Events

Rappel de Arrow International - VPS Rhythm T-Piece

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 Arrow International 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
    22938
  • Date de mise en oeuvre de l'événement
    2018-06-29
  • 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 become aware that some individual units may have defective packaging that may not be adequately sealed. in the event the packaging is compromised in this manner, the sterility of the product cannot be guaranteed. if a non-sterile product is used, there is potential for infection to occur., update phase ii, the lubricant is being distributed to heartware field representatives who will apply the lubricant to power source (battery, ac adapter, and dc adapter) connecters. the heartware field representatives will work with healthcare professionals to coordinate bringing patients to the clinic for servicing of their hvad power source components.
  • Action
    Product to be destroyed

Device

Arrow International - VPS Rhythm T-Piece

Manufacturer

Arrow International Inc