Reported Jan 20, 2021 · Ongoing

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2351-8 - 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 08-2351-8 - 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 Numbers20LXAC097
  • Additional affected lot as of 3/17/2120NXAC033
Amount recalled
577 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, 6:58 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.