Events

Delivery Tubing for 6060 / Baxter Infusion Pump 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 BAXTER 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
    2004-12-06
  • 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-tubulures-d-administration-pour-pompe-de-perfusion-6060-baxter
  • 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    The company Baxter has withdrawn from the market on December 3, 2004, the references and batches specified in the appendix, the medical device called "infusion pump administration tubing 6060 with Autoclamp device" following the risk of free flow related to the absence of a cylindrical piece on the cassette, which prevents the pump from clogging the tubing and may result in drug overdose. No case has been reported in Europe .. The company has directly notified the recipients of references and offending batches using the message attached (03/12/2004) (29 KB) validated by Afssaps. This information is addressed to the directors of establishments, pharmacists and local correspondents of materiovigilance for dissemination, where appropriate to the departments concerned .. The relevant European Competent Authorities are informed of this measure by the manufacturer. References and offending lots (03/12/2004) (29 ko)

Device

Delivery Tubing for 6060 / Baxter Infusion Pump
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    BAXTER

Manufacturer

BAXTER