Events

Rappel de Of Spiggle & Thesis PTFE Ventilation Tubes - Fluoroplastic shepard button and Fluoroplastic collar button (Tympanostomy tubes used to ventilate the middle ear subsequent to otitis media)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par CoreMed 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-2013-RN-00888-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-08-20
  • 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-2013-RN-00888-1
  • 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
    The primary packaging of the affected products could potentially have damage to the seal or seam. the sterility of the articles concerned is not guaranteed. it may not be possible for the user to identify this fault with absolute certainty.
  • Action
    Customers are requested to quarantine the affected lots of product and organise with CoreMed for the return of any unused product.

Device

Of Spiggle & Thesis PTFE Ventilation Tubes - Fluoroplastic shepard button and Fluoroplastic colla...
  • Modèle / numéro de série
    Of Spiggle & Thesis PTFE Ventilation Tubes - Fluoroplastic shepard button and Fluoroplastic collar button (Tympanostomy tubes used to ventilate the middle ear subsequent to otitis media) Fluorplastic shepard button, 1.15mmRef.: 104115Lot numbers: 201208220750, 201210120800, 201211090450, 201302261000, 201301091000 and 201304121000Fluoroplastic collar button, 1.25mmRef.: 104125Lot number: 201301080700, 201302260700, A01210190500 and 201208130480ARTG Number: 182921
  • Manufacturer
    CoreMed Pty Ltd

Manufacturer

CoreMed Pty Ltd