Device Recall Terumo

  • 모델명 / 제조번호(시리얼번호)
    Product Code: SV-S25FL35 Lot Numbers 1508023, 1509011 and 1510004.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    California
  • 제품 설명
    Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code: SV-S25FL35.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Terumo Medical Corp, 2101 Cottontail Lane, Somerset NJ 08873-1277
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 138 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Serial numbers 0001-0003, 1001-1084 and 1101-1116.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution: AR, CA, CO, CT, FL, HI, IA, IL, KS, LA, MD, MI, MO, MS, NY, OH, PA, TX, UT, WA and WI.
  • 제품 설명
    Terumo HX2 Temperature Management System 120V, 50/60 Hz catalog number 809810, Terumo Cardiovascular Systems Corp., Ann Arbor MI. || The Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly control the temperature of the patients blood and cardioplegia solution during cardiovascular bypass surgery. The system consists of a water tank, circulating pumps, heater manifolds, mercury free temperature sensors, water detectors, mixing valves and a tank divider which is provided to partition the tank into two separate channels.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot: ME05
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distribution USA and Canada
  • 제품 설명
    Terumo Cardiovascular Procedure Kit Custom || Open Perfusion Pack || P/N 64937
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot: ME19
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distribution USA and Canada
  • 제품 설명
    Terumo Cardiovascular Procedure Kit Custom || CONDUCER/MP4 8:1 NO RECIRC. DOUBLE SPIKE || P/N: 71032
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    01198, 01205-01241, 01243-01281, 01283-01399, 01401-01404, 01406-01422, 01424-01433, 01435-01554, 01556-01564, 01565-01581, 01583-01609, 01611, 01613-01660, 01662-01721, 01724-01725.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US, Austrailia, Belgium, Canada, Chile, Columbia, Costa Rica, Dominican Republic, Guatamala, Hong Kong, Indonesia, Japan, Korea, Malaysia, Mexico, Phillipines, Saudi Arabia, Singapore, Taiwan, Thailand, United Arab Emirates, and Vietnam
  • 제품 설명
    Air bubble detect module, catalog 802110, Terumo Cardiovascular System Corp, Ann Arbor, MI. || The air bubble detect module is used with an air sensor to detect gross air bubbles in the perfusion circuit.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    00632-00635, 00638, 00642-00711, 00713-00715, 00717-00741, 00752-00813, 00815-00821, 00823-00864, 00867, 00869-00874.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US, Austrailia, Belgium, Canada, Chile, Columbia, Costa Rica, Dominican Republic, Guatamala, Hong Kong, Indonesia, Japan, Korea, Malaysia, Mexico, Phillipines, Saudi Arabia, Singapore, Taiwan, Thailand, United Arab Emirates, and Vietnam
  • 제품 설명
    Occluder module, catalog 803480, Terumo Cardiovascular System Corp, Ann Arbor, MI. || The occluder module is used with the Occluder head to provide a computer controlled tube clamping mechanism to regulate the flow in the venous line.
  • Manufacturer
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