Events

Spacer® INHALATION DEVICES INHALATION DEVICES 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 AstraZeneca 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
    2009-04-06
  • 사례 국가
    France
  • 사례 출처
    ANSM
  • 사례 출처 URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/rappel-de-tous-les-lots-du-dispositif-pour-inhalation-chambre-nes-spacer-r-references-acl-726-521-0-acl-726-522-7-acl-726-523-3
  • 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
    AstraZeneca, in agreement with Afssaps, is recalling all batches of the Spacer® INHALATION DEVICES INHALATION DEVICES (References: ACL 726 521.0, ACL 726 522.7, ACL 726 523.3) as a result of a risk of incorrect assembly of this device .. Indeed, it is important that the mouthpiece is connected to the chamber in the right direction because it has a unidirectional valve. However, AstraZeneca has received reports that it has been possible to insert the mouthpiece in the wrong direction, sometimes with significant clinical consequences. AstraZeneca will not be able to replenish pharmacies with new Nes Spacer® rooms. A letter is sent to doctors and pharmacists about alternative measures to take. Regarding the return of products in your possession, you are requested to complete the attached form and fax it back to the number specified on this form, so that our team can contact you as soon as possible. For any information, please contact 01 41 29 43 7. This information is intended for pharmacists, doctors, correspondents of materiovigilance for distribution where appropriate to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer. Read auss. Mail sent to pharmacists (06/04/2009) (23 KB Mail addressed to doctors (06/04/2009) (23 kB Return modality form (06/04/2009) (22 KB) Communiqué of 06 / 04/2009

Device

Spacer® INHALATION DEVICES INHALATION DEVICES
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    AstraZeneca

Manufacturer

AstraZeneca