Brand
Nxstage Medical, Inc. Recalls
16 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Nxstage Medical, Inc..
16Total Recalls
0Critical
1.6MUnits Affected
Aug 27, 2019Most Recent
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 Devices1,803 affectedAug 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 Devices3,940 affectedApr 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 Devices21,071 affectedOct 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 Devices59,100 affectedOct 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 Devices15,880 affectedOct 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 Devices186,476 affectedOct 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 Devices7,275 affectedOct 17, 2018
High RiskFDA
Nxstage Medical, Inc.
NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One
Medical Devices1,243,400 affectedNov 10, 2017
High RiskFDA
Nxstage Medical, Inc.
NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5
Medical Devices323 affectedOct 29, 2015
High RiskFDA
Nxstage Medical, Inc.
NxStage System One S Cycler -High Permeability Hemodialysis System Model no. NX1000-4
Medical Devices7 affectedOct 29, 2015
High RiskFDA
Nxstage Medical, Inc.
NxStage System One S Cycler - Model no. NX1000-3-A (OUS). For home hemodialysis.
Medical Devices133 affectedOct 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 Devices19,423 affectedMay 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 Devices2,839 affectedMay 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 Devices16,625 affectedMay 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 Devices969 affectedJan 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 Devices1,480 affectedMar 18, 2013