Class II — Potential Health Hazard

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

AMIA Automated Peritoneal Dialysis System Product Usage: It is intended Recalled by Baxter Healthcare Corporation Due to Potential for the software on Automated PD System...

Date: December 11, 2018
Company: Baxter Healthcare Corporation
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 Baxter Healthcare Corporation directly.

Affected Products

AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritoneal dialysis.

Quantity: 7,688 devices

Why Was This Recalled?

Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Baxter Healthcare Corporation

Baxter Healthcare Corporation has 401 total recalls tracked by RecallDetector.

Related Recalls

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