Device Recall BioStable 5F SL55CM IR145 Kit Valved

  • 모델명 / 제조번호(시리얼번호)
    Lot 4906931
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution: US (Nationwide) and countries of:; Canada, Great Britain, Netherlands, South Australia and Spain.
  • 제품 설명
    Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, UPN H965458180, Catalog No. 45-818 || The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; and for power injection of contrast media. Non-Valve lumens are indicated for central venous pressure monitoring.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Angiodynamics Inc. (Navilyst Medical Inc.), 10 Glens Falls Tech Park, Glens Falls NY 12801-3864
  • 제조사 모회사 (2017)
  • Source
    USFDA