Device Recall Celsite Implantable Access Port System

  • 모델명 / 제조번호(시리얼번호)
    Lot number: 36896615
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    CA and NY only.
  • 제품 설명
    Celsite Implantable Access Port System, model ST301. The Celsite Implantable Access Port Systems (Celsite port systems) are implantable port and catheter systems that allow safe, repeated access to the patient's bloodstream. The port chamber and catheter design can be used for the administration of medication and fluids. The Celsite system consists of an access port with a silicone septum, which is connected to a catheter using a connection ring. The triangular shaped access port has a low profile nose, finger stops on the side of the housing, and a round base. Celsite access ports have suture holes or suture zones to secure placement during implantation.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    B. Braun Interventional Systems, 3050 Ranchview Ln N, Minneapolis MN 55447-1459
  • 제조사 모회사 (2017)
  • Source
    USFDA