Device product
Vasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System, Model VH-2400 printed on outer label, inner label and IFU, outer box artwork for Vasoview Hemopro 2 (HP2).
Z-0210-2024
Product summary
- Event
- Event 93297
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-0210-2024
Official wording
Reason: Device packaged inside an incorrect outer box; displaying artwork & illustrations for a different device.
Code information: UDI-DI: 00607567700239, Lot: 3000313857.
Distribution pattern: US (AL, AR, CA, FL, GA, IN, KY, MI, NJ, OK, PA, TN, TX) and Canada.
Derived failure modes
-
Unknown
Device packaged inside an incorrect outer box; displaying artwork & illustrations for a different device.