Winco Mfg., LLC Recalls

FDA
7
Total Recalls
1
Agencies
May 2012
First Recall
Sep 2017
Latest Recall

Showing 1-7 of 7 recalls

FDA

TransMotion Medical, TMM3 Series Video-Fluoroscopy Swallow Study Stretcher-Chair. Intended use is to provide the caregiver a single platform for receiving, transporting within a facility, performing procedures, recovery and discharge of patients in a monitored outpatient environment.

Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications.

Customers were sent an Urgent: Medical Device Recall notification on 7/12/2016 for the specific models of the TransMotion (TMM) Stretcher chairs. The letter explained the reason for the recall and asked customers to take action. Customers are asked to follow the instruction in the Operator Manual for proper egress. Patients are not allowed to egress from the chair without assistance nor should they be left unattended. The chairs will be repaired on site; and, removal of the chair from service is not required with proper supervision and use. Customers are asked to complete the instructions for the acknowledgement form and return. The firm will contact the customers to arrange for repair. Questions regarding the field correction should be directed to the Customer Care department at 800-237-3377 or 352-854-2929 or e-mail QA-RA@wincomfg.com

FDA

Winco XL Convalescent Recliner - with Steel Casters Long term patient recliner (Nursing, Rehabilitation, Geriatric Home Use, Retirement facilities)

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

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.

FDA

PREMIER CARE RECLINER 5570 with Urethane armrests, Multiple side-table options, 3 position lock-bar, Fully upholstered, OPTIONAL Heat or Heat & Massage, OPTIONAL LiquiCell. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation, reclining, eating, patient transport within the facility, and as a patient room chair for visitors.

A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when in a reclined position.

Winco sent a Recliner Field Correction Notification letter dated September 11, 2013 to all affected consignees. The letter identified the product, the problem and action to be taken by the consignees. The consignees were instructed to complete and return the enclosed field correction response form back to Winco so they can send replacement mechanism(s) along with instructions on how to exchange the mechanism(s). Customers with questions were instructed to contact Customer Care at 800-237-3377 or email QA-RA@wincomfg.com. For questions regarding this recall call 352-854-2929, ext 130.

FDA

PREMIER LIFECARE RECLINER 5400 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012 A multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion.

The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 133 fire protection mandate required by California and 4 other states.

Winco sent a Chair Field Correction Notification dated September 24, 2012, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. The consignees were instructed to forward the "Field Correction Form - REPAIR" form back to Winco and the firm would send a Winco Representative to the consignees' facility to correct the chairs in the field. Customers with questions were instructed to contact Winco at 800-237-3377 or email customerservice@wincomfg.com. For questions regarding this recall call 352-854-2929, ext 110.

FDA

Caremor Cliner"***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***Model No. 536 Serial No. 536A-101475***" 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***Padde

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.

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.

FDA

CARE CLINER 6530 (STD)/6540 (X-LG) products are labeled in part: "***CARE CLINER 6530/6540 (w/NYLON CASTERS)***Winco***ISO 9001-2008 Certified***Outstanding Value and Quality in Our Standard Care Cliner***Lower price does not mean lower quality when you buy a Winco Care Clinger. Our standard Care Cliner comes with all the superior features you might find on higher-priced clinical chairs.***KEY FEATURES***Standard head-rest cover***Padded armrests***Dual fold down side-tables***Removable side p

Winco Manufacturing LLC is recalling the Care Cliner, XL Care Cliner, Drop Arm Care Cliner, Elite Care Cliner, and XL Elite Care Cliner chairs with nylon casters distributed between 04/01/2009 and 08/31/2009. Certain 5" nylon casters shipped with the chairs may be defective. There is a potential of the caster's axle working itself out of the assembly under unconventional conditions. Should this

Winco Mfg. sent an "URGENT DEVICE RECALL" letter dated February 1, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers were asked to complete the Caster Recall Replacement Form and return it to the firm's Customer Service Department via fax to 352-854-9544. Contact the Customer Service Department at 800 237-3377 for questions regarding this notice.

FDA

Premier LifeCare Recliner 5400. Brochure is labeled in part: "***Premier LifeCare Recliner 5400***Winco***ISO 9001 2008 Certified***Key Features***Urethane armrests***Fully upholstered***Multiple side-table Options***3-position lockbar*** "No pinch" safety zone***1.800.237.3377***5516 SW 1st Lane***Ocala, Florida 34474***www.wincomfg.com***Proudly Made in the USA.***" Press on type label: "***Manufactured By Winco Ocala, FL 34474***Model No. 540***Serial No. 540-...***" Press on type label:

On 10/17/2011 Winco Mfg. LLC, Ocala, FL initiated a recall of The Premier LifeCare Recliner and Premier Care Recliner Models 5400 and 5570 distributed between January 4, 2011 and October 12, 2011. The Position Lock Pin(s) could potentially fail if exposed to excessive force when the chair is in the Locked Recline position. This failure will result in an inoperable Position Lock Bar feature.

Winco Mfg. sent a "POSITION LOCK PIN RECALL NOTIFICATION" letter dated October 24 , 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to complete and return an enclosed response form and provide product disposition. Winco will ship retro-fit parts to install on the affected product. Instructions will explain step by step, how to implement the fix. Contact Winco at 800-237-3377 for questions regarding this recall.