Class II — Potential Health Hazard

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...

Date: May 14, 2014
Company: NxStage Medical, Inc.
Status: Terminated
Source: FDA (Device)

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-305 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 1 Chloride 100, Glucose (mg/dL) 100 Batch Size (liters) 40

Quantity: 2839 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.

Affected (51 states)Not affected

About NxStage Medical, Inc.

NxStage Medical, Inc. has 29 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report