Events

PRORHINEL Spray, nasal solution under pressure 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 NOVARTIS 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
    2005-03-25
  • 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-prorhinel-spray-solution-nasale-de-novartis-sante-familiale2
  • 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
    In agreement with Afssaps, the NOVARTIS Santé Familiale laboratory withdraws from the market the lots 2002 074 to 2002 089 included and 2003 091 to 2003 115 inclusive of the medical device called PRORHINEL Spray, nasal solution under pressure, following the report of a case of detachment of the end of the diffuser and its housing in the nostril of the patient. This recall only concerns France. The recipients concerned by this recall are the pharmacists who are notified through wholesaler-dispatchers. For information, pharmacists in health facilities are informed by the system of fax alerts.

Device

PRORHINEL Spray, nasal solution under pressure
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    NOVARTIS

Manufacturer

NOVARTIS
  • Source
    LAANSM