Reported Aug 19, 2015 · Ongoing

Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate for Hemodialysis (liquid) Product…

Fresenius Medical Care Holdings, 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: Fresenius Medical Care Holdings, Inc. · 920 Winter St · Waltham, MA · 02451-1521

Is this the product you have?

  • Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate
  • for Hemodialysis (liquid) Product Code08-4000-LB
Lot codes and dates
  • Lots begin with
    • 15AMLB
    • 15BMLB
    • 15CMLB
Amount recalled
2,264,028

Where it was sold

  • Nationwide

Why it was recalled

Expansion of recall to lots manufactured in 2015 due to the potential for bacterial contamination.

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

Data as of Sep 19, 5:28 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.