Events

Moog Infusion System Administration Sets 340-4114 Non DEHP Microbore Admin Set with Non-Vented Spike Packaged Assy, STERILE340-4166 Non DEHP Microbore Administration Set with Non-Vented Spike ASV Packaged Assy, STERILE340-4134 Non-DEHP Microbore Admin Set with Non-Vented Spike and Y-Site with Check Valve, Packaged Assy, STERILE 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Fresenius Kabi 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-00053-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2018-01-17
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00053-1
  • 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
    Fresenius kabi australia has received notice from the manufacturer, moog medical group, that they have initiated a recall in the usa for certain non-filtered moog iv administration sets manufactured between 9th june 2015 and 6th july 2016. the manufacturer received 7 complaints regarding particulate found on the tip of non-filtered moog iv spike sets manufactured between 9th june 2015 and 6th july 2016. during that period, 1,390,720 non-filtered spike administration sets were manufactured. when found, the loose particulate is located on the external edge of the non-vented spike and can potentially enter into the fluid path. introducing foreign material into the body can cause a range of side effects depending on the particle size and the type of line being used. no complaints have been received in australia to date.
  • 조치
    Fresenius Kabi is advising customers to check inventory and quarantine affected stock. Fresenius Kabi will contact affected users to arrange return of stock.

Device

Moog Infusion System Administration Sets 340-4114 Non DEHP Microbore Admin Set with Non-Vented Sp...
  • 모델명 / 제조번호(시리얼번호)
    Moog Infusion System Administration Sets 340-4114 Non DEHP Microbore Admin Set with Non-Vented Spike Packaged Assy, STERILE340-4166 Non DEHP Microbore Administration Set with Non-Vented Spike ASV Packaged Assy, STERILE340-4134 Non-DEHP Microbore Admin Set with Non-Vented Spike and Y-Site with Check Valve, Packaged Assy, STERILEMultiple Affected Part and Lot NumbersARTG Number: 225965 (Fresenius Kabi Australia Pty Limited - Infusion administration set, infusion pump)
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • Manufacturer
    Fresenius Kabi Australia Pty Ltd

Manufacturer

Fresenius Kabi Australia Pty Ltd