BEUDAMED
    FDA Enforcement Class II Ongoing

    MEDLINE procedure kits labeled as follows: 1) 20G EPI CATH SINGLE STERILE, REF EPICATH19 2) 20G EPI CATH SINGLE STERILE, REF EPICATH20

    Recall: Z-0510-2025 · Reported December 4, 2024

    Enforcement

    Recall Number
    Z-0510-2025
    Event ID
    95615
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 4, 2024
    Initiation Date
    October 16, 2024
    Classification Date
    November 22, 2024
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    MEDLINE procedure kits labeled as follows: 1) 20G EPI CATH SINGLE STERILE, REF EPICATH19 2) 20G EPI CATH SINGLE STERILE, REF EPICATH20

    Reason

    The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

    Code Info

    Codes: 1) EPICATH19, UDI/DI 10889942358311(each) 40889942358312(case), Lot Numbers: 22FBX111, 22FBY472, 23FBT886, 23GBL403, 23GBO700, 23GBO701, 23GBO702; 2) EPICATH20, UDI-DI: 10889942358328 (each) 40889942358329 (case), Lot Numbers: 22FBN457, 22HBM699, 22HBN345, 23CBF321, 23DBM670, 23FBK248, 23GBO703, 23GBO704 23GBO705, 23KBG553, 23KBS111

    Distribution

    US Nationwide. Bermuda, Canada, Panama, UAE, US Virgin Islands

    Quantity

    5975 units