Events

Rappel de Parker Medical Flex-Tip endotracheal tube

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 Well Lead Medical Co 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
    13568
  • Date de mise en oeuvre de l'événement
    2012-10-03
  • 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: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
  • Cause
    Several reports that the cuffs of parker medical tubes with the lot number 1107021643 lacked the ability to be properly inflated or to maintain pressure after inflation. there are no reports of patient injury. parker medical is concerned with the potential for injury due to the inability of the cuffs on these tubes to be properly inflated or to maintain their pressure after inflation.
  • Action
    Product to be returned to supplier

Device

Parker Medical Flex-Tip endotracheal tube
  • Modèle / numéro de série
    Model: Lot No; 1107071643, Affected: I-PFHV -70, I-PFHV-75 and I-PFHV-80
  • Manufacturer
    Well Lead Medical Co Ltd

Manufacturer

Well Lead Medical Co Ltd