Events

Transpac Monitoring Kits Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm Strap, Patient Mount; Arterial Transpac IT Monitoring Kit w/Safeset Reservoir, 03 ml Flush Device and 2 CSP 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-2014-RN-00877-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-08-08
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00877-1
  • 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
    Icu medical has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak. a leaking luer may have the potential effect of blood leakage or air embolism which may be life threatening or cause permanent severe injury or illness to the patient. there have been no reports of patient injury due to this problem.
  • 조치
    ICU Medical Australia Pty Ltd is requesting their customers to inspect their stocks and quarantine all units from the affected lots. This action has been closed-out on 03/06/2016.

Device

Transpac Monitoring Kits Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcr...
  • 모델명 / 제조번호(시리얼번호)
    Transpac Monitoring KitsArterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm Strap, Patient Mount Item Number: 011-46104-42Lot Numbers: 2841944, 2841945, 2859326, 2865873 & 2869445Arterial Transpac IT Monitoring Kit w/Safeset Reservoir, 03 ml Flush Device and 2 CSP Item Number: 011-46106-72Lot Numbers: 2841690, 2841691 & 2859331ARTG Number: 206780
  • 의료기기 분류등급
    Cardiovascular Devices
  • Manufacturer
    ICU Medical Australia Pty Ltd

Manufacturer

ICU Medical Australia Pty Ltd
  • Source
    DHTGA