FDAFDA · Food and drugs·Recall number Z-0203-2024
Coapt Dome Electrode, Gen2 system, cutaneous electrode
Published November 8, 2023 · Recall initiated: October 2, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Coapt LLC
- Distributor
- Worldwide distribution - US Nationwide and the country of Sweden.
- Lot
- UDI/DI +B618E0/$+201907E00256B, all Gen2 system serial number
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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