BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: CORFLO Product Name: CORFLO Safety PEG Kit Model/Catalog Number: 30-5320

    Recall: Z-2334-2026 · Reported June 17, 2026

    Enforcement

    Recall Number
    Z-2334-2026
    Event ID
    98907
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Avanos Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    June 17, 2026
    Initiation Date
    April 30, 2026
    Classification Date
    June 5, 2026
    Address
    5405 Windward Pkwy, N/A, Alpharetta, GA, 30004-4667, United States

    Description

    Brand Name: CORFLO Product Name: CORFLO Safety PEG Kit Model/Catalog Number: 30-5320

    Reason

    Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

    Code Info

    UDI-DI 10350770007554, Lot Numbers 30365227, 30368642, 30374529, 30376099, 30380696, and 30387248

    Distribution

    US Nationwide distribution.

    Quantity

    61 kits