Class II — Potential Health Hazard

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

Prismaflex Control Unit Recalled by Baxter Healthcare Corporation Due to Prismaflex product code 114870 does not have FDA...

Date: April 7, 2020
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

Prismaflex Control Unit

Quantity: 5 devices US territories

Why Was This Recalled?

Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distributed.

Where Was This Sold?

Distribution only to Puerto Rico and Guam

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