Events

PTCA catheter batches 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 CORDIS 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
    2004-07-16
  • 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-catheters-de-ptca-de-la-societe-cordis
  • 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
    In agreement with Afssaps, CORDIS withdraws from the market the references and batches specified in the attached list (16/07/2004) (44 KB) of the medical device known as "dilatation catheters for percutaneous transluminal coronary angioplasty (PTCA)". AQUA T3 "following the identification of certain catheters that do not have a sufficient internal coating on the body of the extruded tubing, which may cause difficulties during the procedure, such as difficulty in removing the stylet, moving the guide or loosening pressure. No reports have been reported in France to date. The health facilities concerned by this recall are notified directly by CORDIS SAS by means of the attached message (16/07/2004) (40 KB).

Device

PTCA catheter batches
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    CORDIS

Manufacturer

CORDIS