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
Z-0551-2022
Product summary
- Event
- Event 89333
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 35 units
- Official record key
device-enforcement:Z-0551-2022
Official wording
Reason: Mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm)
Code information: Lot Number: WS147887-01 UDI: 896506002309 Expiration Date: 4/30/2024
Distribution pattern: US Nationwide distribution in the states of AZ, CA, MA, NJ, PA, SC, TX, WI.
Derived failure modes
-
Labeling or packaging
Mislabeled