FDAJune 11, 2018device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

nxstage medicalnxstage

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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