BEUDAMED
    FDA Enforcement Class II Ongoing

    Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.

    Recall: Z-0887-2022 · Reported April 13, 2022

    Enforcement

    Recall Number
    Z-0887-2022
    Event ID
    89744
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Maquet Cardiovascular, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 13, 2022
    Initiation Date
    February 9, 2022
    Classification Date
    April 6, 2022
    Address
    45 Barbour Pond Dr, Wayne, NJ, 07470-2094, United States

    Description

    Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.

    Reason

    Potential for corrosion on the pins of the Ultima Activator II Reusable Drive Mechanism. Harms may include allergic reaction, metal toxicity, and other delayed responses.

    Code Info

    UDI# 00607567700901, Lots (3): 25153700, 25157489, 25158616. Please note affected lot numbers (25153700, 25157489, 25158616) appear on the device package only. If the packaging has been discarded, the affected devices can be identified by Device Component Lot number (200501), which is etched onto all 3 device components on side of handle and on underside above each pin.

    Distribution

    Worldwide - United States (AL, AZ, CA, FL, IL, KY, LA, MO, MT, NM, OH, PA, TX, WI), Germany, Republic of Korea (South Korea), Russia, Thailand, United Arab Emirates.

    Quantity

    60