Lissieu, FR · 3 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| KDL | — | — | — | 2 | 2022-06-14 |
| KDN | System, Perfusion, Kidney | Class II | Gastroenterology, Urology | 1 | 2021-10-15 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-03-13 | Class II | Ongoing | Z-2220-2025 | Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/Catalog Number: 533682 Pr… | — | The potential for risk of microbiological contamination of products due to inability to ensure sterility assurance throughout aseptic manufacturing. |