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Terumo Cardiovascular Systems Corporation recalls Sarns " TCM II Temperature Control Module The Sarns" TCM II Temperature Control Module is a source of temperature-con
Recalled July 3, 2013 · FDA recall Z-1569-2013 · Terumo Cardiovascular Systems
Hazard
Internal testing found certain Sarns" TCM II systems were released with incorrectly assembled heatsink assemblies which could cause the units to fail. · FDA Class II
Units
7 units
Sold at
Worldwide Distribution including the countries of UAE (United Arab Emirates) HONG KONG and THAILAND. Not distributed in USA
Description
Internal testing found certain Sarns" TCM II systems were released with incorrectly assembled heatsink assemblies which could cause the units to fail.
Product
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
Manufacturer(s)
Terumo Cardiovascular Systems Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →