Events

AV Set FMC dialysis lines 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 Fresenius Medical Care 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
    2004-10-18
  • 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-de-ligne-de-dialyse-de-la-societe-fresenius-medical-care
  • 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 October 15, 2004, the company Fresenius Medical Care withdrew from the market several batches of references 5017531 and 5017851 of the medical device called AV Set FMC dialysis lines following several reports of blood leakage in the arterial chamber. health concerned by this recall are warned directly by means of the message attached (18/10/2004) (13 KB) validated by Afssaps. This information is addressed to the local correspondents of materiovigilance and to the directors for diffusion to the concerned services. The other European competent authorities have not been informed, this measure only concerning France .. Courrier Fresenius Medical Care (18/10 / 2004) (13 KB)

Device

AV Set FMC dialysis lines

Manufacturer

Fresenius Medical Care