Skip to main content
All Recalls

Every Nxstage Medical, Inc. Recall

Sorted by most recent. Click any recall for full details.

16 recalls
High RiskFDA
Nxstage Medical, Inc.
Low Volume Cartridge IFU (SKU CAR-125-B) used with the following devices: 1) NxStage One, Model NX1000-1; 2) NxStage VersiHD Cycler, ...
Medical Devices·1,803 affected·Aug 27, 2019
High RiskFDA
Nxstage Medical, Inc.
NxStage PureFlow B Solution, REF RFP-401, M535RPF4010 NxStage PureFlow B Solution is indicated for use with renal replacement therapy ...
Medical Devices·3,940 affected·Apr 11, 2019
High RiskFDA
Nxstage Medical, Inc.
NxStage PureFlow B Solution-RFP-402, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal ...
Medical Devices·21,071 affected·Oct 17, 2018
High RiskFDA
Nxstage Medical, Inc.
NxStage PureFlow B Solution-RFP-400, Premixed Dialysate for Hemodialysis. NxStage PureFlow B Solution is indicated for use with ren...
Medical Devices·59,100 affected·Oct 17, 2018
High RiskFDA
Nxstage Medical, Inc.
NxStage PureFlow B Solution-RFP-RFP-456, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with re...
Medical Devices·15,880 affected·Oct 17, 2018
High RiskFDA
Nxstage Medical, Inc.
NxStage PureFlow B Solution-RFP-401, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal ...
Medical Devices·186,476 affected·Oct 17, 2018
High RiskFDA
Nxstage Medical, Inc.
NxStage PureFlow B Solution-RFP-RFP-454, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with re...
Medical Devices·7,275 affected·Oct 17, 2018
High RiskFDA
Nxstage Medical, Inc.
NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One
Medical Devices·1,243,400 affected·Nov 10, 2017
High RiskFDA
Nxstage Medical, Inc.
NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5
Medical Devices·323 affected·Oct 29, 2015
High RiskFDA
Nxstage Medical, Inc.
NxStage System One S Cycler -High Permeability Hemodialysis System Model no. NX1000-4
Medical Devices·7 affected·Oct 29, 2015
High RiskFDA
Nxstage Medical, Inc.
NxStage System One S Cycler - Model no. NX1000-3-A (OUS). For home hemodialysis.
Medical Devices·133 affected·Oct 29, 2015
High RiskFDA
Nxstage Medical, Inc.
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-302 Lactate , 40, Potassium 1, Sodium 140, Calcium 3, ...
Diabetes Devices·19,423 affected·May 14, 2014
High RiskFDA
Nxstage Medical, Inc.
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-305 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Ma...
Diabetes Devices·2,839 affected·May 14, 2014
High RiskFDA
Nxstage Medical, Inc.
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-304 Lactate 45, Potassium 2, Sodium 140, Calcium 3,Mag...
Diabetes Devices·16,625 affected·May 14, 2014
High RiskFDA
Nxstage Medical, Inc.
NxStage PureFlow-B Solution; Model/Catalog Number: RFP-401. Product is packaged in a case containing two individual 5L bags. The Nx...
Medical Devices·969 affected·Jan 24, 2014
High RiskFDA
Nxstage Medical, Inc.
NxStage PureFlow-B Solution, Model/Catalog Number: RFP-401, packaged in a case The NxStage PureFLow-B Solution is indicated for use w...
Medical Devices·1,480 affected·Mar 18, 2013