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O-Two Medical Technologies, Inc. recalls Burn Relief¿, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200 -
Recalled July 19, 2017 · FDA recall Z-2731-2017 · O-Two Medical Technologies
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. . · FDA Class II
Units
624 units
Sold at
Worldwide Distribution - US (nationwide) Canada, Belgium, Norway, and Malaysia
Description
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. .
Product
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.
Manufacturer(s)
O-Two Medical Technologies, Inc.
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →