Class 2 Device Recall Low Volume Cartridge IFU (SKU CAR125B)

• Date Initiated by Firm: August 27, 2019
• Create Date: December 18, 2019
• Recall Status: Terminated on February 01, 2021
• Recall Number: Z-0697-2020
• Recall Event ID: 83706
• 510(K)Number: K050525
• Product Classification: Dialysis administration kit - Product Code PEV
• Product: Low Volume Cartridge IFU (SKU CAR-125-B) used with the following devices: 1) NxStage One, Model NX1000-1; 2) NxStage VersiHD Cycler, Model Numbers: NX1000-16, and NX1000-16-A; 3) NxStage One, Model Numbers: NX1000-3 and NX1000-3-A; 4) NxStage One, Model Numbers: NX1000-10 and NX1000-10-A
• Code Information: Product 1) UDI # - M535NX100010 Product 2) UDI # - M535NX1000160 and M535NX100016A0 Product 3) UDI # - M535NX100030 and M535NX10003A0 Product 4) UDI # - M535NX1000100 and M535NX100010A0 Lot Numbers: 60677021, 60877053, 70477033, 71177020, 80377002, 80477018, 80877011, 81077018, 81177047, 90277048 and 90677002
• Recalling Firm/ Manufacturer: NxStage Medical, Inc.; 350 Merrimack St; Lawrence MA 01843-1748
• For Additional Information Contact: 978-687-4700
• Manufacturer Reason for Recall: There is a potential patient health risk while performing chronic hemodialysis treatments in the home setting with for patients with low blood volume (2.4 Liters or less in a patient with body weight of 30kg or less) when prescribing larger dialysate volumes.
• FDA Determined Cause: Under Investigation by firm
• Action: On August 27, 2019, NxStage issued URGENT MEDICAL DEVICE CORRECTION notices to customers. Actions to be Taken by Customers: For patients using NxStage System One Cycler, model NX1000-1: - At any dialysate flow rate, the system may have a fluid removal error defined as the greater of 3% of Total Dialysate Volume or 300 ml/12hr. The Total Allowable Error is generally dependent on total dialysate volume processed for this System model. For patients using less than 10L of dialysate per treatment, this model has a minimum Total Allowable Error volume of 300 ml. For patients using NxStage System One S or NxStage VersiHD Cycler, model NX1000-3, NX1000-3A, NX1000-10, NX1000-10A, NX1000-16, or NX1000-16A: - At dialysate flow rates of 3.0 Liters/hour and below, the system may have a fluid removal error defined as the greater of up to 25 ml/hour or 5% of Total Ultrafiltration Volume. The Total Allowable Error is dependent on the error rate and length of treatment and can continue to increase for as long as treatment is being delivered. - At dialysate flow rates of above 3.0 Liters/hour, the system may have a fluid removal error defined as the greater of up to 100 ml/hour or 5% of Total Ultrafiltration Volume. The Total Allowable Error is dependent on the error rate and length of treatment and can continue to increase for as long as treatment is being delivered. NxStage discourages the use of the System for the treatment of low blood volume patients. If the physician considers it appropriate to prescribe home hemodialysis using the NxStage System One for low blood volume patients, the following points should be considered: 1. When performing hemodialysis treatments for low blood volume (2.4 Liters or less in a patient with body weight of 30kg or less) patients, NxStage strongly recommends employment of additional monitoring vigilance. Always ensure that cardiac status and fluid status are monitored for low blood volume patients by monitoring bloo
• Quantity in Commerce: 1803 units
• Distribution: AL, AZ, CA, NC & VA
• 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 = PEV