Morning Life, Model WIC2008S & WIC2008, UDI 8809293 870336 Product Usage: Intended for limb m...
FDA Device Recall #Z-0204-2018 — Class II — January 13, 2017
Recall Summary
| Recall Number | Z-0204-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 13, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Won Industry Co. |
| Location | Siheung-si, N/A |
| Product Type | Devices |
| Quantity | 2 |
Product Description
Morning Life, Model WIC2008S & WIC2008, UDI 8809293 870336 Product Usage: Intended for limb massage utilizing air compression. It is specially designed to improve venous and lymphatic circulation by compressing and releasing air pressure programmed on the device. It helps to prevent the blood blockage in cardiovascular and to relax stressed muscle by increasing the temperature of hypodermic tissue and expanding the blood vessels. It vitalizes the circulation of blood and lymph in arms, legs and waist and enhances the pressure of muscular issues to remove swelling or pain.
Reason for Recall
Distribution of unapproved devices with incorrect air compression level setup
Distribution Pattern
Worldwide distribution - US Nationwide - Domestic: MD & TX; Internationally: Mexico
Lot / Code Information
Serial numbers: EMM16100968 and EMM16100967 MFG DATE: 2016.10.10
Other Recalls from Won Industry Co.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0205-2018 | Class II | Compressible Limb Therapy System (Leg Cuffs, Ar... | Jan 13, 2017 |
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.