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 Blood Set Recalled by Baxter Healthcare Corporation Due to There is a potential leak between the venous...

Date: April 14, 2021
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

Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.

Quantity: 17,487 units

Why Was This Recalled?

There is a potential leak between the venous patient connector and patient's hemodialysis access.

Where Was This Sold?

Worldwide distribution - United States distribution and the countries of Canada, Korea, and Norway.

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