Manufacturers

Thermedx LLC

2 devices in the database

Fluid Management System P4000
  • Model / Serial
    Serial Numbers 20100001 through 20140044
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : OH, MS, MA, WA, MI, NC, NY, WV, LA, TX and IL.
  • Product Description
    Fluid Management System P4000; for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic procedures.
Device Recall Thermedx Fluid Management System
  • Model / Serial
    Model P4000 Serial numbers affected:  20110004, 20110007, 20110015, 20110025, 20130001-20130032, 20140001-20140005
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including HI, MS, NY, OH, PA, VA, WA, WV, and IL.
  • Product Description
    The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate, distend, and debride while warming the fluid to assist in the prevention of peri-operative hypothermia. The fluid is warmed via an internal infrared mechanism. Additionally the system will hold suction canisters for the collection of used irrigant.