Z-0204-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 8, 2023
- Initiation Date
- October 2, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 109 devices
Product Description
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 Pattern
Worldwide distribution - US Nationwide and the countries of Australia, Canada, and Sweden.
Code Information
UDI/DI: +B618P1/$+202210P1603, All serial numbers