Events

Hudson RCI One-Way Valve with Capped Monitoring Port 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Teleflex Medical Australia Pty 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
    RC-2018-RN-00307-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2018-04-10
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00307-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    It has been identified by the manufacturer that one-way valves may disconnect at the joint between the two components that make up the device, which would cause an interruption of ventilation to the patient. disconnection of the valve is recognizable by the user as an alarm from the ventilator, oxygen sensor or other compatible device to which the valve is connected. however, disconnection of the valve in ventilator dependent patients without prompt response could lead to hypoxia, organ failure, or death.To date, there have been no injuries reported as a result of this issue.
  • 조치
    Teleflex is advising users to immediately discontinue use and quarantine any products of the affected lot numbers. Teleflex will contact customers with affected product to arrange collection of goods and provide an account credit.

Device

Hudson RCI One-Way Valve with Capped Monitoring Port
  • 모델명 / 제조번호(시리얼번호)
    Hudson RCI One-Way Valve with Capped Monitoring PortProduct Code Number: 1644Lot Numbers: 74K1502092 and 74K1601936ARTG Number: 216042(Teleflex Medical Australia - Valve, non-rebreathing)
  • 의료기기 분류등급
    Anesthesiology Devices
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd