Events

Rappel de Rusch Bronchopart Tube Set Left

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 Rusch Inc.

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
    17809
  • Date de mise en oeuvre de l'événement
    2015-01-12
  • 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: Ebos Group Ltd, 14-18 Lovell Court, Rosedale, Auckland 0632
  • Cause
    Teleflex are recalling specific products following receipt of customer complaints reporting that the cobb connector detached from the main connector prior to use. this cobb connector detachment should be readily identified by the user during set-up and prior to use of the device. if during use, cobb connector separation occurs and presents as a leak in the breathing circuit and if it is unnoticed, then there is a remote probability that the patient may need to be re-intubated due to the risk of respiratory distress and hypoxia.
  • Action
    Product to be returned to supplier

Device

Rusch Bronchopart Tube Set Left
  • Modèle / numéro de série
    Model: Product Code: 116100-000260, Affected: 29 lots
  • Manufacturer
    Rusch Inc

Manufacturer

Rusch Inc