Events

Rappel de Ambu Laryngeal Mask, single-use

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Ambu AS.

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
    19585
  • Date de mise en oeuvre de l'événement
    2015-12-18
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Medxus Ltd, Unit 4, 100 Fitgerald Avenue, Christchurch 8011
  • Cause
    Potential sterility breach., a failure has been discovered during routine quality control at the manufacturing site., this failure may cause a small hole, (approximately 0.5mm) in the pouch of the device leading to a potential compromised sterile barrier., after identification of failure, comprehensive investigation has shown a low prevalence of up to 3% for the affected lots., manufacturer has not received any complaints or other market feedback on the matter, dating from when the products were marketed in 2014., .

Device

Ambu Laryngeal Mask, single-use
  • Modèle / numéro de série
    Model: AMB408-300-000, Affected: 1794260, 1745425, 1724948, 1794260, 1729556, 1724950, 1732622
  • Manufacturer
    Ambu AS

Manufacturer

Ambu AS
  • Société-mère du fabricant (2017)
    Ambu A/S
  • Source
    NZMMDSA