BEUDAMED
    FDA Recall Open, Classified

    Medline Adult Anesthesia Set, REF DYNJ39985G

    Recall: Z-0137-2026 · Initiated September 10, 2025

    Recall

    Recall Number
    Z-0137-2026
    Event Number
    97650
    FEI Number
    1417592
    Product Code
    LRO
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    September 10, 2025
    Posted
    October 10, 2025
    Address
    3 Lakes Dr, Medline Industries, LP, Northfield, IL, 60093-2753

    Description

    Medline Adult Anesthesia Set, REF DYNJ39985G

    Reason

    Specific items and lots of Medline Kits may contain Clearlink IV Sets which Baxter recalled due to customer reports of leaking.

    Action

    Medline issue an UREGNE MEDICAL DEVICE NOTICE to its consignees on 9/10/2025 via email. The notice explained the issue, potential risk and requested the following: "REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. Website link: https://recalls.medline.com Recall Reference #: R-25-193-FGX1 Recall Code: 3. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. 4. If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected]."

    Distribution

    US Nationwide distribution in the states of MO.

    Quantity

    950 units