Events

Recall of XL CONVALESCENT RECLINER

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Winco Mfg., LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    67377
  • Event Risk Class
    Class 2
  • Event Number
    Z-1117-2014
  • Event Initiated Date
    2013-09-06
  • Event Date Posted
    2014-02-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-12-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125378
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Chair, with casters - Product Code INM
  • 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.
  • Action
    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.

Device

XL CONVALESCENT RECLINER
  • Model / Serial
    Model(s) 5291, 529S. Serial numbers: 529A003767, 529A003779, 529A003787, 529A003790, 529A003792 thru 529A003865, 529S100044 thru 529100050.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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.
  • Product 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.
  • Manufacturer
    Winco Mfg., LLC

Manufacturer

Winco Mfg., LLC
  • Manufacturer Address
    Winco Mfg., LLC, 5516 SW 1st Ln, Ocala FL 34474-9307
  • Manufacturer Parent Company (2017)
    Winco Mfg. Llc
  • Source
    USFDA