Natus Warmette Blanket Cabinet and Warmette Dual Cabinet The Natus Warmette Blanket Cabinet is d...
FDA Device Recall #Z-0951-2017 — Class II — October 15, 2016
Recall Summary
| Recall Number | Z-0951-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 15, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Natus Manufacturing Limited |
| Location | GORT, Galway |
| Product Type | Devices |
| Quantity | 31 |
Product Description
Natus Warmette Blanket Cabinet and Warmette Dual Cabinet The Natus Warmette Blanket Cabinet is designed to store and warm blankets and hospital linens; while, the Natus Warmette Dual Cabinet is designed to store and warm blankets and hospital linens in one compartment and fluids (irrigation and/or injection) in the other compartment within the storage times and warming temperatures recommended by the manufacturers of those items
Reason for Recall
The fuse blows during initial power up or after a period of time. This results in a complete loss of power to the Cabinet and in some cases has resulted in the fuse cover for the power inlet melting slightly.
Distribution Pattern
Worldwide Distribution - US including NJ, NC, TX, IL, VA, NY, FL, CA, MS, WA, IN, and MA. and Internationally to Canada and Costa Rica.
Lot / Code Information
Warmette Blanket Cabinet Serial Numbers: 10216709, 10216711, 10218559, 10219214, 10219337, 10219338, 10219339, 10219340, 10219387, 10219388, 10219869, 10219870, 10219871, 10219872, 10219873, 1028880. Warmette Dual Cabinet Serial Numbers: 10216713, 10216714, 10218500, 10218501, 10218522, 10218526, 10218528, 10218982, 10219257, 10219389, 10219390, 10220534, 10220536, 10220537, 10220538.
Other Recalls from Natus Manufacturing Limited
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1143-2021 | Class II | Ref: NT821731C, Natus EDS 3 CSF External Draina... | Jan 12, 2021 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
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.