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FDAOctober 27, 2023device

vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)

Official recall recorded by the U.S. Food & Drug Administration.

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

FDA enforcement status: Completed

Brands named

vyaire medicalvyaire

UPCs

10190752155251

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV) — Recall Details · AllClear