Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 Intended Use: Recalled by Fresenius Medical Care Renal Therapies Group, LLC Due to On the label calcium (Ca) listed in the...

Date: January 18, 2016
Company: Fresenius Medical Care Renal Therapies Group, LLC
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 Fresenius Medical Care Renal Therapies Group, LLC directly.

Affected Products

Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 Intended Use: Acid Concentrate for Bicarbonate Dialysis

Quantity: 848 (212 cases)

Why Was This Recalled?

On the label calcium (Ca) listed in the right upper corner of the label (red background) incorrectly indicates the product contains 2.5 mEq/L Ca. The concentration indicated in the list of constituents represents the actual calcium concentration of the final dialysate, 3.0 mEq/L.

Where Was This Sold?

This product was distributed to 5 states: KS, LA, MS, OK, TX

Affected (5 states)Not affected

About Fresenius Medical Care Renal Therapies Group, LLC

Fresenius Medical Care Renal Therapies Group, LLC has 27 total recalls tracked by RecallDetector.

Related Recalls

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