Device evidence

device-recall:cfres:191288

Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with shortness of breath and hyperinflation Model Number: SVS-V9-00

Official recall number

Z-0551-2022

Evidence summary

Product code: NJK
Recall status: Open, Classified
Event initiated: December 23, 2021
Root cause: Labeling Change Control
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-0551-2022