BEUDAMED
    FDA Recall Open, Classified

    namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722; medical convenience kit

    Recall: Z-1428-2025 · Initiated February 12, 2025

    Recall

    Recall Number
    Z-1428-2025
    Event Number
    96367
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    DRI
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    February 12, 2025
    Posted
    March 21, 2025
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    Description

    namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722; medical convenience kit

    Reason

    The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.

    Action

    Medline Industries issued two notices, delivered using email and US Mail: 1) a MEDICAL DEVICE RECALL notice for the affected Pressure Monitoring Lines and 2) a MEDICAL DEVICE RECALL notice for the kits containing the affected product; both notices explained the issue and the hazard. The MEDICAL DEVICE RECALL notice for the affected Pressure Monitoring Lines requested that the consignee destroy any affected inventory and reply to receive credit. The MEDICAL DEVICE RECALL notice for the kits containing the affected product requested the consignee respond to the notice and upon response, Medline will provide labeling that states the following: "ATTENTION This kit contains a recalled item Medline Pressure Monitoring Lines VPN: 24614303 DO NOT USE THIS COMPONENT The rest of the kit may be used. Please remove this item only and replace with product from supply. *Do not cover or remove this sticker*" Consignees were directed to notify their customers of these actions.

    Distribution

    Worldwide distribution - US Nationwide and the countries of The Netherlands, New Zealand, Slovakia

    Quantity

    4400 units