Subsystem, Proportioning
Gastroenterology, Urology · 21 CFR 876.5820
Recent MDR events
20 adverse event reports on file
- NXSTAGE SYSTEM ONEJul 1, 2026InjuryNxstage Medical, Inc.3003464075-2026-00055
- NXSTAGE PUREFLOW PAKJun 17, 2026MalfunctionNxstage Medical, Inc.MW5189521
- NXSTAGE PUREFLOW PAKJun 17, 2026MalfunctionNxstage Medical, Inc.MW5189522
- NXSTAGE SYSTEM ONEDec 19, 2025InjuryNxstage Medical, Inc.3003464075-2025-00137
- NXSTAGE SYSTEM ONEDec 4, 2025MalfunctionNxstage Medical, Inc.3003464075-2025-00124
- NXSTAGE SYSTEM ONESep 3, 2025InjuryNxstage Medical, Inc.3003464075-2025-00098
- NXSTAGE SYSTEM ONEJan 10, 2025MalfunctionNxstage Medical, Inc.3003464075-2025-00025
- NXSTAGE SYSTEM ONEMay 5, 2023InjuryNxstage Medical, Inc.3003464075-2023-00039
- NXSTAGE SYSTEM ONEApr 3, 2023InjuryNxstage Medical, Inc.3003464075-2023-00029
- NXSTAGE SYSTEM ONESep 20, 2022MalfunctionNxstage Medical, Inc.3003464075-2022-00053
Event type breakdown
Most-reported manufacturers
Recalls
10 recall events for this product code
- NxStage Medical, Inc.TerminatedJun 24, 2014
NxStage Dialysate Sack (SAK) with Concentrate
SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
Z-1854-2014 · View FDA record ↗ - NxStage Medical, Inc.TerminatedJun 24, 2014
NxStage Dialysate Sack (SAK) with Concentrate
SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
Z-1855-2014 · View FDA record ↗ - NxStage Medical, Inc.TerminatedJun 24, 2014
NxStage Dialysate Sack (SAK) with Concentrate
SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
Z-1856-2014 · View FDA record ↗ - NxStage Medical, Inc.TerminatedJun 24, 2014
NxStage Dialysate Sack (SAK) with Concentrate
SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
Z-1857-2014 · View FDA record ↗ - NxStage Medical, Inc.TerminatedJun 24, 2014
NxStage Dialysate Sack (SAK) with Concentrate
SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
Z-1858-2014 · View FDA record ↗ - NxStage Medical, Inc.TerminatedJun 24, 2014
NxStage Dialysate Sack (SAK) with Concentrate
SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
Z-1859-2014 · View FDA record ↗ - NxStage Medical, Inc.TerminatedJun 24, 2014
NxStage Dialysate Sack (SAK) with Concentrate
SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
Z-1860-2014 · View FDA record ↗ - NxStage Medical, Inc.TerminatedJun 24, 2014
NxStage Dialysate Sack (SAK) with Concentrate
SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
Z-1861-2014 · View FDA record ↗ - NxStage Medical, Inc.TerminatedJan 20, 2012
NXStage PureFlow SL SAK-303 - 2 dialysate sacks (SAK) with concentrate for use with PureFlow SL, Rx
Report of high conductivity failure alarms with the PureFlow SL due to excess concentrate by weight in the product (SAK) dialysate Preparation System
Z-0826-2012 · View FDA record ↗ - NxStage Medical, Inc.TerminatedUnknown
NxStage Dialysate Sack: 1) REF SAK-301 UDI-M535SAK3010, 2) REF SAK-302 UDI-M535SAK3020, 3) REF SAK-303 UDI-M535SAK3030, 4) REF SAK-304 UDI-M535SAK3040, 5) REF S
May contain endotoxin levels which have been confirmed to exceed the ANSI/AAMI quality standard dialysis fluid of 0.5 EU/ml when used to prepare product.
Z-0811-2018 · View FDA record ↗
Registered firms
5 firms currently registered for this product code
510(k) clearances
12 clearances for this product code
- Nxstage Medical, Inc.May 15, 2014
K140571 · NXSTAGE PUREFLOW SL
- Nxstage Medical, Inc.Sep 19, 2011
K111174 · NXSTAGE PUREFLOW SL
- Nxstage Medical, Inc.Oct 15, 2008
K080919 · NXSTAGE PUREFLOW SL
- Nxstage Medical, Inc.Mar 31, 2006
K060296 · NXSTAGE DIALYSATE PREPARATION MODULE
- Nxstage Medical, Inc.Mar 17, 2005
K043436 · NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269
- Sartorius Filters, Inc.Jun 4, 1985
K850435 · SARTORIUS AQUASART SM 40035 - DIALYSATE SYS
- Travenol Laboratories, S.A.Mar 20, 1985
K850756 · AUTO-D AUTOMATIC DISINFECTION ACCESS/ATTACHMENTS
- Trimedyne, Inc.Jun 16, 1981
K810605 · CHEMATIC BICARBONATE DIALYSATE SYSTEM