Z-2793-2018Class II

NxStage Express Fluid Warmer (FW-300, FW-300-A, FW-300-WW, FW-301, FW-301-A)

Name: Z-2793-2018 NxStage Express Fluid Warmer (FW-300, FW-300-A, FW-300-WW, FW-301, FW-301-A)
Creator: NxStage Medical, Inc.
Published: 2018-06-11
License: https://open.fda.gov/license/

NxStage Medical Inc / initiated 2018-06-11 / Terminated

FDA source

NxStage Medical, Inc. began a recall of 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... on 2018-06-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2793-2018
Classification: Class II
Status: Terminated
Initiated: 2018-06-11
Posted: 2018-08-14
Terminated: 2020-04-28
Recalling firm: NxStage Medical Inc
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.
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: 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.
FDA root cause: Use error
Action: On June 11, 2018, the firm distributed Medical Device Product Safety Notices to affected customers and dialysis centers. Patients were contacted either via email or UPS second day air. Dialysis centers were contacted via email. The recall communication alerted customers that the firm has received 7 reports of smoke, sparks, or flames coming from the Express Fluid Warmer since 2016. No adverse health consequences or medical interventions have been reported. The firm informed customers that they were updating the User Guide to add the following new warning language: "Warning: Do not use any fluid bags that are leaking, and use caution not to spill fluids near the warmer. If the warmer is plugged in, leaking or spilled fluids in the warmer power receptacle can cause an electrical short even if the warmer is not being used. This can lead to an electrical fire and risk of serious injury or death. To minimize this risk, do the following: " When not used during treatment, do not plug the Express Fluid Warmer into the cycler. " Check all fluid bags for leaks prior to and during use. " If fluid spills onto the warmer, unplug the warmer power cord from the rear power receptacle and contact Technical Support." Customers were asked to do the following: 1. Please follow the instructions on the attached reply form to confirm that you received this notice. 2. Please observe the above warning and unplug your Express Fluid Warmer when not in use. If you have any questions or comments, please feel free to contact Customer Service at 1-800-NXSTAGE.
Quantity in commerce: 14975
Distribution: Worldwide Distribution - US Nationwide in the countries of Australia, Canada, France, Germany, Italy, Kuwait, Netherlands, Saudi Arabia, Spain, Sweden, and UK.
Product codes and lots: All units are affected. As of 6/11/18, the last serial number manufactured was W35452.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2793-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2793-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-22	2018-08-13

Product code KDI

K071263Class IINxstage Travel Warmer, Models Tw-400 & Fws-500Nxstage Medical, Inc. / cleared 2007-08-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)