Events

Device Recall Transonic ADT 1018 Flow QC Clear Advantage Tubing 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Transonic Systems Inc 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
    79750
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1776-2018
  • 사례 시작날짜
    2018-02-15
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163235
  • 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
    Hemodialysis Catheter Luer End Cap - Product Code PEH
  • 원인
    The sterility of the device cannot be assured. there is a potential for an increased risk of infection.
  • 조치
    The recalling firm has sent all of its customers a Recall Notification Letter dated February 15, 2018, and has included a Customer Reponse Form that requests that customers either return or destroy the ADT1018 Tubing in their possession. For further questions, please call (800) 353-3569.

Device

Device Recall Transonic ADT 1018 Flow QC Clear Advantage Tubing
  • 모델명 / 제조번호(시리얼번호)
    Lots B151130E2 and B161115E0
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) Distribution and to the states of : NJ, NY, OH, PA, and TX., and to the countries of : Canada, South Korea, Thailand, Australia and Taiwan.
  • 제품 설명
    Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40 || The device is indicated for use as part of an extracorporeal blood circuit for hemodialysis when a monitor will be used to make access flow, recirculation, and/or cardiac output measurements during the patient s hemodialysis treatment.
  • Manufacturer
    Transonic Systems Inc

Manufacturer

Transonic Systems Inc