SteriPan saline and steril spray nasal 100 ml 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 La Brosse and Dupont 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
    2013-04-30
  • 사례 국가
  • 사례 출처
    ANSM
  • 사례 출처 URL
  • 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
    At the request of the ANSM, the manufacturer LBD (La Brosse and Dupont) proceeds, as a precautionary measure, to the recall, to their places of distribution, of certain batches of the medical devices listed below. This recall follows the detection of regulatory nonconformities in the manufacture of these medical devices that can not guarantee the quality of these products. The products concerned by this recall are. STERIPAN Physiological saline 30 single-dose / 5 ml - lot 34162. STERIPAN nasal spray 100 ml - all packs. These products are sold exclusively in the retail networks. Read auss. Decision of 22/04/2013 suspending the manufacture, placing on the market, export and distribution of medical devices, listed in the appendix, placed on the market by the company GIFRER BARBEZAT and the company LBD and withdrawing certain lots of these products (24/04/2013) (363 KB) Manufacturer's information letter (30/04/2013) (71 KB)

Device

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

Manufacturer

  • Source
    LAANSM