Events

Device Recall Asahi APS Series Dialyzers 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Asahi Medical Co Ltd 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
  • 사례 ID
    28341
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0739-04
  • 사례 시작날짜
    2001-10-01
  • 사례 출판 날짜
    2004-07-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2004-03-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31622
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Dialyzer, High Permeability With Or Without Sealed Dialysate System - Product Code KDI
  • 원인
    Customer reprocessing methods for the reuseable hollow fiber dialyzers may damage the hollow fibers and result in blood leaks during dialysis.
  • 조치
    Asahi visited each of the U.S. customers starting on 10/1/01, observing how the facility handles the dialyzer before pre-cleaning, during pre-cleaning and priming. The users were retrained in the reprocessing steps, emphasizing the controls and care to be taken during pre-cleaning, including the verification of water pressure.

Device

Device Recall Asahi APS Series Dialyzers
  • 모델명 / 제조번호(시리얼번호)
    Model Nos. APS-400S, APS-550S, APS-650S, APS-750S, APS-900S, APS-1050S. The recall is no lot specific.
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    New Jersey, Ohio, Texas, California, Georgia, Pennsylvania, Illinois and Indiana
  • 제품 설명
    Asahi APS Series Dialyzers, Model Nos. APS-400S, APS-550S, APS-650S, APS-750S, APS-900S, APS-1050S; the dialyzers are intended for single or initial use and under reprocessing and reuse conditions fo rup to 15 reuse cycles; Manufacturer: Asahi Medical Co., Ltd., 9-1, Kanda Mitoshirocho, Chiyoda-ku, Tokyo 101-8482, Japan; Distributed in teh USA by Nextron Medical, 45 Kulick Road, Fairfield, NJ 07004 USA
  • Manufacturer
    Asahi Medical Co Ltd

Manufacturer

Asahi Medical Co Ltd
  • 제조사 주소
    Asahi Medical Co Ltd, 1-1 Uchiauwaicho,1-Chome, 14 Flr, Imperial Tower Bldg, Chiyoda Ku Japan
  • Source
    USFDA