Netanya, IL · 1 510(k) clearances · 1 recalls (1 Class I)
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| FRN | Pump, Infusion | Class II | General Hospital | 1 | 2023-03-10 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2023-09-11 | Class I | Ongoing | Z-0094-2024 | Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF… | — | Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism. |