Events

CYTOSOL saline solution 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
    2006-03-08
  • 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-solution-saline-cytosol-distribuee-par-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
    At the request of the manufacturer CYTOSOL Laboratories Inc., the company BECTON DICKINSON, distributor for France, withdraws from the market all batches of the medical device called "CYTOSOL saline solution 18 ml" and "BD Custom Eyes kit" references 581758 and 588100 following two cases of toxic syndrome reported in the USA related to the presence of endotoxins. The company has directly notified the recipients concerned with the message attached (08/03/2006) (20 KB) validated by Afssaps .. This information is addressed to the directors of health establishments, pharmacists and local correspondents of materiovigilance for dissemination, where appropriate to the ophthalmology and ophthalmic surgery departments. The relevant European Competent Authorities are informed of this measure. by the distributor.

Device

CYTOSOL saline solution
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    BECTON DICKINSON

Manufacturer

BECTON DICKINSON