Z-0210-2024 Class II Ongoing

Recalled by Maquet Cardiovascular, LLC — Wayne, NJ

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.