DUOFLO 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 BAXTER 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
    2002-03-20
  • 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
    The BAXTER company withdraws from the market lot 05290106 the topical / surgical manual vaporizer medical device reference B2232000999999 following a signal of detachment of the spray nozzle of this device during its use and the potential risk for the patient in case this separation occur during a surgical procedure, since the spray tip is not radiopaque. This device is used for the application of fibrin glue .. Description of the incident: risk of detachment of the spray tip of this device during its use .. Consequences or risk: risk of loss of the tip at the level of the wound because it is not radiopaque .. Given the reduced number of recipients of this lot, they were warned directly by the laboratory .. Therefore, no alert number n 'has attributed to this withdrawal.

Device

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

Manufacturer