Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adu...
FDA Recall #Z-0551-2022 — Class II — December 23, 2021
Product Description
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)
Recalling Firm
Olympus Corporation of the Americas — Center Valley, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
35 units
Distribution
US Nationwide distribution in the states of AZ, CA, MA, NJ, PA, SC, TX, WI.
Code Information
Lot Number: WS147887-01 UDI: 896506002309 Expiration Date: 4/30/2024
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated