Louisville, KY, US · 1 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| KPO | — | — | — | 1 | 2020-01-22 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2022-07-26 | Class II | Terminated | Z-1739-2022 | Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with re… | — | Acidified Concentrate Distribution System potential electrical safety hazard may result in electric shock, arching |
| 2022-04-28 | Class II | Ongoing | Z-1360-2022 | Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) | — | Isopure received a report of a hazardous incident involving a device which had experienced an electrical short that resulted in a thermal event, damaging some o… |