Events

Rappel de Teleflex Medical RTP - Valve, non-rebreathing

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 Teleflex Medical 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
    22833
  • Date de mise en oeuvre de l'événement
    2018-04-19
  • 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: Teleflex Medical New Zealand, 12 Victoria Street, Private Bag 31346, Lower Hutt, Wellington 5040
  • Cause
    The manufacturer has indentified that the hudson rci one-way valve with capped may disconnect at the joint between the two components that make up the device, which would cause an interruption of ventilation to the patient. disconnection of the valve is recognizable by the user as an alarm from the ventilator, oxygen sensor or other compatible device to which the valve is connected. however, disconnection of the valve in ventilator dependent patients without prompt response could lead to hypoxia, organ failure, or death.
  • Action
    Product to be returned to supplier

Device

Teleflex Medical RTP - Valve, non-rebreathing
  • Modèle / numéro de série
    Model: , Affected: Affected lot numbers 74D1501706, 74K1502092, 74F1600367, 74J1600117, 74L1601916, 74C1701733, 74F1700707, 74D1501731, 74K1502045, 74F1601072, 74J1601101, 74M1600284, 74C1702365, 74F1701866
  • Manufacturer
    Teleflex Medical Inc

Manufacturer

Teleflex Medical Inc