Events

FLOVAL SE Flowmeters 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 Air Liquide Santé France 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
    2008-03-04
  • 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-debitmetres-a-bille-floval-se-societe-flow-meter-s-p-a
  • 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 29/02/08, Air Liquide Santé France withdrew from the market all the batches of the references cited in the attached message (29/02/2008) (23 KB) of the medical device called Ball Flowmeters " FLOVAL SE ", manufactured by Flow Meter, following a manufacturing defect highlighted on the notched fittings manufactured between 2005 and 2007 which may be at the tolerance limit set by the AFNOR NF S 90-116 standard. Air Liquide Santé France has directly notified the recipients of the offending batches by means of the enclosed message validated by Afssaps. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

FLOVAL SE Flowmeters

Manufacturer

Air Liquide Santé France