Product Safety Recalls

Product Recall Tracker

Coapt LLC Recall 93137

Description: Coapt Dome Electrode, Gen2 system, cutaneous electrode

Coapt LLC Recall 93137 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0203-2024
Event ID93137
Event DescriptionCoapt Dome Electrode, Gen2 system, cutaneous electrode
Product TypeDevices
DistributionWorldwide distribution - US Nationwide and the country of Sweden.
Quantity247 devices
Recall ReasonPatient 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.
Device Classification20231108
Device Code InfoUDI/DI +B618E0/$+201907E00256B, all Gen2 system serial number
Center Classification Date20231031
Recall Initiation Date20231002
Recalling FirmCoapt LLC
Initial Notification E-Mail
Similar To

© 2022 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied. is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.