Class II — Potential Health Hazard

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

DeRoyal CARDIAC CATH SET-UP KIT PGYBK Recalled by DeRoyal Industries Inc Due to Kit were manufactured and distributed with Edwards Life...

Date: November 22, 2023
Company: DeRoyal Industries Inc
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 DeRoyal Industries Inc directly.

Affected Products

DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572

Quantity: 252 units

Why Was This Recalled?

Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences.

Where Was This Sold?

US: Virginia

About DeRoyal Industries Inc

DeRoyal Industries Inc has 225 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report