FEI 3010605876
Coapt Llc
303 W. Institute Pl., Chicago, IL, US
MDR events2All time
Recalls2All time
Registered products3
Establishment typeComplaintComplaint File Establishment per 21 CFR 820.198
Registered product codes
3 product codes
Recent MDR events
2 on file
Recalls
2 on file
- Open, ClassifiedOct 31, 2023
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.
View FDA record ↗ - Open, ClassifiedOct 31, 2023
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.
View FDA record ↗
Compliance history
Matched by FEI 3010605876.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Oct 28, 2024
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Oct 28, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
2 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.100(a)Oct 28, 2024
Lack of or inadequate procedures
- 21 CFR 820.100(b)Oct 28, 2024
Documentation
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.