Device Recall Transpac Trifurcated monitoring kit with Safeset Reservoir 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
    68971
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2162-2014
  • 사례 시작날짜
    2014-07-18
  • 사례 출판 날짜
    2014-08-07
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2014-09-25
  • 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
    Transducer, blood-pressure, extravascular - Product Code DRS
  • 원인
    Icu has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.
  • 조치
    ICU Medical, Inc. sent an email dated July 18, 2014, to their customers, The email inform the customer of the problem and the action to be taken. The email stated that the US Sales Representative would remove the recalled product on July 22, 2014. If product was further distribution customers should notify their customers. Customer was informed of the RGA to have the recalled product returned. For questions regarding this recall call 801-264-1732.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot No. 2841690, 2841691, 2859331
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including Oregon and Internationally to Australia.
  • 제품 설명
    Arterial Transpac IT Monitoring Kit w/Safeset Reservoir, 03 ml Flush Device and 2 CSP, Item No. 011-46106-72 || Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion, and blood withdrawal.
  • Manufacturer

Manufacturer

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