Devices

Device Recall Sarns 8000 Roller pump

  • 모델명 / 제조번호(시리얼번호)
    Lots 19937-19944, 19955-19984, 20005-20029, 20035-20038 and 20047.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA including states of CA, FL, NC and NY and countries of United Arab Emirates, China, Ecuador, and Panama.
  • 제품 설명
    Sarns 8000 Roller pump for Sarns System 8000 Heart Lung Machine console, 220V, Catalog No 16407, Terumo Cardiovascular System Corp Ann Arbor, MI. (not distributed in the US) || The system 8000 is indicated for use in extracorporeal circulation of blood for arterial perfusion, reginal perfusion and cardiopulmonary bypass procedures.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation
  • 1 Event

제조사

Terumo Cardiovascular Systems Corporation
  • 제조사 주소
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
  • 제조사 모회사 (2017)
    Terumo Corp.
  • Source
    USFDA

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Device Recall Sarns 8000 Roller pump
  • 모델명 / 제조번호(시리얼번호)
    lots 19945-19954 and 19985-20001.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA including states of CA, FL, NC and NY and countries of United Arab Emirates, China, Ecuador, and Panama.
  • 제품 설명
    Sarns 8000 Roller pump for Sarns System 8000 Heart Lung Machine console, 115V, Catalog No 16402, Terumo Cardiovascular System Corp Ann Arbor, MI. || The system 8000 is indicated for use in extracorporeal circulation of blood for arterial perfusion, reginal perfusion and cardiopulmonary bypass procedures.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation