BEUDAMED
    FDA Enforcement Class II Ongoing

    VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System, Model Number C-VH-3500

    Recall: Z-1335-2023 · Reported April 12, 2023

    Enforcement

    Recall Number
    Z-1335-2023
    Event ID
    91764
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Maquet Cardiovascular, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 12, 2023
    Initiation Date
    March 6, 2023
    Classification Date
    April 4, 2023
    Address
    45 Barbour Pond Dr, Wayne, NJ, 07470-2094, United States

    Description

    VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System, Model Number C-VH-3500

    Reason

    Some batches of product were not sterilized to their minimum sterilization specification.

    Code Info

    UDI-DI: 00607567701250; Lot Numbers: 3000280189, 3000276183

    Distribution

    Worldwide distribution - US Nationwide and the countries of Brazil, China.

    Quantity

    900 units