Coapt Dome Electrode, Gen2 system, cutaneous electrode
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI/DI +B618E0/$+201907E00256B, all Gen2 system serial number
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Coapt LLC
- Reason for Recall:
- Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Coapt Dome Electrode, Gen2 system, cutaneous electrode
Product Codes/Lot Numbers:
UDI/DI +B618E0/$+201907E00256B, all Gen2 system serial number
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0203-2024
Related Recalls
Class I - Dangerous
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.