Events

HEMARCOL 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 DENTSPLY 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
    2003-01-08
  • 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-du-dispositif-hemarcol-de-la-societe-dentsply-france
  • 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
    Following the decision of the Director-General of the Agency dated 26 December 2002, suspending wholesale distribution, the placing on the French market for whatever reason, the export, the holding for sale, the the distribution or disposal and use of certain lots of the HEMARCOL device, the company DENTSPLY France withdraws lots 1004, 1003, 1002, 1001, 0002, 0001 from this device. This is a measure precautionary due to the lack of data (traceability of animals) concerning the bovine gelatin used in the composition of this device. These sponges are used by dentists in hemostatic compression after tooth extraction. No number has been assigned to this alert, the company DENTSPLY directly notifying the users concerned.

Device

HEMARCOL
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    DENTSPLY

Manufacturer

DENTSPLY
  • Source
    LAANSM