Recall Z-2210-2016— Terumo Cardiovascular Systems Corporation

Class II FDA medical device recall by Terumo Cardiovascular Systems Corporation, initiated 2016-06-08, terminated 2017-08-04. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..

Recalling firm

Terumo Cardiovascular Systems Corporation

Classification

Class II

Status

Terminated

Initiated

2016-06-08

Terminated

2017-08-04

Firm location

Ann Arbor, MI, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.