Class 2 Device Recall NxStage Express Fluid Warmer

• Date Initiated by Firm: June 11, 2018
• Create Date: August 14, 2018
• Recall Status: Terminated on April 28, 2020
• Recall Number: Z-2793-2018
• Recall Event ID: 80512
• 510(K)Number: K071263
• Product Classification: Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
• 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.
• Code Information: All units are affected. As of 6/11/18, the last serial number manufactured was W35452.
• Recalling Firm/ Manufacturer: NxStage Medical, Inc.; 350 Merrimack St; Lawrence MA 01843-1748
• For Additional Information Contact: Customer Service; 800-697-8243
• Manufacturer 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 Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KDI