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Recall Observatory FDA recall evidence

Device 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).

Z-0210-2024

September 19, 2023

Class II

Product summary

Firm
Maquet Cardiovascular, LLC
Event
Event 93297
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-0210-2024

Official wording

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

Code information: UDI-DI: 00607567700239, Lot: 3000313857.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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