BEUDAMED
    FDA Enforcement Class II Ongoing

    Vasoshield Syringe Packs, Model VH-5001

    Recall: Z-0996-2023 · Reported January 25, 2023

    Enforcement

    Recall Number
    Z-0996-2023
    Event ID
    91363
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Maquet Cardiovascular, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 25, 2023
    Initiation Date
    December 22, 2022
    Classification Date
    January 19, 2023
    Address
    45 Barbour Pond Dr, N/A, Wayne, NJ, 07470-2094, United States

    Description

    Vasoshield Syringe Packs, Model VH-5001

    Reason

    Ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonable risk of harm to the patient. Potential harms may include foreign body reaction, coronary embolic event, and peripheral embolic event.

    Code Info

    UDI-DI: 00607567700468; Serial Numbers: 25147126, 25151632, 25152389, 25152964, 25163138, 25162077

    Distribution

    US Nationwide. Japan, Germany.

    Quantity

    530 units US, 215 units OUS