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U.S. Department of Health and Human Services

Class 2 Device Recall Caremor Cliner

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  Class 2 Device Recall Caremor Cliner see related information
Date Initiated by Firm July 10, 2012
Date Posted October 10, 2012
Recall Status1 Terminated 3 on May 23, 2013
Recall Number Z-0032-2013
Recall Event ID 63085
Product Classification Chair, with casters - Product Code INM
Product Caremor Cliner is labeled in part: "***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***Model No. 535 Serial No. 535A-104522***"

Literature: "***Caremor Cliner 5351/5361***Winco***ISO 9001-2008 Certified***Our most comfortable and versatile recliner***Ease of operation, outstanding durability, and exceptional value have made this one of our bestselling recliners. The Caremor Cliner provides patient comfort and support as well as user friendly features.***KEY FEATURE'S***Infinite positioning back***Padded armrests w/arm guard***Webbed elastic suspension back and seat***Removable side panels**Continuous seat & legrest cushion***5351 w/tray***5361 w/out tray***1.800.237.3377***5516 SW 1st Lane***Ocala, Florida 34474***www.wincomfg.com***Proudly Made in the USA***"
Patient recliner chair
Code Information Model Number 5351
Recalling Firm/
Manufacturer		 Winco Mfg., LLC
5516 SW 1st Ln
Ocala FL 34474-9307
For Additional Information Contact
352-854-2929
Manufacturer Reason
for Recall		 Winco Mfg., LLC in Ocala, FL is recalling the Caremor Cliner model numbers 5351 and 5361. The recall was initiated due to a report that a back frame did not "snap" onto a chair frame properly.
FDA Determined
Cause 2		 Process control
Action Winco notified consignees via phone except for the one located in Saudi Arabia, who was contacted by e-mail. All consignees have been sent a follow-up e-mail. The notification identified the product, the problem, and the action to be taken to be taken by the customer. Customers should remove the chair from use and the upholstered back will not be required to be returned. Winco will send out new fully assembled upholstered backs. For questions customers should call 352-854-2929, ext 123.
Quantity in Commerce 20 chairs
Distribution Worldwide Distribution - USA including Arkansas, California, Maryland, Mississippi, New York, Pennsylvania and the country of Saudi Arabia
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.
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