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 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101. For Recalled by Fresenius Medical Care Renal Therapies Group, LLC Due to Dissolution units and replacement motors units do not...

Date: October 23, 2015
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 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101. For Use in the Preparation of acid concentrate for hemodialysis.

Quantity: 918 units

Why Was This Recalled?

Dissolution units and replacement motors units do not provide full thermal protection for both the Main and Starter coils resulting in the generation of smoke and/or potentially lead to fire.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 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