Device Recall NxStage Dialysate Sack (SAK) with Concentrate

Lot codes: 40279015 40179163 40179162 31279127 3067903 3057931 3057930 3047933 3047928

Gastroenterology-Urology Devices

2

No

Worldwide Distribution - USA (nationwide) and Internationally to France, Netherlands, Spain, Sweden, and the UK.

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.

Lot codes: 40179127  40179107  40179109  40179105  40179093  40179034 31279120  31279118  3057921  3057920  3057915  3057914  3057906  3057905 3047924 3047923

Gastroenterology-Urology Devices

2

No

Worldwide Distribution - USA (nationwide) and Internationally to France, Netherlands, Spain, Sweden, and the UK.

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.

Lot codes: 40179030 3067904 3067902  3057925  3057924  3047934  3047929

Gastroenterology-Urology Devices

2

No

Worldwide Distribution - USA (nationwide) and Internationally to France, Netherlands, Spain, Sweden, and the UK.

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.

Lot code: 40179091 40179069  40179068 40179029  40179019  31279094  3067901  3057932  3057919  3057918  3057909  3057908

Gastroenterology-Urology Devices

2

No

Worldwide Distribution - USA (nationwide) and Internationally to France, Netherlands, Spain, Sweden, and the UK.

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.

Lot codes: 40179026 3057901 3047930

Gastroenterology-Urology Devices

2

No

Worldwide Distribution - USA (nationwide) and Internationally to France, Netherlands, Spain, Sweden, and the UK.

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