Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow Recalled by NxStage Medical, Inc. Due to SAK Dialysate Concentrate contain aluminum levels which exceed...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact NxStage Medical, Inc. directly.
Affected Products
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.
Quantity: 19423 cases
Why Was This Recalled?
SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About NxStage Medical, Inc.
NxStage Medical, Inc. has 29 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report