FDA-Device2013-07-03Class II
Sarns " TCM II Temperature Control Module The Sarns" TCM II Temperature Control Module is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and is indicated for controlling and monitoring patient temperature
Terumo Cardiovascular Systems Corporation
Hazard
Internal testing found certain Sarns" TCM II systems were released with incorrectly assembled heatsink assemblies which could cause the units to fail.
Sold states
Worldwide Distribution including the countries of UAE (United Arab Emirates) HONG KONG and THAILAND. Not distributed in USA
Affected count
7 units
Manufactured in
6200 Jackson Road, Ann Arbor, MI, United States
Products
Sarns " TCM II Temperature Control Module The Sarns" TCM II Temperature Control Module is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and is indicated for controlling and monitoring patient temperature
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1569-2013Don't want to check this manually?
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