Z-0210-2024 Class II Ongoing
FDA device recall Z-0210-2024 was initiated by Maquet Cardiovascular, LLC on September 19, 2023 and is designated Class II. Reason for recall: Device packaged inside an incorrect outer box; displaying artwork & illustrations for a different device. The recall status is ongoing. Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- November 8, 2023
- Initiation Date
- September 19, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
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.
Distribution Pattern
US (AL, AR, CA, FL, GA, IN, KY, MI, NJ, OK, PA, TN, TX) and Canada.
Code Information
UDI-DI: 00607567700239, Lot: 3000313857.