Events

Central venous catheters BD Hydrocath, BD Careflow, Seldy DB Seldy and kits of percutaneous introduction BD Exacta 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 BECTON DICKINSON 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
    2003-09-01
  • 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-veineux-centraux-de-la-societe-becton-dickinson
  • 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 BECTON DICKINSON withdraws from the market the references and the batches (specified in the appendix (01/09/2003) (13 ko)) of medical devices called central venous catheters BD Hydrocath, BD Careflow, Seldy DB Seldy and kits of percutaneous introduction BD Exacta following an increase in worldwide materiovigilance reports, reporting cases of partial disruption of the J-introduction guides provided with these catheters or in the percutaneous introducer kit. These devices are used in particular in the departments of anesthesia and resuscitation, intensive care and cardiology). The recipients concerned are notified directly by the manufacturer or distributor of these devices. For more details, attached the message (01/09/2003) (1 kb) sent by the company BECTON DICKINSON to users.

Device

Central venous catheters BD Hydrocath, BD Careflow, Seldy DB Seldy and kits of percutaneous intro...
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    BECTON DICKINSON

Manufacturer

BECTON DICKINSON