medical Class II Updated 2023-11-08

Coapt LLC recalls Coapt ControlSeal Electrode, cutaneous EMG Electrode

Recalled Product

Coapt ControlSeal Electrode, cutaneous EMG Electrode


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI/DI: +B618P1/$+202210P1603, All serial numbers
View official government recall

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