Chest Support for R82 Mustang, Model Numbers: 861810, 861820, 861830; and Rabbit Up, Model Numbe...
FDA Device Recall #Z-1858-2020 — Class II — March 6, 2020
Recall Summary
| Recall Number | Z-1858-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 6, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | R82 A/S |
| Location | Gedved, N/A |
| Product Type | Devices |
| Quantity | 2230 units |
Product Description
Chest Support for R82 Mustang, Model Numbers: 861810, 861820, 861830; and Rabbit Up, Model Numbers: 869810, 869820, 869830
Reason for Recall
The plastic plug on the chest support for Mustang and Rabbit/Rabbit Up can come loose without use of a tool.
Distribution Pattern
NC
Lot / Code Information
All units distributed from 04/01/2017 to 02/10/2020
Other Recalls from R82 A/S
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0569-2022 | Class II | R82 by ETAC Push Brace for High-Low | Dec 8, 2021 |
| Z-1315-2019 | Class II | Wombat Living, Size 3, Item Numbers: 953121-... | Mar 28, 2019 |
| Z-0441-2019 | Class II | Heron toilet and bath chair Model 880505-01 & 8... | Jun 30, 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.