BEUDAMED
    FDA Enforcement Class II Ongoing

    MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515) and 3.5oz tube (Model Number 31535)

    Recall: Z-0054-2025 · Reported October 16, 2024

    Enforcement

    Recall Number
    Z-0054-2025
    Event ID
    95397
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Integra LifeSciences Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 16, 2024
    Initiation Date
    September 13, 2024
    Classification Date
    October 10, 2024
    Address
    1100 Campus Rd, Princeton, NJ, 08540-6650, United States

    Description

    MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515) and 3.5oz tube (Model Number 31535)

    Reason

    There is a potential for pinholes in the applicator pouch film which creates a sterility concern.

    Code Info

    Model 31515 UDI-DI: 10381780486824; Model 31535 UDI-DI: 10381780486831; All lots distributed from 12/17/2020 to 07/22/2024 with expiration dates 08/01/2024 to 06/01/2028.

    Distribution

    Worldwide - US Nationwide distribution in the states of MN, IL, UT, FL, NC, CA, MO, IN, MS, OH, PA, TX, HI, MA, WA, GA, AZ, VA, NY, CO, MI, OK, NV, NJ, SC, OR, VT, DC, WI, TN, WV, KS, AL, NE, MD, ID, LA, AR, KY, IA, AK, NM, ME, RI and the countries of Madagascar, Malaysia, Guam.

    Quantity

    120124 units