Home / Recalls / Olympus Corporation of the Americas / Z-0551-2022

Z-0551-2022 Class II Ongoing

Recalled by Olympus Corporation of the Americas — Center Valley, PA

Recall Details

Product Type
Devices
Report Date
February 9, 2022
Initiation Date
December 23, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
35 units

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)

Distribution Pattern

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

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