Events

Unshielded Biliary Endoprostheses (SHS) 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 LIFE PARTNERS EUROPE 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
    2009-12-04
  • 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-endoprotheses-biliaires-couvertes-shs-et-non-couvertes-shcl-par-life-parners-europe
  • 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 02/12/09, LIFE PARTNERS EUROPE removed from the market the batches of the references (listed in the mail destined for these customers) of medical devices called "Unshielded Biliary Endoprostheses (SHS)" and "Biliary Endoprostheses Covered with Lasso". -Hanarostent (SHCL) "following a defect that may occur during the placement of prostheses. Concerning the SHS reference, this is a blockage of the introducer of the stent and concerning the reference SHCL, it is a poor deployment of the prostheses at the level of the flare which carries the lasso: the Silicone blanket and lasso remain agglomerated. The company LIFE PARTNERS EUROPE has directly notified the recipients of the offending lots with the message attached (04/12/2009) (109 KB) validated by Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer. Read also Additional information from 14/01/2010

Device

Unshielded Biliary Endoprostheses (SHS)
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    LIFE PARTNERS EUROPE

Manufacturer

LIFE PARTNERS EUROPE