medical Class II Updated 2018-08-22

NxStage Medical, Inc. recalls NxStage Express Fluid Warmer (FW-300, FW-300-A, FW-300-WW, F

Recalled Product

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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All units are affected. As of 6/11/18, the last serial number manufactured was W35452.
View official government recall

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