Molift 2-Point sling bar, an accessory for Molift Mover 205. Item nos. 1430016 1430017 1430021
FDA Device Recall #Z-1351-2019 — Class II — February 4, 2019
Recall Summary
| Recall Number | Z-1351-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 4, 2019 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Moller Vital |
| Location | Gjovik |
| Product Type | Devices |
| Quantity | 427 total |
Product Description
Molift 2-Point sling bar, an accessory for Molift Mover 205. Item nos. 1430016 1430017 1430021
Reason for Recall
The firm has received 7 reports of malfunction for the device in which the hooks have broken off, potentially leading the sling to slip out of the sling bar and causing the patient to fall.
Distribution Pattern
Domestic distribution to Arizona, Delaware, Florida, Georgia, Massachusetts, Ohio, South Carolina, Texas, Washington, and Wisconsin. Foreign distribution to Canada, Asia, Europe, and Australia.
Lot / Code Information
All units manufactured between May 2013 and October 2018. Date of manufacture is labeled on the product.
Other Recalls from Moller Vital
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1352-2019 | Class II | Molift 2-Point sling bar, an accessory for Moli... | Feb 4, 2019 |
| Z-2291-2016 | Class II | Molift Air 205, Molift Air 205 Propulsion, Moli... | Jun 24, 2016 |
| Z-1343-2013 | Class II | Molift Smart 150 | Feb 15, 2013 |
| Z-1342-2013 | Class II | Molift Smart 150 | Feb 15, 2013 |
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.