Device Recall Celsite Implantable Access Port System

  • Modèle / numéro de série
    Lot number: 36896615
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    CA and NY only.
  • Description du dispositif
    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

Fabricant

  • Adresse du fabricant
    B. Braun Interventional Systems, 3050 Ranchview Ln N, Minneapolis MN 55447-1459
  • Société-mère du fabricant (2017)
  • Source
    USFDA