Recall Z-2731-2017— O-Two Medical Technologies, Inc.
Class II · Terminated
Class II FDA medical device recall by O-Two Medical Technologies, Inc., initiated 2015-09-30, terminated 2017-09-01. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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. ..
- Recalling firm
- O-Two Medical Technologies, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-09-30
- Terminated
- 2017-09-01
- Firm location
- Mississauga, Canada
Product 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 recall
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. .
Data sourced from openFDA. This site is unofficial and independent of the FDA.