Device Recall ICU STAT 2 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 ICU Medical, Inc. 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
    69088
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-2620-2014
  • 사례 시작날짜
    2014-08-19
  • 사례 출판 날짜
    2014-09-19
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2014-11-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Stopcock, i.V. Set - Product Code FMG
  • 원인
    Icu is recalling the conmed stat 2 flow controller because it may deliver a significantly higher flow rate than was intended.
  • 조치
    ICU Medical sent an Urgent Medical Device Recall letter dated August 19, 2014 to all affected customers. The letter identified the affected product, problems identified and the actions to be taken. Customers were instructed to complete the recall response form and fax to ICU Medical at (801) 264-1755 or by email: recall@icumed.com. Customers with questions or require assistance relating to this recall were instructed to contact ICU Customer Service Monday through Friday between the hours of 8:30 AM and 4:00 PM Pacific time: 866-829-9025 and select option 8, or e-mail the following address: customerservice@icumed.com. For questions regarding this recall call 801-264-1732.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot # 2768417
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) in the state of WA, OR and the country of South Africa.
  • 제품 설명
    STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 60 Drop Primary Set || w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9802. || Product Usage: || IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
  • Manufacturer

Manufacturer

  • 제조사 주소
    ICU Medical, Inc., 951 Calle Amanecer, San Clemente CA 92673-6212
  • 제조사 모회사 (2017)
  • Source
    USFDA