FDA Enforcement Class II Terminated

XL CONVALESCENT RECLINER 5291/529S with Padded armrests with guard, Dual fold down side-tables, Removable side panels, Built-in head-rest. 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.

Recall: Z-1117-2014 · Reported March 5, 2014

Enforcement

Recall Number
Z-1117-2014
Event ID
67377
Classification
Class II
Status
Terminated
Product Type
Devices
Firm
Winco Mfg., LLC
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
March 5, 2014
Initiation Date
September 6, 2013
Classification Date
February 26, 2014
Termination Date
December 30, 2014
Address
5516 SW 1st Ln, Ocala, FL, 34474-9307, United States

Description

XL CONVALESCENT RECLINER 5291/529S with Padded armrests with guard, Dual fold down side-tables, Removable side panels, Built-in head-rest. 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.

Reason

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.

Code Info

Model(s) 5291, 529S. Serial numbers: 529A003767, 529A003779, 529A003787, 529A003790, 529A003792 thru 529A003865, 529S100044 thru 529100050.

Distribution

Worldwide Distribution - USA nationwide including Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kanas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia, Puerto Rico and Internationally to the country of Canada.

Quantity

369 units (all models)