First Medical Source LLC
FDA Regulatory Profile
First Medical Source LLC appears in FDA public data with 1 recall — including 1 Class I (most serious) —, 1 510(k) clearance, 3 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-0161-2013, Class I) was initiated on July 9, 2011. Its most recent 510(k) clearance was granted on November 5, 2024.
Summary
- Total Recalls
- 1 (1 Class I)
- 510(k) Clearances
- 1
- Inspections
- 3
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0161-2013 | Class I | Medpro Elastomeric Infusion Pump. AccuFlux, Model # CT-0020-100H. Product Usage: The devic | July 9, 2011 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K240624 | InfuLife | November 5, 2024 |