Recall Z-0210-2024— Maquet Cardiovascular, LLC
Class II · Ongoing
Class II FDA medical device recall by Maquet Cardiovascular, LLC, initiated 2023-09-19. It names one FDA 510(k) clearance: K091733. 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).. Reason: Device packaged inside an incorrect outer box; displaying artwork & illustrations for a different device..
- Recalling firm
- Maquet Cardiovascular, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-09-19
- Firm location
- Wayne, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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).
Reason for recall
Device packaged inside an incorrect outer box; displaying artwork & illustrations for a different device.
Data sourced from openFDA. This site is unofficial and independent of the FDA.