Reported Aug 22, 2018 · Terminated
NxStage Express Fluid Warmer (FW-300, FW-300-A, FW-300-WW, FW-301, FW-301-A) Product Usage: The NxStage Express Fluid…
NxStage Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: NxStage Medical, Inc. · 350 Merrimack St · Lawrence, MA · 01843-1748
Is this the product you have?
NxStage Express Fluid Warmer (FW-300FW-300-AFW-300-WWFW-301
- FW-301-A) Product UsageThe NxStage Express Fluid Warmer is an accessory to the NxStage System One used to warm therapy fluids prior to administration
- Lot codes and dates
- All units are affected. As of 6/11/18, the last serial number manufactured was W35452.
- Amount recalled
- 14975
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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