Vyaire Medical recalls vyaire Flexible Patient Circuit, 3100A, REF 29028-004, inten
Recalled Product
vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
Hazard / Issue
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.
Issued by
FDA
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