NxStage Medical product recalled over fire hazard

Recall date

June 11, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

NxStage Medical, Inc. recalls NxStage Express Fluid Warmer (FW-300, FW-300-A, FW-300-WW, FW-301, FW-301-A) Product Usage: The NxStage Express Fluid W…

Recall number

Z-2793-2018

FDA classification

Class II

Brand / firm

NxStage Medical, Inc.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.