Class II — Potential Health Hazard

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

Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate Recalled by Fresenius Medical Care Holdings, Inc. Due to Expansion of recall to lots manufactured in 2015...

Date: July 16, 2015
Company: Fresenius Medical Care Holdings, Inc.
Status: Ongoing
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 Holdings, Inc. directly.

Affected Products

Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate for Hemodialysis (liquid) Product Code: 08-4000-LB

Quantity: 2,264,028

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc. has 161 total recalls tracked by RecallDetector.

Related Recalls

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