Device Recall The Sarns Dual CoolerHeater

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)

Cardiovascular Devices

2

No

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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.