International Medical Devices Database

Manufacturer Address
NxStage Medical, Inc., 350 Merrimack Street, Lawrence MA 01843-1748
Manufacturer Parent Company (2017)
Nxstage Medical Inc
Source
USFDA
17 Events

14 devices in the database

NxStage

Model / Serial
Software version 4.9 and 4.10
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution.
Product Description
NxStage System One S Cycler -High Permeability Hemodialysis System || Model no. NX1000-4

NxStage System One

Model / Serial
Software versions 4.9 and 4.10
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution. US Nationwide, Netherlands, and Sweden.
Product Description
NxStage System One S Cycler (High Permeability Hemodialysis System) || Model no. NX1000-5-A

Device Recall NxStage Dialysate Sack (SAK) with Concentrate

Model / Serial
Lot code: 40179074
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA (nationwide) and Internationally to France, Netherlands, Spain, Sweden, and the UK.
Product Description
NxStage Dialysate Sack (SAK) with Concentrate || for Use with PureFlow SL || REF: SAK-407 || Lactate 40, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, || Chloride 105, Glucose (mg/dL) 100 || Batch Size (liters) 50

Device Recall NxStage Dialysate Sack (SAK) with Concentrate

Model / Serial
Lot code: 40179126 40179125 40179108 40179036 40179035 31279119 3057923 3057907 3047927
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA (nationwide) and Internationally to France, Netherlands, Spain, Sweden, and the UK.
Product Description
NxStage Dialysate Sack (SAK) with Concentrate || for Use with PureFlow SL || REF: SAK-307 || Lactate 40, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, || Chloride 105, Glucose (mg/dL) 100 || Batch Size (liters) 50 || The SAK is one of the disposables used with NxStage PureFlow SL Dialysate Preparation System. The SAK is a disposable bag pre-filled with dialysate concentrate that is then filled with purified water prepared by NxStage PureFlow SL Dialysate Preparation System to prepare a batch of dialysate for use with the NxStage System One. SAKs are packaged in a case containing two SAKs. SAK product SKUs vary in the dialysate concentrate and volume of the final dialysate batch.

Device Recall NxStage Dialysate Sack (SAK) with Concentrate

Model / Serial
Lot codes: 31279092 3047917 3047916
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA (nationwide) and Internationally to France, Netherlands, Spain, Sweden, and the UK.
Product Description
NxStage Dialysate Sack (SAK) with Concentrate || for Use with PureFlow SL || REF: SAK-306 || Lactate 45, Potassium 2, Sodium 140, Calcium 3, Magnesium 1, || Chloride 101, Glucose (mg/dL) 100 || Batch Size (liters) 50 || The SAK is one of the disposables used with NxStage PureFlow SL Dialysate Preparation System. The SAK is a disposable bag pre-filled with dialysate concentrate that is then filled with purified water prepared by NxStage PureFlow SL Dialysate Preparation System to prepare a batch of dialysate for use with the NxStage System One. SAKs are packaged in a case containing two SAKs. SAK product SKUs vary in the dialysate concentrate and volume of the final dialysate batch.

9 more

4 manufacturers with a similar name

Learn more about the data here

NxStage Medical, Inc._Dirinco

Manufacturer Parent Company (2017)
Nxstage Medical Inc
Manufacturer comment
Note published by the authorities from the Netherlands: This message is a warning from the manufacturer. After placing a medical device on the market, the manufacturer is obliged to follow the device and, where necessary, to improve it. When there is a risk for the user, the manufacturer must take action. The manufacturer informs users and the inspection of this action with a warning (Field Safety Notice). See also medical device warnings. This is part of the supervision of medical technology.
Source
IGJ

NxStage Medical, Inc.

Manufacturer Address
NxStage Medical, Inc., 439 S Union St Fl 5th, Lawrence MA 01843-2837
Manufacturer Parent Company (2017)
Nxstage Medical Inc
Source
USFDA

NxStage Medical, Inc.

Manufacturer Address
NxStage Medical, Inc., 439 South Union Street, 5th Floor, Lawrence MA 01843-2800
Source
USFDA

NxStage Medical, Inc.

Manufacturer Parent Company (2017)
Nxstage Medical Inc
Source
RLMPH

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

Stories in your inbox

Do you work in the medical industry? Or have experience with a medical device? Our reporting is not done yet. We want to hear from you.

Tell us your story!

Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

Download the data

The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

Download all (zipped)