Events

ALTHANE A-18 dialysis machines 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
    2001-09-01
  • 사례 국가
    France
  • 사례 출처
    ANSM
  • 사례 출처 URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/suspension-d-utilisation-et-rappel-de-tous-les-dialyseurs-althane-a-18
  • 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 September 1, 2001, Baxter sent a warning message to the physician in charge and / or pharmacist in charge of 9 hemodialysis centers in possession of ALTHANE A-18 dialysis machines, to inform them of the suspension of use and all batches of dialyzers ALTHANE A-18 are recalled. See also the press release of 01/09/0. . Alert message to the physician in charge and / or pharmacist in charge of the center (Copy to the materiovigilance correspondent). September 1, 2001. Subject: ALTHANE A-18 dialysis machine (code 237018. Dear Doctor, Our company has recalled in Spain on August 31, 2001 two batches of ALTHANE A-18 dialyzers, following the deaths of 10 people. recalled, are not marketed in France .. Although there is no evidence of a link between our dialyzers and the death of these patients, this action was initiated as a precautionary measure in the interest of the safety of patients. We have been informed that other possible causes unrelated to dialyzers are being evaluated in the Spanish centers that reported these events. "The analyzes conducted to date on A-18 dialysers revealed no anomaly .. Our traceability allowed us to identify that your center uses this type of ALTHANE A-18 dialyser. At the request of the Afssaps, we proceed to the recall of all ALTHANE A-18 dialyzer batches. in your possession will have to We will be returned as soon as possible. Our services will contact you to organize with you the conditions of recovery of these products. In addition, we ask that you immediately stop using these devices and inform the centers or patients to whom this device has been provided. For any additional information, a telephone number is at your disposal: 01 34 61 53 3. Please accept, Dear Doctor, the assurance of our highest consideration .. Nicole Denjo. Director, Global Vigilance. Baxter, Renal Therapy Division

Device

ALTHANE A-18 dialysis machines
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    Baxter

Manufacturer

Baxter
  • Source
    LAANSM