Events

Blood Pressure Monitoring Kits with Transpac IV Transducers 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 ICU 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-2016-RN-01335-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-10-19
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01335-1
  • 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 that there is a potential for leaks with certain monitoring kits that contain the transpac iv transducers. a small number of these devices may have the potential to leak or introduce small amounts of air into the line. in a worst case, there is potential patient harm due to air embolism or contamination. icu medical, inc. has not received any reports of adverse events associated with this issue.
  • 조치
    ICU Medical is advising customers to arrange for their stock to be recovered and replacement stock, or a credit note to be issued. This action has been closed-out on 24/05/2017.

Device

Blood Pressure Monitoring Kits with Transpac IV Transducers
  • 모델명 / 제조번호(시리얼번호)
    Blood Pressure Monitoring Kits with Transpac IV TransducersKit - Royal Women Hospital QLD, Special Care Nursery (Item: 011-0J069-01, Lot: 3253136)Kit - Neonatal/Childrens Australia (Item: 011-46103-16, Lot: 3263780)Safeset Transpac IV (Item: 011-46103-25, Lot: 3207778)Transpac IV (Item: 011-46104-49, Lot: 3242280)Single Line Monitoring Kit w/Transpac IV (Item: 011-46104-52, Lot: 3253165)Single Line Transpac IV Monitoring Kit (Item: 011-46107-16, Lot: 3235355)ARTG Number: 195624
  • Manufacturer
    ICU Medical Australia Pty Ltd

Manufacturer

ICU Medical Australia Pty Ltd
  • Source
    DHTGA