Device Recall CAPIOX Flexible Venous Reservoir

  • 모델명 / 제조번호(시리얼번호)
    CAPIOX Flexible Venous Reservoir, Lot NE13, (used as single units) or as a component in sterilized custom cardiovascular procedure kits with kit lot numbers NC21 R, ND21 R, NF02, and NF02.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    (USA) Nationwide Distribution including states of: FL, MI, MT, NY, TN and VA.
  • 제품 설명
    CAPIOX¿ Flexible Venous Reservoirs, 1500 mL, product codes: CXFVR1500X and CXFVRI500XC, used singly or packaged as components in cardiovascular procedure trays labeled in part ***Terumo Caerdiovascular Systems Corporation, Elkton, MD 21921*** || Product Usage: The reservoir bag is intended for use as a blood collection and storage device during cardiopulmonary bypass procedures. The device is intended for use in conjunction with blood-gas oxygenators in the extra-corporeal circuit. The device may be used in procedures lasting up to 6 hours.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Terumo Cardiovascular Corporation, 125 Blue Ball Rd, Elkton MD 21921-5315
  • 제조사 모회사 (2017)
  • Source
    USFDA