Events

KRATZ blepharostat and infusion cannulas from MCP 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 Micro Chir Provence (MCP) 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
    2003-06-27
  • 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-blepharostat-de-kratz-et-de-canules-d-infusion-de-la-societe-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
    At the request of the Agency and following an inspection, the company Micro Chir Provence (MCP), withdraws from the market:. batch B30108 of the reference B31050 of the medical device called blepharostat of KRAT. batches B30201 and B30105 of reference B41060 - infusion cannulas. lot B30106 of reference B41061- infusion cannulas. batch B30107 of the reference B41064 - infusion cannulas following the absence of an EC certificate of conformity and the absence of validation of the sterilization. These devices are used in cataract surgery. These devices are distributed by PRODIS, which will directly inform the 4 users of these batches (France).

Device

KRATZ blepharostat and infusion cannulas from MCP

Manufacturer

Micro Chir Provence (MCP)
  • Source
    LAANSM