Recall Z-0489-2024— Vyaire Medical

Name: FDA recall Z-0489-2024
Creator: U.S. Food and Drug Administration
Published: 2023-10-27

Class II · Completed

Class II FDA medical device recall by Vyaire Medical, initiated 2023-10-27. FDA's recall record names no specific 510(k) clearance for this event. Product: vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV). Reason: 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..

Recalling firm: Vyaire Medical
Classification: Class II
Status: Completed
Initiated: 2023-10-27
Firm location: Mettawa, IL, United States

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.