Devices

Device Recall NxStage Dialysate Sack (SAK) with Concentrate

Model / Serial
Lot codes: 40179030 3067904 3067902 3057925 3057924 3047934 3047929
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-303 || Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 100m || Chloride 100m, 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.
Manufacturer
NxStage Medical, Inc.
1 Event
- Recall of Device Recall NxStage Dialysate Sack (SAK) with Concentrate

Manufacturer

NxStage Medical, Inc.

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

7 devices with a similar name

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Device Recall NxStage Dialysate Sack (SAK) with Concentrate

Model / Serial
Lot codes: 40279015 40179163 40179162 31279127 3067903 3057931 3057930 3047933 3047928
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-301 || Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, || Chloride 100, Glucose (mg/dL) 100 || Batch Size (liters) 60 || 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.
Manufacturer
NxStage Medical, Inc.

Device Recall NxStage Dialysate Sack (SAK) with Concentrate

Model / Serial
Lot codes: 40179127 40179107 40179109 40179105 40179093 40179034 31279120 31279118 3057921 3057920 3057915 3057914 3057906 3057905 3047924 3047923
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-302 || Lactate , 40, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, Chloride 105, Glucose (mg/dL) 100, || Batch Size (liters): 60 || 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.
Manufacturer
NxStage Medical, Inc.

Device Recall NxStage Dialysate Sack (SAK) with Concentrate

Model / Serial
Lot code: 40179091 40179069 40179068 40179029 40179019 31279094 3067901 3057932 3057919 3057918 3057909 3057908
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-304 || Lactate 45, Potassium 2, Sodium 140, Calcium 3,Magnesium 1, || Chloride 101, Glucose (mg/dL) 100 || Batch Size (liters) 60 || 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.
Manufacturer
NxStage Medical, Inc.

Device Recall NxStage Dialysate Sack (SAK) with Concentrate

Model / Serial
Lot codes: 40179026 3057901 3047930
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-305 || Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 1 || Chloride 100, Glucose (mg/dL) 100 || Batch Size (liters) 40
Manufacturer
NxStage Medical, Inc.

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.
Manufacturer
NxStage Medical, Inc.

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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.

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