Events

Device Recall INOvent, Nitric Oxide Delivery System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 INO Therapeutics, 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
    35892
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1410-06
  • 사례 시작날짜
    2006-06-29
  • 사례 출판 날짜
    2006-08-25
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2007-07-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47097
  • 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
    Nitric Oxide Delivery System - Product Code MRN
  • 원인
    The kel-f tip mounted on the high pressure hose can become dislodge/lodged in the inomax valve outlet.
  • 조치
    On June 29, 2006, the firm sent a letter to its consignees advising them to visually verify that the Kel F tip is in place before attempting to connect either of the high pressure hoses to the INOmax cylinders. INO advised that if the tip was not in place, the operator should immediately replace the tip before attaching the hoses. On July 5, 2005, the firm sent a second letter to their consignees with extra Kel F tips and existing instructions from the INOvent Operation & Maintenance Manual outlining the proper replacement procedure for the tips. The firm is following with telephone contact to assure that the letters were delivered to the proper person(s).

Device

Device Recall INOvent, Nitric Oxide Delivery System
  • 모델명 / 제조번호(시리얼번호)
    All serial numbers for Model #1605-9000-000
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide, USA and countries of Canada, Uruguay, Chile, Argentina, Colombia, and Malaysia
  • 제품 설명
    INOvent, Nitric Oxide Delivery System. Model Number 1605-9000-000
  • Manufacturer
    INO Therapeutics, Inc.

Manufacturer

INO Therapeutics, Inc.
  • 제조사 주소
    INO Therapeutics, Inc., 6 State Route 173, Clinton NJ 08809-1269
  • Source
    USFDA