Combat Medical Systems, LLC
FDA Regulatory Profile
Summary
- Total Recalls
- 5 (5 Class I)
- 510(k) Clearances
- 3
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1110-2021 | Class I | Valkyrie LTOWB Collection (P/N 80-820, NSN 6515016862423). Blood collection convenience kit. Th | December 23, 2020 |
| Z-1112-2021 | Class I | Low Titer Type O FWB Transfusion Set (P/N 80-875 NSN 651501684994). Blood convenience kit. The T | December 23, 2020 |
| Z-1114-2021 | Class I | Fresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306) . Blood convenience kit. The Fresh | December 23, 2020 |
| Z-1113-2021 | Class I | Fresh Whole Blood Transfusion Set (P/N 80-801 NSN 6515016574750) . Blood convenience kit. The Fr | December 23, 2020 |
| Z-1111-2021 | Class I | Valkyrie LTOWB Administration (P/N 80-821 NSN 6515016862401). Blood convenience kit. The Valkyr | December 23, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K141685 | CROC | January 26, 2015 |
| K130482 | COMBAT READY CLAMP | April 29, 2013 |
| K102025 | COMBAT READY CLAMP | August 11, 2010 |