BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0887-2022 · Initiated February 9, 2022

    Recall

    Recall Number
    Z-0887-2022
    Event Number
    89744
    Firm
    Maquet Cardiovascular, LLC
    FEI Number
    2242352
    Product Code
    DWS
    Status
    Open, Classified
    Root Cause
    Mixed-up of materials/components
    Initiated
    February 9, 2022
    Address
    45 Barbour Pond Dr, Wayne, NJ, 07470-2094

    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.

    Action

    On February 14, 2022, a customer notification letter was issued via FedEx. Customers are instructed to quarantine and return all affected product and notify all users within the hospital/facility. Please note affected lot numbers appear on the device package only. If the packaging has been discarded, the affected devices can be identified by Device Component Lot number, which is etched onto all 3 device components on side of handle and on underside above each pin. Customers are to complete and return the response form by email or fax. Distributors are to forward this document to customers for appropriate action. If you have any questions, please contact your Maquet Cardiovascular, LLC /Getinge representative or call the Getinge Customer Service at (888) 880-2874, Monday through Friday, between the hours of 6:00a.m. and 5:00 p.m. (Pacific Standard Time)

    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