vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
Reported: December 13, 2023 Initiated: October 27, 2023 #Z-0489-2024
Product Description
vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
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.
Details
- Recalling Firm
- Vyaire Medical
- Units Affected
- 16 circuits
- Distribution
- US: Florida
- Location
- Mettawa, IL
Frequently Asked Questions
What product was recalled? ▼
vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV). Recalled by Vyaire Medical. Units affected: 16 circuits.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 13, 2023. Severity: Moderate. Recall number: Z-0489-2024.
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