Events

Rappel de Opti-Mist Nebuliser / Nebuliser Mask ProductsOpti-Mist Nebuliser Kit 210cm Tmouth 50Opti-Mist + Nebuliser 210cm T/Mouth10/50Opti-Mist + Nebuliser 210cm admask 10/50Opti-Mist + Nebuliser Ped Kit (5X10) Opti-Mist + CS Fits-A 210cm(10/20)Opti-Mist Plus Nebuliser Only (10/50) Opti-Mist CL Nebuliser Kit (50)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Thermo Fisher Scientific 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-2015-RN-01184-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-12-03
  • 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-2015-RN-01184-1
  • 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
    Specific batches of nebuliser mask products are not meeting specification. an error in the manufacturing of a component (jet orifice) resulted in this component being unable to produce atomisation or misting of supplied medication, saline or water contained in the nebuliser unit. no or poor misting would impact the delivery of aerosolised liquids to the patient, which has the potential to result in harm if used with this defect.
  • Action
    Thermo Fisher is advising users to inspect and quarantine any affected stock for return to Thermo Fisher. This action has been closed-out on 26/08/2016.

Device

Opti-Mist Nebuliser / Nebuliser Mask ProductsOpti-Mist Nebuliser Kit 210cm Tmouth 50Opti-Mist + N...
  • Modèle / numéro de série
    Opti-Mist Nebuliser / Nebuliser Mask ProductsOpti-Mist Nebuliser Kit 210cm Tmouth 50Opti-Mist + Nebuliser 210cm T/Mouth10/50Opti-Mist + Nebuliser 210cm admask 10/50Opti-Mist + Nebuliser Ped Kit (5X10) Opti-Mist + CS Fits-A 210cm(10/20)Opti-Mist Plus Nebuliser Only (10/50) Opti-Mist CL Nebuliser Kit (50)Product Codes: PMD02600, PMD02601, PMD02602, PMD02603, PMD02604, PMD02605, PMD02606Multiple Lot NumbersARTG Number: 214820
  • Manufacturer
    Thermo Fisher Scientific Australia Pty Ltd

Manufacturer

Thermo Fisher Scientific Australia Pty Ltd