FDA-Device2023-12-13Class II
vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
Vyaire Medical
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.
Sold states
US: Florida
Affected count
16 circuits
Manufactured in
26125 N Riverwoods Blvd, Mettawa, IL, United States
Products
vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0489-2024Don't want to check this manually?
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