Events

Rappel de Spiggle & Theis ENT sinus single-use suction tubes (used for paranasal sinus suction)

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-2016-RN-00184-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-02-19
  • 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-2016-RN-00184-1
  • 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 a chance that the connection between the tube and the tip is faulty. this can lead to the tip loosening during use. the resulting risk for the patient, is that the tip could be left behind in the treated area or could be inhaled, which may lead to a severe health impairment for the patient. to date we are not aware of such a case.
  • Action
    CoreMed is advising users to quarantine any remaining stocks of the affected product and return for replacement with unaffected stock.

Device

Spiggle & Theis ENT sinus single-use suction tubes (used for paranasal sinus suction)
  • Modèle / numéro de série
    Spiggle & Theis ENT sinus single-use suction tubes (used for paranasal sinus suction)Disposable suction tubes, 100mm length, sinus/nasal, 3.0mm dia, 45°angle, box of 50 (9fr)Product Code: REF 3010030Lot Number: 014443Disposable suction tubes, 100mm length, sinus/nasal, 4.0mm dia, 45°angle, box of 50 (12fr)Product Code: REF 3010040Lot Number: 014645, 014832ARTG Number: 205220
  • Manufacturer
    CoreMed Pty Ltd

Manufacturer

CoreMed Pty Ltd