BEUDAMED
    FDA Enforcement Class II Terminated

    Manuka Honey Wound Gel Catalogue No: 716597 Product Usage: Helps maintain a moist wound environment which has shown to be conducive to wound healing Ideal for minor scalds and burns, minor cuts, lacerations and minor abrasions

    Recall: Z-1630-2018 · Reported May 16, 2018

    Enforcement

    Recall Number
    Z-1630-2018
    Event ID
    79765
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Integra LifeSciences Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 16, 2018
    Initiation Date
    March 6, 2018
    Classification Date
    May 4, 2018
    Termination Date
    July 30, 2018
    Address
    311 Enterprise Dr, N/A, Plainsboro, NJ, 08536-3344, United States

    Description

    Manuka Honey Wound Gel Catalogue No: 716597 Product Usage: Helps maintain a moist wound environment which has shown to be conducive to wound healing Ideal for minor scalds and burns, minor cuts, lacerations and minor abrasions

    Reason

    Incorrect gel part number listed in a master manufacturing record

    Code Info

    Lot# 1610; 1621; 1639; 1737; 1745

    Distribution

    US state of RI

    Quantity

    766 cases