FDA recall Z-0551-2022

Olympus Corporation of the Americas · Class II · device

Product

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

Reason for recall

Mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm)

Distribution

US Nationwide distribution in the states of AZ, CA, MA, NJ, PA, SC, TX, WI.

Key facts

Status: Ongoing
Initiation date: 2021-12-23
Report date: 2022-02-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0551-2022