Events

Rappel de Promed High Concentration Oxygen Masks, Elongated (under chin), Adult Med Concentration

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-2017-RN-00755-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-06-26
  • 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-00755-1
  • 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
    Convatec has received multiple reports of tubing detaching from the oxygen masks either prior to use (in the packaging) or during use. the detachment of the tubing would result in loss of oxygen to the patient. an investigation determined the failure was caused by an improper solvent bond between the oxygen tubing and the oxygen mask connector.
  • Action
    Thermo Fisher is advising users to inspect their stocks and quarantine all units from the affected batch numbers. Thermo Fisher will arrange for stock to be recovered and replacement stock, or a credit note, to be issued.

Device

Promed High Concentration Oxygen Masks, Elongated (under chin), Adult Med Concentration
  • Modèle / numéro de série
    Promed High Concentration Oxygen Masks, Elongated (under chin), Adult Med ConcentrationCatalogue Numbers: PMD06001, PMD06002, PMD06003, PMD06009 and PMD06106Lot Numbers: 100914, 100551, 100550, 100574 and 100581ARTG Number: 216605
  • Manufacturer
    Thermo Fisher Scientific Australia Pty Ltd

Manufacturer

Thermo Fisher Scientific Australia Pty Ltd