Class II — Potential Health Hazard

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

Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat chronic Recalled by Baxter Healthcare Corporation Due to Potential for Internal Blood Leaks due to a...

Date: November 23, 2022
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

Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat chronic and acute renal failure by hemodialysis.

Quantity: 3,610,944 units

Why Was This Recalled?

Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer

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