Cl II Thermedx Fluid Management System P4000

Company:Thermedx LLC
Date of Enforcement Report: 4/29/2015
Class lI:

PRODUCT

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

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

RECALLING FIRM/MANUFACTURER
Thermedx LLC, Solon, OH on 9/1/2014 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
127 units

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

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Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.