Etac Relax wall mounted shower seat The Etac Relax is a wall mounted shower seat designed as a s...
FDA Device Recall #Z-2381-2015 — Class II — July 12, 2015
Recall Summary
| Recall Number | Z-2381-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 12, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Etac Supply Center Ab |
| Location | Anderstorp, N/A |
| Product Type | Devices |
| Quantity | 13 units |
Product Description
Etac Relax wall mounted shower seat The Etac Relax is a wall mounted shower seat designed as a seating and standing support for personal hygiene purposes for people with reduced mobility. The Etac Relax shower seat is used for sitting where space is restricted, and can be folded up when not in use. Etac Relax is intended for home use.
Reason for Recall
The recalling firm has received reports of a malfunction of the Relax wall mounted shower seat where the wall bracket has cracked or broken.
Distribution Pattern
Nationwide Distribution including FL, AZ, and CA.
Lot / Code Information
The affected products are individually identified within the serial number range: 1-425 regarding Art No. 81703030, 1-205 regarding Art No. 81703050, All distributed regarding Art No. 81703080
Other Recalls from Etac Supply Center Ab
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2073-2015 | Class II | Etac Supporter toilet armrest Etac Supporter t... | Jun 15, 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.