Events

ALN Cell Vein Filters 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 ALN Implants Chirurgiques 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
    2008-03-03
  • 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-filtres-veine-cave-aln-societe-aln-implants-chirurgicaux
  • 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    On 29/02/08, ALN Implants Chirurgiques has withdrawn lots 0107A - 0207A - 0207B - 0307A - 0407A from references FF.010995 - FJ.120096 - FB.010500 of the medical device called ALN Cell Vein Filters, manufactured by ALN Surgical Implants, following a nonconformity detected at the angle of the strands of attachment of the filter, this angle being greater than the angle validated by the manufacturer. The company ALN Implants Chirurgicaux has directly notified the recipients of the incriminated lots with the message attached (29/02/2008) (20 KB) validated by Afssaps. This information is intended for the directors, correspondents of materiovigilance and pharmacists for dissemination where appropriate to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

ALN Cell Vein Filters

Manufacturer

ALN Implants Chirurgiques
  • 제조사 모회사 (2017)
    A.L.N.
  • Source
    LAANSM