BEUDAMED
    FDA Enforcement Class II Ongoing

    VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000

    Recall: Z-1336-2023 · Reported April 12, 2023

    Enforcement

    Recall Number
    Z-1336-2023
    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 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000

    Reason

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

    Code Info

    UDI-DI: 00607567700406; Lot Numbers: 3000278401, 3000271148, 3000268643, 3000263026, 3000274504, 3000263925

    Distribution

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

    Quantity

    2300 units