Events

Infusor SV2 and syringe 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
    2009-03-10
  • 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-lot-infusor-sv2-et-seringue-baxter
  • 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 March 6, 2009, the company BAXTER withdrew from the market the 2008K21 batch of the reference 2C1702KD of the medical device called "Infusor SV2 and syringe" following an error on the refund sticker. The sticker corresponds, in fact, to the product "Intermate SV100" instead of "Infusor SV2". The product concerned, apart from the error on the sticker, complies with the product specifications. The BAXTER company has directly notified the distributors of the offending lot who will inform the recipients concerned with the enclosed message (10/03/2009) (30 KB) validated by Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. Given the small number of recipients, no alert number has been assigned to this withdrawal.

Device

Infusor SV2 and syringe
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    BAXTER

Manufacturer

BAXTER