FDA Enforcement
Class II
Ongoing
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
Recall: Z-0551-2022
·
Reported February 9, 2022
Enforcement
- Recall Number
- Z-0551-2022
- Event ID
- 89333
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Olympus Corporation of the Americas
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 9, 2022
- Initiation Date
- December 23, 2021
- Classification Date
- February 1, 2022
- Address
- 3500 Corporate Pkwy, N/A, Center Valley, PA, 18034-8229, United States
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
Mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm)
Code Info
Lot Number: WS147887-01 UDI: 896506002309 Expiration Date: 4/30/2024
Distribution
US Nationwide distribution in the states of AZ, CA, MA, NJ, PA, SC, TX, WI.
Quantity
35 units