Genesis BPS, LLC.
FDA Regulatory Profile
Genesis BPS, LLC. appears in FDA public data with 3 recalls, 1 510(k) clearance, 5 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-2669-2014, Class II) was initiated on July 17, 2014. Its most recent 510(k) clearance was granted on February 13, 2009.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 1
- Inspections
- 5
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2669-2014 | Class II | Pedi-Pak Pedi-Syringe Filter 35 mL Monoject Syringe Rx Only Genesis BPS, LLC The intended use is t | July 17, 2014 |
| Z-2667-2014 | Class II | Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson Syringe Rx Only Genesis BPS, LLC The intended | July 17, 2014 |
| Z-2668-2014 | Class II | Pedi-Pak Pedi-Syringe Filter 60 mL Becton Dickinson/Monoject Syringe Rx Only Genesis BPS, LLC The | July 17, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K082027 | FLU-ADMIN, MODELS 60150, 60150C, 60151C, 60153C, 60160 | February 13, 2009 |