BEUDAMED
    FDA Recall Open, Classified

    Medline Convenience Kits for Various Procedures: 1) ADULT INTUBATION TRAY, Model Number DYNJAA254A; 2) ADULT MAIN DISP. INTUB PART A, Model Number DYNJAA262A

    Recall: Z-1182-2025 · Initiated January 9, 2025

    Recall

    Recall Number
    Z-1182-2025
    Event Number
    96188
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    CAI
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    January 9, 2025
    Posted
    February 19, 2025
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    Description

    Medline Convenience Kits for Various Procedures: 1) ADULT INTUBATION TRAY, Model Number DYNJAA254A; 2) ADULT MAIN DISP. INTUB PART A, Model Number DYNJAA262A

    Reason

    Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to a shorter duration that a skin barrier can effectively adhere to and protect the skin before it needs to be replaced.

    Action

    An URGENT MEDICAL DEVICE RECALL notification letter dated 1/9/25 was sent to customers. REQUIRED ACTION: 1.Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. Quarantine all affected product immediately. 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 response form. 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 the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. The login for completing the response form is: Website link: https://recalls.medline.comRecall Reference #: R-24-282-FGX1 Recall Code: Recall Code 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. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected].

    Distribution

    US States: CA, NY

    Quantity

    70 kits