Reported Jul 2, 2014 · Terminated

NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-407 Lactate 40, Potassium 1, Sodium…

NxStage Medical, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: NxStage Medical, Inc. · 350 Merrimack Street · Lawrence, MA · 01843-1748

Is this the product you have?

  • 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 codes and dates
  • Lot code40179074
Amount recalled
91 cases

This recall covers 8 products

The agency filed one notice per product. You are reading one of them; the other 7 are below.

Where it was sold

  • Nationwide

Why it was recalled

SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 13, 2017 · Data as of Sep 19, 5:31 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.