FDA-Device2023-11-08Class II
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).
Maquet Cardiovascular, LLC
Hazard
Device packaged inside an incorrect outer box; displaying artwork & illustrations for a different device.
Sold states
US (AL, AR, CA, FL, GA, IN, KY, MI, NJ, OK, PA, TN, TX) and Canada.
Affected count
N/A
Manufactured in
45 Barbour Pond Dr, N/A, Wayne, NJ, United States
Products
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).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0210-2024Don't want to check this manually?
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