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 Capillary Dialyzer 300 Recalled by Baxter Healthcare Corporation Due to There is the potential presence of particular matter...

Date: November 15, 2019
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

Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L

Quantity: 101976 devices

Why Was This Recalled?

There is the potential presence of particular matter in the header caps of ten lots the Revaclear 300 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