Agency classClass IIOur severity:Severe FDA (Devices)·Z-2793-2018·Announced 2018-08-22

NxStage Express Fluid Warmer Recalled for Electrical Fire Risk

NxStage Medical is recalling Express Fluid Warmers due to a potential risk of electrical fire if fluid leaks into the power receptacle.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a potential risk of electrical fire with seven reported incidents of smoke, sparks, or flames, which meets the criteria for 'significant injury/property-damage reports' or high-risk hazard classification.

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.

Lot numbers (2)

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

Distribution

Distributed nationwide across the United States.

Same manufacturer · NxStage Medical, Inc.

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Same hazard · fire