Class II — Potential Health Hazard

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

Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Recalled by Baxter Healthcare Corporation Due to complaints of kinked access lines observed during treatment...

Date: December 30, 2020
Company: Baxter Healthcare Corporation
Status: Ongoing
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

Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114435 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.

Quantity: 25785 devices

Why Was This Recalled?

complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.

Where Was This Sold?

Worldwide distribution.

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