Events

MICRO CHIR PROVENCE 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 KRATZ 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
    2003-10-14
  • 사례 국가
    France
  • 사례 출처
    ANSM
  • 사례 출처 URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/suspension-de-commercialisation-de-certains-dispositifs-medicaux-mis-sur-le-marche-par-mcp
  • 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
    The manufacture, operation, export, wholesale distribution, placing on the market for free or for a fee, the holding for sale or the free distribution of sterile medical devices called "KRATZ blepharostats" and "infusion cannulas" used in ophthalmic surgery, manufactured and placed on the market by the company "MICRO CHIR PROVENCE", known as MCP, are suspended until they are brought into compliance with the laws and regulations in force. Decision of the Director General of Afssaps (14/08/2003) (73 KB) This decision took effect as of 12 September 2003, date of its publication in the French Official Journal. subject to withdrawal by the company "MCP" and its customers have been warned.

Device

MICRO CHIR PROVENCE
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    KRATZ

Manufacturer

KRATZ
  • Source
    LAANSM