Coapt LLC recalls Coapt ControlSeal Electrode, cutaneous EMG Electrode

Recall date

October 2, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0204-2024

FDA classification

Class II

Brand / firm

Coapt LLC

Sold / distributed

Worldwide distribution - US Nationwide and the countries of Australia, Canada, and Sweden.

Why it was recalled

Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Coapt ControlSeal Electrode, cutaneous EMG Electrode