Vyaire Medical Recall 93332
Description: vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
Vyaire Medical Recall 93332 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0489-2024 |
| Event ID | 93332 |
| Event Description | vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV) |
| Product Type | Devices |
| Distribution | US: Florida |
| Quantity | 16 circuits |
| Recall Reason | Two patient circuits, 29028-003 and 29028-004, for the 3100 High Frequency Oscillatory ventilator that are only approved for use outside the U.S. were distributed in the U.S. |
| Device Classification | 20231213 |
| Device Code Info | UDI/DI 10190752155251: Lot/serial numbers: 4022993, 4160569, 4160570, 4163199, 4163200, 4165472, 4166359, 4231715, 4243198, 4253792 |
| Center Classification Date | 20231205 |
| Recall Initiation Date | 20231027 |
| Recalling Firm | Vyaire Medical |
| Initial Notification | |
| Similar To |