OptumHealth Care Solutions LLC
FDA Regulatory Profile
OptumHealth Care Solutions LLC appears in FDA public data with 1 recall — including 1 Class I (most serious) —, 1 510(k) clearance, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-1811-2024, Class I) was initiated on April 18, 2024. Its most recent 510(k) clearance was granted on October 23, 2013.
Summary
- Total Recalls
- 1 (1 Class I)
- 510(k) Clearances
- 1
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1811-2024 | Class I | Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump | April 18, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K130971 | OPTUM TELEHEALTH APPLICATION | October 23, 2013 |