FDA Enforcement
Class II
Ongoing
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).
Recall: Z-0210-2024
·
Reported November 8, 2023
Enforcement
- Recall Number
- Z-0210-2024
- Event ID
- 93297
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Maquet Cardiovascular, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 8, 2023
- Initiation Date
- September 19, 2023
- Classification Date
- November 2, 2023
- Address
- 45 Barbour Pond Dr, N/A, Wayne, NJ, 07470-2094, United States
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
Device packaged inside an incorrect outer box; displaying artwork & illustrations for a different device.
Code Info
UDI-DI: 00607567700239, Lot: 3000313857.
Distribution
US (AL, AR, CA, FL, GA, IN, KY, MI, NJ, OK, PA, TN, TX) and Canada.
Quantity
N/A