Events

Level One fluid heaters 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 SMITHS MEDICAL 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
    2007-08-28
  • 사례 국가
    France
  • 사례 출처
    ANSM
  • 사례 출처 URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retraits-de-lots-de-tubulures-pour-rechauffeurs-de-fluides-level-one-series-h1000-smiths-medical
  • 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 27/08/07, the company SMITHS MEDICAL removed from the market batches whose expiry is less than or equal to July 2011 references D50-DI50; D60-DI60; D70; D100-DI100 and D300-DI300 medical device called Level One fluid heaters (series H1000) due to a leakage problem. Recommendations. were issued by the manufacturer (May 2007) to users, pending the marketing of new, more secure tubings, including a test procedure to detect any leakage to be made prior to their use. The recall follows the reporting of new incidents despite these recommendations and the availability of the new tubing. The company SMITHS MEDICAL directly notified the recipients of the incriminated lots with the message attached (28/08/2007) (451 ko) validated by Afssaps. This information is addressed to the directors and correspondents of materotovigilance for diffusion if necessary to the services concerned. The competent European authorities have been informed by the competent German authority.

Device

Level One fluid heaters
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    SMITHS MEDICAL

Manufacturer

SMITHS MEDICAL
  • Source
    LAANSM