Date of Enforcement Report: 4/29/2015
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.
Recall Number Z-1463-2015
To correct software bugs that could affect the ability to accurately measure fluid deficit..
Thermedx LLC, Solon, OH on 9/1/2014 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
US Distribution to the states of : OH, MS, MA, WA, MI, NC, NY, WV, LA, TX and IL.