Class 2 Device Recall Winco XL Convalescent Recliner with Steel Casters

• Date Initiated by Firm: April 02, 2015
• Date Posted: August 14, 2015
• Recall Status: Terminated on December 14, 2016
• Recall Number: Z-2391-2015
• Recall Event ID: 71496
• Product Classification: Chair, adjustable, mechanical - Product Code INN
• Product: Winco XL Convalescent Recliner - with Steel Casters Long term patient recliner (Nursing, Rehabilitation, Geriatric Home Use, Retirement facilities)
• Code Information: Model Number: 5291 Serial Number: 529A004357
• Recalling Firm/ Manufacturer: Winco Mfg., LLC; 5516 SW 1st Ln; Ocala FL 34474-9307
• For Additional Information Contact: Jaime Acevedo; 352-854-2929 Ext. 130
• Manufacturer 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.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Winco sent a field correction letter dated April 2, 2015, to all affected customers The letter identified the product, the problem, and the action to be taken by the customer. Winco instructed customers that they will replace the recliners at no charge to the customer. Winco will provide detailed instructions for the replacement of the seats by their facility staff. Winco will extend the remaining warranty on the entire chair for a period of 6 months as compensation. If product was further distributed customers were instructed to notify those customers of the field correction. Customers were asked to complete and return the enclosed field correction response form as soon as possible. Customers with questions should contact Customer Care Monday-Friday 8:30 AM-5:00 PM EST at 800-237-3377 or email QA-RA@wincomfg.com. For questions regarding this recall call 352-854-2929.
• Quantity in Commerce: 1 chair
• Distribution: Nationwide Distribution including CA, FL, KS, KY, LA, MA, MD, MN, MS, NJ, NY, OK, TN, TX, and WA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.