Class II — Potential Health Hazard

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

DriSate¿ Product Code DR-145 The acid concentrate powders and liquids Recalled by Rockwell Medical, Inc Due to A subassembly component (dextrose bag) within this case...

Date: April 7, 2018
Company: Rockwell Medical, 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 Rockwell Medical, Inc directly.

Affected Products

DriSate¿ Product Code DR-145 The acid concentrate powders and liquids are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/monitor and bicarbonate concentrate.

Quantity: 139

Why Was This Recalled?

A subassembly component (dextrose bag) within this case product contained small amounts of sodium bicarbonate from a prior batch.

Where Was This Sold?

This product was distributed to 1 state: NY

Affected (1 state)Not affected

About Rockwell Medical, Inc

Rockwell Medical, Inc has 1 total recall tracked by RecallDetector.

Related Recalls

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