Reported Jan 20, 2021 · Ongoing

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2251-0 - Product Usage: used in conjunction with Fresenius…

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 Bld 950 · Waltham, MA · 02451-1521

Is this the product you have?

  • NaturaLyte Liquid Acid concentrate bottles
  • Model Number 08-2251-0 - Product Usageused in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine
Lot codes and dates
  • Lot Numbers
    • 20LXAC048
    • 20LXAC053
    • 20LXAC047
    • 20NXAC016
    • 20LXAC094
    • 20NXAC009
    • 20LXAC049
    • 20LXAC054
    • 20NXAC025
    • 20NXAC024
  • Additional Affected lots as of 3/17/2120LXAC076 20LXAC077 20LXAC091 20LXAC101 20NXAC010 20NXAC016
Amount recalled
11709 cases

This recall covers 30 products

The agency filed one notice per product. You are reading one of them; the other 29 are below.

17 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

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, 5:41 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.