BEUDAMED
    FDA Enforcement Class II Terminated

    Burn Relief¿, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200 --- DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC. --- Burn Relief¿ products are self-cooling, non-adhering and are intended to be used on 1st and 2nd degree burns.

    Recall: Z-2731-2017 · Reported July 19, 2017

    Enforcement

    Recall Number
    Z-2731-2017
    Event ID
    77534
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    O-Two Medical Technologies, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 19, 2017
    Initiation Date
    September 30, 2015
    Classification Date
    July 13, 2017
    Termination Date
    September 1, 2017
    Address
    7575 Kimbel Street, Mississauga, N/A, Canada

    Description

    Burn Relief¿, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200 --- DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC. --- Burn Relief¿ products are self-cooling, non-adhering and are intended to be used on 1st and 2nd degree burns.

    Reason

    For lack of evidence to validate effectiveness of sterilization dose, O-Two Medical Technologies Inc. hereby announces a voluntary medical device recall of the suspected batches of Burn Relief¿ products to prevent potential contamination. .

    Code Info

    Lot/Batch#1150, 1152, 5210; Expiration date: Jul.2018 (for lot 5210), July 2020 (for lot 1150, 1152)

    Distribution

    Worldwide Distribution - US (nationwide) Canada, Belgium, Norway, and Malaysia

    Quantity

    624 units