Seattle, WA, US · 4 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Class II | Clinical Chemistry | 3 | 2025-09-25 |
| FPA | — | — | — | 1 | 2020-10-08 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2021-11-02 | Class II | Terminated | Z-0318-2022 | The Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN / Steripath Gen2 Blood Collection Sys… | — | Due to an uptick of complaints associated with premature needle retraction of blood collection system. |
| 2021-08-02 | Class II | Terminated | Z-2393-2021 | Steripath Luer Transport Pack, Gen2, Luer, BD - Product Usage: This holder/adapter assembly may be used for the access o… | — | Product was shipped with the incorrect Transfer Adapter Instructions For Use (IFU). |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-09-25 | K251812 | Steripath® Flow Blood Collection System | JKA | Class II | Clinical Chemistry |
| 2022-11-30 | K222299 | Steripath Micro Blood Collection System | JKA | Class II | Clinical Chemistry |
| 2020-10-08 | K200661 | Steripath Micro Blood Collection System | FPA | — | — |
| 2020-02-28 | K192247 | Steripath Gen2 Blood Collection System | JKA | Class II | Clinical Chemistry |