Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0032-2013Class II

Caremor Cliner is labeled in part: "***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***Model No...

Champion Mfg, Inc. / initiated 2012-07-10 / Terminated / root cause: manufacturing process

Winco Mfg., LLC began a recall of Caremor Cliner is labeled in part: "***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***Model No. 535 Serial No. 535A-104522***" Literature... on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0032-2013
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Champion Mfg, Inc.
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
Product code
INM Chair, With Casters
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.
Root cause tag
manufacturing process
FDA root cause
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
Product codes and lots
Model Number 5351

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0032-2013
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0031-2013Class IITerminatedVoluntary: Firm initiated
Z-0032-2013Class IITerminatedVoluntary: Firm initiated