Device Recall 31 cm (12") Smallbore Bifuse Ext Set w/2 NanoClave, Orange Ring, 2

  • 모델명 / 제조번호(시리얼번호)
    Item No. 011-A1097. Lot No. 2781155, 2796667.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.
  • 제품 설명
    31 cm (12") Smallbore Bifuse Ext Set w/2 NanoClave¿, Orange Ring, 2 || Anti Syphon Valves, 0.2 Micron Postive Filter, Clamp, NanoClave¿ TConnector, || Rotating Luer, Part No. A1000, Item No. 011-A1097 || The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    ICU Medical, Inc., 951 Calle Amanecer, San Clemente CA 92673-6212
  • 제조사 모회사 (2017)
  • Source
    USFDA