BEUDAMED
    FDA Enforcement Class II Ongoing

    Gentell Honey Hydrogel Hydrogel 4oz. Tube. Wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11340 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers, first and second-degree burns, post-surgical incisions, cuts and abrasions.

    Recall: Z-1910-2020 · Reported May 13, 2020

    Enforcement

    Recall Number
    Z-1910-2020
    Event ID
    85373
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Gentell, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 13, 2020
    Initiation Date
    March 26, 2020
    Classification Date
    May 6, 2020
    Address
    2701 Bartram Rd, N/A, Bristol, PA, 19007-6810, United States

    Description

    Gentell Honey Hydrogel Hydrogel 4oz. Tube. Wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11340 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers, first and second-degree burns, post-surgical incisions, cuts and abrasions.

    Reason

    During an FDA audit, it was discovered that the product was not properly registered with FDA.

    Code Info

    Lot Numbers: 1133718 1135318 1101019 1105819 1107119 1110619 1118219 1121119 1122119 1130319

    Distribution

    Worldwide distribution - US Nationwide distributions and the country of South Africa.

    Quantity

    4,419