BEUDAMED
    FDA Recall 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 · Initiated September 30, 2015

    Recall

    Recall Number
    Z-2731-2017
    Event Number
    77534
    Firm
    O-Two Medical Technologies, Inc.
    FEI Number
    3002807836
    Product Code
    NAE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 30, 2015
    Posted
    June 22, 2017
    Terminated
    September 1, 2017
    Address
    7575 Kimbel Street, Mississauga 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. .

    Action

    O-Two sent a Voluntary Recall Notification dated September 30, 2015, to all affected customers. Customers were instructed to acknowledge receipt of the recall notice by fax to 1-905-677-2035; or email to [email protected]. Customers with questions should call 1-905-677-9410. For questions regarding this recall call 905-677-9410 .

    Distribution

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

    Quantity

    624 units