Class II — Potential Health Hazard

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

Automated peritoneal dialysis (APD) cycler Recalled by Baxter Healthcare Corp. Due to Baxter Healthcare Corporation is sending this communication to...

Date: February 16, 2016
Company: Baxter Healthcare Corp.
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 Corp. directly.

Affected Products

Automated peritoneal dialysis (APD) cycler

Quantity: 10 units

Why Was This Recalled?

Baxter Healthcare Corporation is sending this communication to inform you of incomplete instructions in the AMIA Automated Peritoneal Dialysis (PO) System Clinician Guide for calculating the total recommended solution therapy volume. Specifically, the instructions do not specify the need for an extra 200 mL of PD solution in order to prime the patient line and for air purge operations. The tot

Where Was This Sold?

This product was distributed to 1 state: NY

Affected (1 state)Not affected

About Baxter Healthcare Corp.

Baxter Healthcare Corp. has 126 total recalls tracked by RecallDetector.

Related Recalls

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