Events

Pico 70 Arterial blood sampler (used with Radiometer Blood Gas Analysers) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Radiometer Pacific 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-01500-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2016-11-16
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01500-1
  • 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
    Radiometer has recently become aware of a potential issue with the pico 70 arterial blood sampler, 956-522 of lot rw-55. it has been reported overseas that some needles seem to be corroded. the use of an arterial blood sampler contaminated with rust particles could lead to blood stream infection and organ damage. to date, no incidences have been reported in australia.
  • 조치
    Radiometer is requesting customers to quarantine stock from lot 956-522RW55. Radiometer will arrange for the collection of the affected product and replacement of this stock. Patients that have been exposed to the affected lot of Pico 70 Arterial blood sampler should be closely monitored for signs of infection or other adverse events. This action has been closed-out on 28/02/2018.

Device

Pico 70 Arterial blood sampler (used with Radiometer Blood Gas Analysers)
  • 모델명 / 제조번호(시리얼번호)
    Pico 70 Arterial blood sampler (used with Radiometer Blood Gas Analysers) Lot Number: 956-522RW55ARTG Number: 135319
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd