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Medium RiskFDA Device

NxStage Medical, Inc.: SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification

Agency Publication Date: June 24, 2014
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Affected Products

Product: 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 dialys

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

Lot Numbers:
codes
Product: 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 d

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

Lot Numbers:
codes
Product: 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 d

Lot codes: 40179030 3067904 3067902 3057925 3057924 3047934 3047929

Lot Numbers:
codes
Product: 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 dialysa

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

Lot Numbers:
code
Product: 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

Lot codes: 40179026 3057901 3047930

Lot Numbers:
codes
Product: 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 dialys

Lot codes: 31279092 3047917 3047916

Lot Numbers:
codes
Product: 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 dialys

Lot code: 40179126 40179125 40179108 40179036 40179035 31279119 3057923 3057907 3047927

Lot Numbers:
code
Product: 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

Lot code: 40179074

Lot Numbers:
code

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 68354
Status: Resolved
Manufacturer: NxStage Medical, Inc.
Manufactured In: United States
Units Affected: 8 products (13474 cases; 19423 cases; 5488 cases; 16,625 cases; 2839 cases; 2711 cases; 8683 cases; 91 cases)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.