Device Recall ARROWgard BLUE PLUS Pressure Injectable Quad

  • Model / Serial
    CDA-45854-P1A 13F17C0325 13F17D0283 13F17F0748
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US in the states of OH, FL, SC, TX, KY, NJ, MI
  • Product Description
    ARROWg+ard BLUE PLUS || Pressure Injectable Quad- Lumen CVC Kit || Product Usage: || The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values frequent blood sampling or blood/blood component infusions infusion of incompatible medications central venous pressure monitoring lack of usable peripheral IV sites replacement of multiple peripheral sites for IV access injection of contrast media When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with pressure injectable CVC may not exceed 400 PSI.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Arrow International Inc, 2400 Bernville Rd, Reading PA 19605-9607
  • Manufacturer Parent Company (2017)
  • Source
    USFDA