vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
This recall has been completed (originally issued December 5, 2023).
- Company
- Vyaire Medical
- Recall Initiated
- October 27, 2023
- Posted
- December 5, 2023
- Recall Number
- Z-0488-2024
- Quantity
- 188 circuits
- Firm Location
- Mettawa, IL
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US: Florida
Lot / Code Info
UDI/DI 10190752159747: Lot/serial numbers: 4060467, 4165459, 4167324, 4180598, 4180599, 4180604, 4180609, 4180610, 4180611, 4182155, 4182156, 4182157, 4182158, 4182159, 4182160, 4182161, 4182162, 4182163, 4182164, 4183410, 4183411, 4188658, 4190144, 4253788, 4253789, 4180603
Root Cause
Process control
Action Taken
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.