FDA-Device2022-02-09Class II
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
Olympus Corporation of the Americas
Hazard
Mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm)
Sold states
US Nationwide distribution in the states of AZ, CA, MA, NJ, PA, SC, TX, WI.
Affected count
35 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0551-2022Don't want to check this manually?
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