BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline convenience kits: CMH CENTRAL LINE DRESSING CHANGE KIT EBSI1705A CVC/PICC/MIDLINE DRESSING CHANGE KIT EBSI1057A DIALYSIS DRESSING CHANGE EBSI1498 EBSI CVC DRESSING CHANGE KIT EBSI1585 PICC DRESSING CHANGE TRAY EBSI1621 PORT ACCESS KIT EBSI1837

    Recall: Z-2438-2026 · Reported June 24, 2026

    Enforcement

    Recall Number
    Z-2438-2026
    Event ID
    98951
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medline Industries, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 24, 2026
    Initiation Date
    April 27, 2026
    Classification Date
    June 12, 2026
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    Medline convenience kits: CMH CENTRAL LINE DRESSING CHANGE KIT EBSI1705A CVC/PICC/MIDLINE DRESSING CHANGE KIT EBSI1057A DIALYSIS DRESSING CHANGE EBSI1498 EBSI CVC DRESSING CHANGE KIT EBSI1585 PICC DRESSING CHANGE TRAY EBSI1621 PORT ACCESS KIT EBSI1837

    Reason

    Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

    Code Info

    EBSI1705A UDI-DI 10653160382850 Lot 2025103090 EBSI1057A UDI-DI 10653160356875 Lot 2025120890 EBSI1498 UDI-DI 10193489111538 Lot 2025110690 EBSI1585 UDI-DI 10653160354796 Lot 2025102190 EBSI1621 UDI-DI 10653160358336 Lot 2025110390 EBSI1837 UDI-DI 10653160388555 Lot 2025102990

    Distribution

    US Nationwide distribution. OUS distribution pending.

    Quantity

    49,654 kits total