FDA recall Z-0204-2024

Coapt LLC · Class II · device

Product

Coapt ControlSeal Electrode, cutaneous EMG Electrode

Reason for recall

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.

Distribution

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

Key facts

Status: Ongoing
Initiation date: 2023-10-02
Report date: 2023-11-08
Voluntary/Mandated: Voluntary: Firm initiated
Location: Chicago, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0204-2024