Events

Ercelab Vermed Company 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 Ercelab Vermed, Moria and Odon Life Technology 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
    2003-03-04
  • 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-dispositifs-medicaux-des-societes-ercelab-vermed-moria-et-odon-life-technology
  • 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 as a precaution, the companies Ercelab Vermed, Moria and Odon Life Technology withdraw from the market the medical devices listed below following a doubt concerning the interpretation of the results of one of the biological indicators placed in the sterilization cycle carried out by a common subcontractor. Ercelab Vermed Company. valve extensions reference 85016 lot 44463A This device is used when performing urodynamic tests. . Moria company:. . microkeratome rings and heads reference 19321/130 batch DISP-1 00. aspiration tubes for microkeratomes reference 19138 lot TUELSK 05. slides for microkeratome M2 reference 19329 batches LAM M2F 037 and 038.. Odon Life Technology Company. polypectomy loops reference 02APO3001 lot 02472 and references 02APO4001 lots 02474 and 02475.. Recipients have been informed directly by the manufacturers

Device

Ercelab Vermed Company

Manufacturer

Ercelab Vermed, Moria and Odon Life Technology
  • Source
    LAANSM