Events

Hemodialysis accessories reference S660C and C330 from the company GAMBRO 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 GAMBRO 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
    2003-02-10
  • 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-accessoires-pour-hemodialyse-reference-s660c-et-c330-de-la-societe-gambro
  • 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
    GAMBRO withdraws from the market batches 0241-40 and 0238-40 of the reference S660C (product code 6431233A) and batches 0239-40, 0242-40 and 0245-40 of the reference C330 (product code 6430086) of the medical devices called hemodialysis accessories due to a high rate of nonconformities, ie cracks or breaks in the female luer lock connector that can lead to leakage during use (the cases reported to date have not had any serious consequences Patients) .. The S660C is a dialysis accessory that allows the connection between the blood line and the fistula needle or catheter to perform a single needle treatment.The C330 is an extension line for recirculation of the priming solution in the blood lines.

Device

Hemodialysis accessories reference S660C and C330 from the company GAMBRO
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    GAMBRO

Manufacturer

GAMBRO
  • Source
    LAANSM