Etac Supporter toilet armrest Etac Supporter toilet armrests are foldable and have comfortable r...
FDA Device Recall #Z-2073-2015 — Class II — June 15, 2015
Recall Summary
| Recall Number | Z-2073-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 15, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Etac Supply Center Ab |
| Location | Anderstorp, N/A |
| Product Type | Devices |
| Quantity | 25 units |
Product Description
Etac Supporter toilet armrest Etac Supporter toilet armrests are foldable and have comfortable rounded grips for the hands. Supporter is simple to mount without the need for any tools. It fits both floor and wall mounted toilets. If space around the toilet is limited either armrest can easily be detached. Supporter includes seat ring and lid.
Reason for Recall
The Supporter toilet armrest has two Fast Nuts fixing the product to the toilet porcelain. The firm has reports of the two Fast Nuts coming loose and causing the Supporter to become unsteady.
Distribution Pattern
Nationwide Distribution including GA, CT and PA.
Lot / Code Information
Serial numbers higher than 224017
Other Recalls from Etac Supply Center Ab
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2381-2015 | Class II | Etac Relax wall mounted shower seat The Etac R... | Jul 12, 2015 |
| Z-1807-2013 | Class II | Swift Mobil shower chair, Swift Mobil 160 showe... | May 23, 2013 |
| Z-2014-2012 | Class II | Etac¿ Ono Walker, Etac¿ Avant Walker, and Etac... | Apr 6, 2012 |
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.