BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: IV START BOX, REF ACC010665

    Recall: Z-2044-2025 · Reported July 9, 2025

    Enforcement

    Recall Number
    Z-2044-2025
    Event ID
    97027
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 9, 2025
    Initiation Date
    May 23, 2025
    Classification Date
    June 30, 2025
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: IV START BOX, REF ACC010665

    Reason

    Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow to retract or fails to retract.

    Code Info

    1) REF ACC010665: UDI/DI 10195327334918 (each), 40195327334919 (case), Lot Number 24LDA590

    Distribution

    US Nationwide distribution in the states of IN, KY, CA, MI, TX, WA.

    Quantity

    36 units