BEUDAMED
    FDA Recall Open, Classified

    Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: CDS984076J GYN ROBOTIC DYNJG001004A LAVH MINOR DYNJG901001B CRANIOTOMY DYNJ908819B KIT CRANIOTOMY (only units from SKU DYNJG001004A LAVH MINOR were distributed)

    Recall: Z-2479-2025 · Initiated July 23, 2025

    Recall

    Recall Number
    Z-2479-2025
    Event Number
    97388
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    FDE
    Status
    Open, Classified
    Root Cause
    Error in labeling
    Initiated
    July 23, 2025
    Posted
    August 28, 2025
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    Description

    Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: CDS984076J GYN ROBOTIC DYNJG001004A LAVH MINOR DYNJG901001B CRANIOTOMY DYNJ908819B KIT CRANIOTOMY (only units from SKU DYNJG001004A LAVH MINOR were distributed)

    Reason

    Kits contain SureStep Foley Tray Systems recalled by BD that include incorrect product information insert sheets. If a mislabeled tray is used, patient risk ranges from minor injury to injury that requires medical intervention, such as infection or local/systemic allergic reaction (anaphylaxis).

    Action

    Firm notified customers via email and first-class mail of the action. Medline Industries LP instructed customers to request stickers to over-label the affected convenience kits with a warning label indicating to remove the affected component and replace it with product from supply. No kits are to be returned.

    Distribution

    Domestic distribution to FL and IL. No OUS distribution reported.

    Quantity

    4 ea