Events

ORBITER ST electrodes;STINGER 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 BARD France 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
    2003-02-04
  • 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-d-electrodes-orbiter-st-et-stinger-a-l-initiative-de-la-societe-bard-france
  • 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 Agency was informed on 17 January 03 of the following withdrawal. BARD France has withdrawn from the market on January 13, 03 all batches of references 210001 to 210030, 210001M to 210030M, 210001S to 210030S, 210001SM to 210030SM, 320001 to 320009, 320100 of the medical device referred to as ORBITER ST electrodes and STINGER following a risk of tearing the TYVEK side of the bag .. These devices are electrophysiological electrodes for ablation and mapping .. Given the small number of recipients, the company BARD warned them directly.

Device

ORBITER ST electrodes;STINGER
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    BARD France

Manufacturer

BARD France