disconnect have been received from australian facilities to date.
  • Action
    Halyard is advising: - Before using the Flex Connector, evaluate its connection to the Swivel Connector of the Closed Suction adapter to ensure an adequate connection. Evaluation of the connection can be accomplished by pushing the Flex Connector onto the Swivel Connector. Users should refer to the images provided on the Customer Letter to establish whether an adequate connection has been obtained. - If a disconnection between the Flex Connector and Swivel Connector is observed during use, replace the Flex Connector with a new, sterile Flex Connector and ensure adequate connection

Device

Halyard Closed Suction Kits with Flex Connector
  • Modèle / numéro de série
    Halyard Closed Suction Kits with Flex Connector Multiple Product TypesARTG Number: 259994(Halyard Australia - Catheter, suction, general-purpose)
  • Classification du dispositif
    Anesthesiology Devices
  • Manufacturer
    Halyard Australia Pty Ltd

Manufacturer

Halyard Australia Pty Ltd