Device Recall BBB3872

  • 모델명 / 제조번호(시리얼번호)
    Lot # 014648 USE BY: 09/01/2018
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution to states of: LA, MI, NY, OH, OR & TX.
  • 제품 설명
    The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB38-72 || A device that isolates pressure tranducers from blood contact when measurements of blood pressure in extracorporeal circuits are made during short and long term procedures. The pressure signal can be used to control pump speed. It is also used as an inline reservoir to provide compliance in the circuit during short and long term procedures. Measures pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Circulatory Technology Inc, 21 Singworth St, Oyster Bay NY 11771-3703
  • 제조사 모회사 (2017)
  • Source
    USFDA