Events

Rappel de Catheters for expanding angioplasty

Selon Korean Food & Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à South Korea qui a été fabriqué par Biotronic Korea 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
    735
  • Date
    2017-11-07
  • Pays de l'événement
    South Korea
  • Source de l'événement
    KFDA
  • URL de la source de l'événement
    https://emed.mfds.go.kr
  • Notes / Alertes
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, 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 South Korea.
  • Notes supplémentaires dans les données
    No. 16-389

Device

Catheters for expanding angioplasty

Manufacturer

Biotronic Korea Co., Ltd.
  • Adresse du fabricant
    344 Pangyo-ro, Bundang-gu, Seongnam-si, Gyeonggi-do
  • Commentaire du fabricant
    Biotronik told ICIJ that, when it identifies the need to issue a recall, the company immediately informs physicians of all potentially affected patients. It also noted that product recalls for all manufactures are publically available on the relevant national authorities’ websites. “As soon as an event is deemed serious either by a hospital or a manufacturer, it is reported inter alia to the regulatory authority in the country in which the incidence has occurred, as well as to the FDA for US-approved devices, even if the event has occurred outside of the US,” the company said.
  • Source
    KFDA