Events

MEDISET 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 Laboratories Paul Hartmannn 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
    2010-03-16
  • 사례 국가
    France
  • 사례 출처
    ANSM
  • 사례 출처 URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/rappel-de-lots-d-un-dispositif-medical-mediset-trousse-de-soins-pour-ablation-de-fils-par-le-laboratoire-paul-hartmann
  • 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 15/03/2010, Laboratories Paul Hartmannn removed from the market batches 900701137 and 900801134 of the reference 470119/6 of the medical device called "MEDISET - Kit of care for ablation of threads" following the highlighting of a defect of the wire cutters present in these kits. The black plastic part around the axis of rotation is likely to break when using the scissors. The laboratories Paul Hartmann directly warned the recipients of the incriminated lots with the message attached (16/03/2010) (29 KB) validated by Afssaps. This information is addressed to 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

MEDISET

Manufacturer

Laboratories Paul Hartmannn
  • Source
    LAANSM