Device Recall NXStage PureFlow SL SAK303

  • 모델명 / 제조번호(시리얼번호)
    Lot 1117911, Exp. 2013-09
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution.
  • 제품 설명
    NXStage PureFlow SL SAK-303 - 2 dialysate sacks (SAK) with concentrate for use with PureFlow SL, Rx || The NxStage PureFLow SL is an optional accessory to the NxStage System One that prepares dialysate for use during hemodialysis, as prescribed by the physician.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    NxStage Medical, Inc., 439 S Union St Fl 5th, Lawrence MA 01843-2837
  • 제조사 모회사 (2017)
  • Source
    USFDA