Preamendments device-Sarns Dual Cooler-Heater. The Sarns Dual Cooler-Heater is a self-contained unit for supplying cold and warm water to heat exchangers during open heart surgery. It supplies water at a rate of up to 6.5 gallons per minute (25 liters per minute) at zero head, and will provide a maximum pressure output of 11 pounds per square inch (76,000 pascals). The Sarns TM Dual Cooler-Heater can be used with heat exchangers capable of accepting these flows and pressures. Product Usage: The Sarns Dual Cooler-Heater is indicated for use as a water supply system to a blood heat exchanger in open-heart surgery.

Reason: Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler devices due to the distributor no longer selling the Inter chlor sanitizer (Product Code 205) referenced in its heater-cooler cleaning instructions.

Code information: The Sarns Dual Cooler-Heater ; Dual Cooler Heater 115V/60Hz (P/N 11160); Dual Cooler Heater 220V/50Hz (P/N 4332); Dual Cooler Heater 1 OOV/60Hz (P/N 14114); Dual Cooler Heater 1 OOV/50Hz (PIN 13460)

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