Events

SHILEY TRACHEOSOFT XLT 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 TYCO Healthcare 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
    2004-07-19
  • 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-canules-de-tracheotomie-xlt-de-la-societe-tyco-healthcare
  • 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, TYCO Healthcare withdraws from the market all batches of the references specified in the appendix of the medical device known as SHILEY TRACHEOSOFT XLT long and flexible tracheostomy tubes due to a risk of separation between the cannula and the fitting, which may lead to a migration of the cannula in the airways .. No incident has been recorded so far, in France. The health facilities concerned by this recall are notified directly by the company TYCO Healthcare by means of the message attached (19/07/2004) (20 KB). The recall concerns only the XLT models and does not concern the tracheostomy tubes of the SHILEY type and of the TRACHEOSOFT type of the same company.

Device

SHILEY TRACHEOSOFT XLT

Manufacturer

TYCO Healthcare
  • Source
    LAANSM