Thermedx LLC recalls Fluid Management System P4000; for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warmi…

Recall date

September 1, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1463-2015

FDA classification

Class II

Brand / firm

Thermedx LLC

Sold / distributed

US Distribution to the states of : OH, MS, MA, WA, MI, NC, NY, WV, LA, TX and IL.

Why it was recalled

To correct software bugs that could affect the ability to accurately measure fluid deficit.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.