BEUDAMED
    FDA Enforcement Class II Ongoing

    Gentell Hydrogel Ag 2x2, model no GEN-11220 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin tears. It provides a moist wound environment for healing.

    Recall: Z-1623-2020 · Reported April 8, 2020

    Enforcement

    Recall Number
    Z-1623-2020
    Event ID
    85034
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Gentell, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 8, 2020
    Initiation Date
    February 27, 2020
    Classification Date
    April 1, 2020
    Address
    2701 Bartram Rd, N/A, Bristol, PA, 19007-6810, United States

    Description

    Gentell Hydrogel Ag 2x2, model no GEN-11220 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin tears. It provides a moist wound environment for healing.

    Reason

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

    Code Info

    1134117 1101918 1107518 1114918 1121118 1127718 1131018 1133218 1135118 1105919 1118819 1121419 1124919

    Distribution

    Worldwide distribution  US Nationwide distribution in the states of AL, CA, FL, IA, IL, KY, MA, MI, MN, NC, NJ, NY, OH, OK, PA, Puerto Rico, RI, SC, TN, TX, WI and countries of Panama, South Africa, Bahrain, Spain, Mexico, Costa Rica, Romania.

    Quantity

    53,134