BEUDAMED
    FDA Enforcement Class II Ongoing

    Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.

    Recall: Z-2193-2025 · Reported August 6, 2025

    Enforcement

    Recall Number
    Z-2193-2025
    Event ID
    97097
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Maquet Cardiopulmonary Gmbh
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 6, 2025
    Initiation Date
    June 27, 2025
    Classification Date
    July 29, 2025
    Address
    Kehler Str. 31, Rastatt, N/A, Germany

    Description

    Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.

    Reason

    Device does not comply with the labeling requirements of international standard IEC 60601-1.

    Code Info

    Model No. 701033599; UDI: 4037691257860.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Australia, New Zealand, Canada, Hong Kong, India, Israel, Japan, Singapore, South Korea, Taiwan, Thailand, Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Serbia, Slovakia, Slovenia, Spain, Sweden, Turkey, Reunion, Romania, Russian Federation, Switzerland, Ukraine, United Kingdom, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Mexico, Paraguay, Peru, Uruguay, Bahrain, Egypt, Iran, Iraq, Jordan, Kuwait, Lebanon, Oman, Pakistan, Qatar, Saudi Arabia, South Africa, United Arab Emirates, Yemen.

    Quantity

    7,754 units