BEUDAMED
    FDA Enforcement Class II Ongoing

    Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB841. Used in Cardiopulmonary bypass.

    Recall: Z-1026-2023 · Reported February 8, 2023

    Enforcement

    Recall Number
    Z-1026-2023
    Event ID
    91343
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic Perfusion Systems
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 8, 2023
    Initiation Date
    December 12, 2022
    Classification Date
    January 27, 2023
    Address
    7611 Northland Dr N, N/A, Brooklyn Park, MN, 55428-1088, United States

    Description

    Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB841. Used in Cardiopulmonary bypass.

    Reason

    An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling the perfusion circuit.

    Code Info

    Model CB841; Serial Number Range: 8111483548 - 8113999999; GTIN Number: 00763000225452 (Lot Numbers: 13394614, 13395228, 223819363, 223952969, 224315522, 224448403, 224772847, 224772848, 224772849); GTIN Number: 00763000225469 (Lot Numbers: 13392615, 13394868, 223476442, 223755429, 223796291, 223834097, 223834098, 224174020, 224188890, 224365018, 224419842, 224816179, 225222080, 225273494, 225273495, 225331432, 225332504, 225332505, 225332506, 225332508, 225661147)

    Distribution

    Worldwide distribution. US Nationwide, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Belgium, Plurinational State of Bolivia, Bosnia And Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Ethiopia, Finland, France, Germany, Ghana, Greece, Guatemala, Honduras, Hungary, Iceland, Indonesia, Islamic Republic of Iran, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Kuwait, Kyrgyzstan, Latvia, Lithuania, Luxembourg, Malaysia, Mexico, Namibia, Netherlands, New Zealand, Nigeria, North Macedonia, Norway, Oman, Pakistan, Paraguay, Philippines, Poland, Portugal, Romania, Russian Federation, Rwanda, Saudi Arabia, Slovenia, South Africa, Spain, Suriname, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Turkey, Turkmenistan, Uganda, United Arab Emirates, United Kingdom, Uruguay, Viet Nam, and Yemen.

    Quantity

    4,462 units