Events

Easypump Portable Diffuser 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 I-Flow Corporation 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
    2006-01-30
  • 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-diffuseur-portable-easypump-distribue-par-b-braun-medical
  • 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
    B.Braun Medical withdraws from the market, at the request of the manufacturer I-Flow Corporation, the references and batches specified below, of the medical device known as "Easypump" following a report of a batch and reference error on the primary packaging. The references and lots concerned are:. Easypump ST 100-1 (box of 10) reference 4434350 lot 56279. Easypump LT 60-24 (box of 1) reference 4434367 lot 56285. The company has directly notified the recipients concerned with the enclosed message (30 / 01/2006) (25 kb) validated by Afssaps. This information is addressed to the directors of health establishments and the local correspondents of materiovigilance for diffusion, if necessary with the services concerned .. This reminder concerns only the La France.

Device

Easypump Portable Diffuser
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    I-Flow Corporation

Manufacturer

I-Flow Corporation
  • Source
    LAANSM