Winco Drop Arm Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, H...

FDA Device Recall #Z-2397-2015 — Class II — April 2, 2015

Recall Summary

Recall Number Z-2397-2015
Classification Class II — Moderate risk
Date Initiated April 2, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Winco Mfg., LLC
Location Ocala, FL
Product Type Devices
Quantity 3 chairs

Product Description

Winco Drop Arm Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.

Reason for Recall

Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.

Distribution Pattern

Nationwide Distribution including CA, FL, KS, KY, LA, MA, MD, MN, MS, NJ, NY, OK, TN, TX, and WA.

Lot / Code Information

Model Number: 6570, Serial Numbers: 657A102238, 658A102236 and 657A102237

Other Recalls from Winco Mfg., LLC

Recall # Classification Product Date
Z-0064-2017 Class II TransMotion Medical, TMM3 Series Video-Fluorosc... Jun 29, 2016
Z-0065-2017 Class II TransMotion Medical, TMM4 Series Multi-Purpose ... Jun 29, 2016
Z-0066-2017 Class II TransMotion Medical, TMM5 Series Mobile Surgica... Jun 29, 2016
Z-2400-2015 Class II Winco Elite Care Cliner w/Swing Away Arms Stand... Apr 2, 2015
Z-2395-2015 Class II Winco Drop Arm Care Cliner Standard - with Nylo... Apr 2, 2015

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.