Burn Relief¿, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s): 06BK1221, 06BK123...
FDA Device Recall #Z-2731-2017 — Class II — September 30, 2015
Recall Summary
| Recall Number | Z-2731-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 30, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | O-Two Medical Technologies, Inc. |
| Location | Mississauga |
| Product Type | Devices |
| Quantity | 624 units |
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. .
Distribution Pattern
Worldwide Distribution - US (nationwide) Canada, Belgium, Norway, and Malaysia
Lot / Code Information
Lot/Batch#1150, 1152, 5210; Expiration date: Jul.2018 (for lot 5210), July 2020 (for lot 1150, 1152)
Other Recalls from O-Two Medical Technologies, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0978-2019 | Class I | e700 Automatic Transport Ventilator, Model Num... | Feb 12, 2019 |
| Z-0977-2019 | Class I | e600 Automatic Transport Ventilator, Model Num... | Feb 12, 2019 |
| Z-0976-2019 | Class I | e500 Automatic Transport Ventilator, Model Num... | Feb 12, 2019 |
| Z-2885-2018 | Class II | O-Two Equinox¿ Relieve N2O/O2 Analgesic Gas Mix... | May 14, 2018 |
| Z-2705-2017 | Class II | O-Two Adult Ventilation Timer, MODEL #(s): 01B... | Jun 23, 2015 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.