Device evidence

device-recall:cfres:204026

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

Official recall number

Z-0489-2024

Evidence summary

Product code: LSZ
Recall status: Completed
Event initiated: October 27, 2023
Root cause: Process control
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-0489-2024