Events

Rappel de Tracoe Twist Tracheostomy TubeSize 06

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-01321-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-10-20
  • 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-01321-1
  • 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
    Tracoe medical has established at primary packaging, that some obturators of one batch (size 06) can break when inserted into the outer cannula. this may result in the breakage of the obturator whilst in the patient within the tube. if this was to occur, the broken fragments would likely be inhaled into the lower respiratory tract.In the event the breakage of the obturator is not detected, the aspirated fragments may remain in the deep respiratory tract. should the fragments remain there over a longer period of time, in the worst case scenario, an inflammatory reaction in the respiratory tract can occur.
  • Action
    Intersurgical is advising users to quarantine affected stock. Intersurgical will collect stock from affected customers and provide credit.

Device

Tracoe Twist Tracheostomy TubeSize 06
  • Modèle / numéro de série
    Tracoe Twist Tracheostomy TubeSize 06Reference Number: REF 306-06Batch Numbers: 1000123766, 1000124104, and 1000124346 ARTG Number 128498 (Intersurgical Australia Pty Ltd - Tube, tracheostomy, single use)
  • Manufacturer
    Intersurgical Australia Pty Ltd

Manufacturer

Intersurgical Australia Pty Ltd