FDAFDA · Food and drugs·Recall number Z-0489-2024
vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
Published December 13, 2023 · Recall initiated: October 27, 2023
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Vyaire Medical
- Distributor
- US: Florida
- Lot
- UDI/DI 10190752155251: Lot/serial numbers: 4022993, 4160569, 4160570, 4163199, 4163200, 4165472, 4166359, 4231715, 4243198, 4253792
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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