Events

Rappel de Solus Flexible, wire-reinforced laryngeal mask airway Small paediatric, wire-reinforced laryngeal mask airway 2 Large paediatric, wire-reinforced laryngeal mask airway 2.5 Small adult, wire-reinforced laryngeal mask airway 3 Medium adult, wire-reinforced laryngeal mask airway 4 Large adult, wire-reinforced laryngeal mask airway

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Intersurgical 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-2017-RN-00447-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-04-05
  • 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-2017-RN-00447-1
  • 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 internal assessment by intersurgical of product performance, including a review of customer complaints, has confirmed that specific solus flexible wire-reinforced laryngeal mask airway products have a manufacturing fault in the tube. this fault can result in partial or total occlusion of the airway tube when the cuff is inflated, which may result in partial or total restriction of air delivery to and/or from the patient.
  • Action
    Intersurgical is advising users to inspect their stocks and quarantine all units from the affected lot numbers, and to destroy these affected products. Credit will be arranged for this stock.

Device

Solus Flexible, wire-reinforced laryngeal mask airway Small paediatric, wire-reinforced laryngeal...
  • Modèle / numéro de série
    Solus Flexible, wire-reinforced laryngeal mask airwaySmall paediatric, wire-reinforced laryngeal mask airway 2Large paediatric, wire-reinforced laryngeal mask airway 2.5Small adult, wire-reinforced laryngeal mask airway 3Medium adult, wire-reinforced laryngeal mask airway 4Large adult, wire-reinforced laryngeal mask airway 5Order Codes: 8002001, 8025001, 8003001, 8004001, 8005001Lot Numbers: from 31310354 to 31700331ARTG Number: 224554
  • Classification du dispositif
    Anesthesiology Devices
  • Manufacturer
    Intersurgical Australia Pty Ltd

Manufacturer

Intersurgical Australia Pty Ltd