Madison, WI, US · 4 510(k) clearances · 1 recalls (1 Class I)
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| MRN | — | — | — | 4 | 2025-01-03 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2023-08-08 | Class I | Ongoing | Z-2450-2023 | Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators. | — | The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen. |