NxStage Express Fluid Warmer Recalled for Electrical Fire Risk

Plain-English summary

NxStage Medical, Inc. is recalling the NxStage Express Fluid Warmer (models FW-300, FW-300-A, FW-300-WW, FW-301, and FW-301-A). This accessory is used with the NxStage System One to warm therapy fluids prior to administration. The recall affects 14,975 units distributed worldwide, including the United States, Australia, Canada, France, Germany, Italy, Kuwait, the Netherlands, Saudi Arabia, Spain, Sweden, and the UK. All units are affected, with the last serial number manufactured as of June 11, 2018, being W35452.

The recall is being conducted because there is a potential risk of electrical fire if fluid leaks into the power receptacle on the back of the warmer. This risk exists any time the device is plugged in. Since 2016, the firm has received seven reports of smoke, sparks, or flames coming from the Express Fluid Warmer. No adverse events have been reported.

Consumers should stop using the affected devices immediately. They should contact NxStage Medical for further instructions on how to return or replace the units.

The recalled product

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.

Manufacturer

NxStage Medical, Inc.

Category

Medical Device — Dialysis Accessory

Hazard

• fire
• electrical-hazard

Affected units

14,975

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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