BEUDAMED
    FDA Enforcement Class II Ongoing

    Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50,

    Recall: Z-1310-2023 · Reported April 5, 2023

    Enforcement

    Recall Number
    Z-1310-2023
    Event ID
    91846
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Iradimed Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 5, 2023
    Initiation Date
    February 24, 2023
    Classification Date
    March 30, 2023
    Address
    1025 Willa Springs Dr, N/A, Winter Springs, FL, 32708-5235, United States

    Description

    Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50,

    Reason

    Certain Iradimed 1057 Syringe Adapter Sets, used with the MRidium MRI infusion pump, have a problem relating to a defective injection molded part which can limit the effectiveness of the syringe venting function which then can result in occlusion.

    Code Info

    UDI di 10856038001048, Lot Numbers: 21K50N, exp. 11/30/2023; 22A03N, exp. 01/31/2024; 22A59N, exp. 2/29/2024; 22B54N, exp. 2/29/2024; 22D15N, exp. 4/30/2024; 22D28N, exp. 4/30/2024; 22D58N, exp. 4/30/2024; 22I17N, exp. 9/30/2024; 031851, exp. 9/30/2024; 22J46N, exp. 10/31/2024; 032198, exp. 11/30/2024; 22L02N,exp. 12/31/2024; 032822, exp. 1/31/2025

    Distribution

    Worldwide distribution - US Nationwide and the countries of Austria, Canada, Chile, Denmark, Germany, Great Britain, Hong Kong, Indonesia, Italy, Korea, Kuwait, Malaysia, Netherlands, Nicaragua, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Romania, Serbia, Singapore, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, United Arab Emirates.

    Quantity

    3285 boxes of 50 devices