FDA recall Z-0489-2024

Product

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.

Distribution

US: Florida

Key facts

Status

Completed

Initiation date

2023-10-27

Report date

2023-12-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mettawa, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0489-2024