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Class 2 Device Recall DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC |
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Date Initiated by Firm |
September 30, 2015 |
Date Posted |
June 22, 2017 |
Recall Status1 |
Terminated 3 on September 01, 2017 |
Recall Number |
Z-2731-2017 |
Recall Event ID |
77534 |
Product Classification |
Dressing,wound,hydrogel w/out drug and/or biologic - Product Code NAE
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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. |
Code Information |
Lot/Batch#1150, 1152, 5210; Expiration date: Jul.2018 (for lot 5210), July 2020 (for lot 1150, 1152) |
Recalling Firm/ Manufacturer |
O-Two Medical Technologies, Inc. 7575 Kimbel Street Mississauga Canada
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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.
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FDA Determined Cause 2 |
Process control |
Action |
O-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 Commerce |
624 units |
Distribution |
Worldwide Distribution - US (nationwide) Canada, Belgium, Norway, and Malaysia |
Total Product Life Cycle |
TPLC Device Report
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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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