FDASeptember 30, 2015device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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. .
What to do
FDA enforcement status: Terminated
Brands named
o two medical technologies
Recall history
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