Device Recall Plastic Dignity Low Profile CT Port

  • Model / Serial
    Lot # MHGB030 Exp. Date 2020-07-30
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Arabia, Australia, Israel, Brunei & Jamaica
  • Product Description
    6.6F Plastic Dignity¿ Low Profile CT Port W/Attachable ChronoFlex¿ Polyurethane Catheter, Catalog # MRCTI66041, UDI#- 884908031157 || Product Usage: || Indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with a power injectable needle, the Power Injectable Implantable Infusion Port device is indicated for power injection of contrast media.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Medical Components, Inc dba MedComp, 1499 Delp Dr, Harleysville PA 19438-2936
  • Manufacturer Parent Company (2017)
  • Source
    USFDA