Events

Medtronic guide catheter 110 cm;Medtronic Guide Catheter 100 cm 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 Medtronic France SAS 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
    2006-04-14
  • 사례 국가
    France
  • 사례 출처
    ANSM
  • 사례 출처 URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lots-de-catheter-guide-medtronic
  • 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    The company Medtronic France SAS has withdrawn from the market on April 12, 2006, the references and lots, list (12/04/2006) (19 KB) is detailed in the appendix, medical devices called "Medtronic guide catheter 110 cm" and "Medtronic Guide Catheter 100 cm" packaged in 110 cm pockets. This decision follows the detection, during integrity tests, of a risk of micro-holes in the catheter packaging that could create a breach in the sterile barrier of the catheter. The company has directly notified the recipients of the offending lots by means of the attached message (12/04/2006) (17 KB) validated by Afssaps. The relevant European Competent Authorities are informed of this measure by the manufacturer. .. This information is addressed to the directors of health establishments and the local correspondents of materiovigilance for diffusion, if necessary to the services concerned.

Device

Medtronic guide catheter 110 cm;Medtronic Guide Catheter 100 cm
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    Medtronic France SAS

Manufacturer

Medtronic France SAS
  • Source
    LAANSM