O-Two Medical Technologies, Inc. recalls Burn Relief¿, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200…

Recall date

September 30, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2731-2017

FDA classification

Class II

Brand / firm

O-Two Medical Technologies, Inc.

Sold / distributed

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

Why it was recalled

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. .

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.