Recall Z-0488-2024 ยท LSZ Ventilator, High Frequency
Vyaire Medical
vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
| Date | Dec 5, 2023 (initiated Oct 27, 2023) |
| Status | Completed |
| 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. |
| Root cause | Process control |
| Action | Vyaire issued a Customer Notification to its consignees on 10/27/2023 via email. The notice explained the issue and how to identify the affected products. The firm is seeking the return of the circuits. |
| Quantity | 188 circuits |
| Distribution | US: Florida |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.