BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1310-2023 · Initiated February 24, 2023

    Recall

    Recall Number
    Z-1310-2023
    Event Number
    91846
    Firm
    Iradimed Corporation
    FEI Number
    3005053560
    Product Code
    FRN
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    February 24, 2023
    Posted
    March 30, 2023
    Address
    1025 Willa Springs Dr, Winter Springs, FL, 32708-5235

    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.

    Action

    Iradimed Corporation issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 02/24/2023 by certified mail. The notice explained the issue and the risk and provided updated instructions for use to mitigate the potential risk of inlet occlusion. For further information concerning this issue or have any questions, please contact Iradimed support via email at [email protected] or via telephone at 407-677-8022.

    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