NxStage Express Fluid Warmer (FW-300, FW-300-A, FW-300-WW, FW-301, FW-301-A) Product Usage: The NxStage Express Fluid Warmer is an accessory to the NxStage System One used to warm therapy fluids prior to administration.

Reason: There is a potential risk of electrical fire when fluid leaks into the power receptacle on the back of the warmer. The risk exists any time the warmer is plugged in. The firm has received 7 reports of smoke, sparks, or flames coming from the Express Fluid Warmer since 2016. No adverse events have been reported.

Code information: All units are affected. As of 6/11/18, the last serial number manufactured was W35452.

Distribution pattern: Worldwide Distribution - US Nationwide in the countries of Australia, Canada, France, Germany, Italy, Kuwait, Netherlands, Saudi Arabia, Spain, Sweden, and UK.