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 Dry Bicarbonate Concentrate is composed of sodium bicarbonate powder Recalled by Fresenius Medical Care Holdings, Inc. Due to Exposed to freezing temperatures due to refrigerated truck...

Date: April 28, 2021
Company: Fresenius Medical Care Holdings, Inc.
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 Holdings, Inc. directly.

Affected Products

NaturaLyte Dry Bicarbonate Concentrate is composed of sodium bicarbonate powder and is used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. NaturaLyte Dry Bicarbonate Concentrate is formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osmotic gradient across the dialyzer membrane to exchange solutes with blood during hemodialysis.

Quantity: 120 Bags

Why Was This Recalled?

Exposed to freezing temperatures due to refrigerated truck malfunctions

Where Was This Sold?

This product was distributed to 1 state: TX

Affected (1 state)Not affected

About Fresenius Medical Care Holdings, Inc.

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

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