Events

EASYPUMP LT 100-48;EASYPUMP LT 60-24 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 B.Braun Medical 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
    2008-08-22
  • 사례 국가
    France
  • 사례 출처
    ANSM
  • 사례 출처 URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/rappel-de-lots-de-systeme-de-perfusion-easypump-lt-100-48-et-lt-60-24-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
    On 20/08/2008, the company B.Braun Medical has withdrawn from the market the batches and references mentioned in the recall of the medical devices called: EASYPUMP LT 100-48 and EASYPUMP LT 60-24, the syringes are manufactured by B. Braun Melsungen AG, Switzerland and Easypump infusion sets by I-Flow Corporation in the USA. This withdrawal follows the discovery during a routine inspection of products from the production sample library. perforations of certain syringe packages that may compromise the sterility of the medical device. The company B.Braun medical has directly notified the recipients of the incriminated lots with the message attached (22/08/2008) (193 KB) validated by Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned.

Device

EASYPUMP LT 100-48;EASYPUMP LT 60-24
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    B.Braun Medical

Manufacturer

B.Braun Medical