Device product
vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
Z-0489-2024
Product summary
- Firm
- Vyaire Medical
- Event
- Event 93332
- Status
- Completed
- Classification
- Class II
- Quantity
- 16 circuits
- Official record key
device-enforcement:Z-0489-2024
Official wording
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.
Code information: UDI/DI 10190752155251: Lot/serial numbers: 4022993, 4160569, 4160570, 4163199, 4163200, 4165472, 4166359, 4231715, 4243198, 4253792
Distribution pattern: US: Florida
Derived failure modes
-
Unknown
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.