Events

RAPIDLyte Arterial Blood Sampling Line Draw Syringes3 mL Line Draw, 70 IU, Aspirating, L/L 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Siemens Ltd Diagnostics Division 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-2013-RN-01310-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-12-20
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01310-1
  • 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
    Siemens is advising of an issue with rapidlyte arterial blood syringes when used with radiometer brand blood gas analysers. the plunger tip in the rapidlyte 3ml arterial draw line does not remain stationary when the probe of the analyser extends into the syringe. this can result in difficulties aspirating the sample or the plunger may get pushed out of the syringe.
  • 조치
    Siemens is advising their customers to cease using RAPIDLyte syringes on Radiometer Blood Gas systems. The syringes can continue to be used on any Siemens Blood Gas Analysers.

Device

RAPIDLyte Arterial Blood Sampling Line Draw Syringes3 mL Line Draw, 70 IU, Aspirating, L/L
  • 모델명 / 제조번호(시리얼번호)
    RAPIDLyte Arterial Blood Sampling Line Draw Syringes3 mL Line Draw, 70 IU, Aspirating, L/LReference number: 04180028Siemens Part Number: 103202963 mL Line Draw, 21 IU, Aspirating, L/LReference number: 06194484Siemens Part Number: 103239253 mL Line Draw, 70 IU, Aspirating, L/LReference number: 06380806Siemens Part Number: 104909663 mL Line Draw, 70 IU, Aspirating, L/SReference number: 00355281Siemens Part Number: 10313293Multiple lot numbers affected
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division