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U.S. Department of Health and Human Services

Class 2 Device Recall DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC

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 Class 2 Device Recall DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGICsee related information
Date Initiated by FirmSeptember 30, 2015
Date PostedJune 22, 2017
Recall Status1 Terminated 3 on September 01, 2017
Recall NumberZ-2731-2017
Recall Event ID 77534
Product Classification Dressing,wound,hydrogel w/out drug and/or biologic - Product Code NAE
ProductBurn 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.
Code Information Lot/Batch#1150, 1152, 5210;  Expiration date: Jul.2018 (for lot 5210), July 2020 (for lot 1150, 1152) 
FEI Number 3002807836
Recalling Firm/
Manufacturer		 O-Two Medical Technologies, Inc.
7575 Kimbel Street
Mississauga Canada
Manufacturer 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. .
FDA Determined
Cause 2		Process control
ActionO-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 cs@otwo.com. Customers with questions should call 1-905-677-9410. For questions regarding this recall call 905-677-9410 .
Quantity in Commerce624 units
DistributionWorldwide Distribution - US (nationwide) Canada, Belgium, Norway, and Malaysia
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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