Events

Y connector (dialysis accessory) 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 Gambro Hospal 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
    2010-10-25
  • 사례 국가
    France
  • 사례 출처
    ANSM
  • 사례 출처 URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/connecteur-y-accessoire-de-dialyse-gambro-hospal-retrait-de-lots
  • 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
    On October 21, 2010, the company Gambro Hospal removed from the market batches 1035 and 1037 of the reference 6431233 of the medical device called "dialysis accessory: connector YS 660 C", manufactured by Gambro Dasco, following the highlighting internally the possible presence of a micro-hole at the female luer fitting that could possibly result in the penetration of air into the blood. No reports have been reported to date. The company GAMBRO HOSPAL directly warned the recipients of the incriminated lots with the message attached (25/10/2010) (1319 kb) validated by Afssaps. This information is intended for directors and correspondents of materiovigilance for dissemination where appropriate to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

Y connector (dialysis accessory)
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    Gambro Hospal

Manufacturer

Gambro Hospal