Recall Z-2731-2017 ยท NAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic
O-Two Medical Technologies, Inc.
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.
| Date | Jun 22, 2017 (initiated Sep 30, 2015) |
| Status | Terminated |
| 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. . |
| Root cause | 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 | 624 units |
| Distribution | Worldwide Distribution - US (nationwide) Canada, Belgium, Norway, and Malaysia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.