Little Elm, TX, US · 1 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Class II | Clinical Chemistry | 1 | 2021-04-09 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2024-02-05 | Class II | Ongoing | Z-1293-2024 | EasyPoint Needle, 25G x 5/8", REF: 82091 | — | The needle cannula of a retractable needle may detach from the needle holder in the patient. |