FDA recall Z-0210-2024

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 for recall

Device packaged inside an incorrect outer box; displaying artwork & illustrations for a different device.

Distribution

US (AL, AR, CA, FL, GA, IN, KY, MI, NJ, OK, PA, TN, TX) and Canada.

Key facts

Status

Ongoing

Initiation date

2023-09-19

Report date

2023-11-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wayne, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0210-2024