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U.S. Department of Health and Human Services

Class 2 Device Recall Winco Drop Arm Care Cliner Standard with Nylon Casters

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  Class 2 Device Recall Winco Drop Arm Care Cliner Standard with Nylon Casters see related information
Date Initiated by Firm April 02, 2015
Date Posted August 14, 2015
Recall Status1 Terminated 3 on December 14, 2016
Recall Number Z-2395-2015
Recall Event ID 71496
Product Classification Chair, adjustable, mechanical - Product Code INN
Product Winco Drop Arm Care Cliner Standard - with Nylon Casters
Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
Code Information Model Number: 6550, Serial Numbers: 655A108119, 655A108120, 655A108121, 655A108122, 655A108123,   655A108124, 655A108125, 655A108126, 655A108127, 655A108128, 655A108129,  655A108130, 655A108131, 655A108132, 655A108133, 655A108134, 655A108135,  655A108136, 655A108137, 655A108138, 655A108139, 655A108140, 655A108141, 655A108142, 655A108143, 655A108144, 655A108145, 655A108146, 655A108147, and 655A108148 
Recalling Firm/
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 2
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 30 chairs
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.