Events

HANAROSTENT Biliary Stent 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 MITech Co., Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 날짜
    2008-04-25
  • 사례 국가
    France
  • 사례 출처
    ANSM
  • 사례 출처 URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lots-du-dispositif-stent-biliaire-hanarostent-avec-introducteur-de-diametre-7-f-societe-life-partners-europe
  • 비고 / 경고
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • 데이터 추가 비고
  • 조치
    On 24/04/08, Life Partners Europe has withdrawn from the market the batches of the references contained in the enclosed message of the medical device known as HANAROSTENT Biliary Stent with Introducer of 7 F diameter manufactured by MITech Co., Ltd., following two incidents in Asia in which the external catheter broke off the introducer during the procedure. Such an incident is patient-free because it appears in the 1st stage of the procedure, before implantation of the prosthesis when the device can be totally removed from the endoscope. Life Partners Europe has directly notified the recipients of the offending lots by means of the attached message (25/04/2008) (37 KB) validated by Afssaps. This information is addressed to the directors, correspondents of materiovigilance and pharmacists for diffusion if necessary to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

HANAROSTENT Biliary Stent
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    MITech Co., Ltd

Manufacturer

MITech Co., Ltd
  • Source
    LAANSM