Events

100cc silicone suction tanks with anti-reflux valv 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 Saint-Gobain Performance Plastics Francel 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
    2010-05-05
  • 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-reservoirs-de-succion-en-silicone-de-100cc-avec-valve-anti-reflux-saint-gobain-performance-plastics-france
  • 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 May 3, 2010, Saint-Gobain Performance Plastics Francel withdrew the lots from the market. 400409100. 40080910. 40060915. 400809202. 400109904. 400100931. 400809007 of the reference 3101-ASS 3101of the medical device called "100cc silicone suction tanks with anti-reflux valve", manufactured by SGPPL France, following a lack of sterility. The company Saint-Gobain Performance Plastics Francel directly notified the recipients of the incriminated lots with the enclosed message validated by Afssaps. (05/05/2010) (878 kb.) This information is intended for the directors and correspondents of materiovigilance for dissemination, where appropriate, to the departments concerned, the relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

100cc silicone suction tanks with anti-reflux valv

Manufacturer

Saint-Gobain Performance Plastics Francel