vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory Ven
FDA device recall Z-0488-2024 · posted 2023-12-05 · Completed
Recall details
- Recalling firm
- Vyaire Medical
- 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.
- 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.
- Root cause
- Process control
- Status
- Completed
- Product code
- LSZ
- Quantity affected
- 188 circuits
- Distribution
- US: Florida
- Date initiated
- 2023-10-27
- Date posted
- 2023-12-05
- Location
- Mettawa, IL
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