Combat Medical Systems, LLC
Combat Medical Systems, LLC appears in FDA public data with 5 recalls — including 5 Class I (most serious) —, 3 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1110-2021, Class I) was initiated on December 23, 2020. Its most recent 510(k) clearance was granted on January 26, 2015.
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-1111-2021 | Class I | Valkyrie LTOWB Administration (P/N 80-821 NSN 6515016862401). Blood convenience kit. The Valkyr | 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 |