Events

Recall of Winco Care Cliner Standard Steel Casters

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
    71496
  • Event Risk Class
    Class 2
  • Event Number
    Z-2392-2015
  • Event Initiated Date
    2015-04-02
  • Event Date Posted
    2015-08-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137964
  • 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, adjustable, mechanical - Product Code INN
  • Reason
    Shipment of foam for chairs was received classified as fire retardant but was in fact standard foam and would not meet fire retardant standards.
  • Action
    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.

Device

Winco Care Cliner Standard Steel Casters
  • Model / Serial
    Model Number: 6531, Serial Number: 653A119083
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including CA, FL, KS, KY, LA, MA, MD, MN, MS, NJ, NY, OK, TN, TX, and WA.
  • Product Description
    Winco Care Cliner Standart - Steel Casters || Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
  • 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