vyaire Flexible Patient Circuit, 3100A, REF 29028-004, 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-0489-2024
- Quantity
- 16 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 10190752155251: Lot/serial numbers: 4022993, 4160569, 4160570, 4163199, 4163200, 4165472, 4166359, 4231715, 4243198, 4253792
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.
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