Events

Recall of Device Recall Care Cliner

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
    61457
  • Event Risk Class
    Class 2
  • Event Number
    Z-1461-2012
  • Event Initiated Date
    2012-02-06
  • Event Date Posted
    2012-04-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108147
  • 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
    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.
  • Action
    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.

Device

Device Recall Care Cliner
  • Model / Serial
    Model 6980, 6988
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Canada and Singapore.
  • Product Description
    NOCTURNAL ELITE CARE CLINER 6980(STD)/6990(X-LG) products are labeled in part: "***NOCTURNAL ELITE CARE CLINER 6980/6990***Winco***ISO 9001-2008 Certified***An infinite position recliner, independent leg rest and lay-flat all in one chair!***With lay-flat positioning and an independent leg rest, Winco's Nocturnal Elite Care Cliner provides optimal comfort for use in nocturnal dialysis, oncology, acute care and other patient care areas.***HEAT MASSAGE (Optional)***KEY FEATURES***Left side swing-arm for modified entry and ease of cleaning***User-adjustable positioning***Attendant controlled Trendelenburg foot release (on left & right side)***Left side fold down table***Right side Pivot Table***Rear push handle**Lay Flat***Hide-away foot rest***Independent leg rest***LiquiCell for added comfort***1.800.237.3377***5516 SW 1st Lane***Ocala, Florida 334474***www.wincomfg.com***". || The Care Cliner is a multi position recliner with a steel frame used primarily in clinics, hospitals and treatment centers for recovery, dialysis, oncology, examination, infusion. || Sticker with serial number is labeled in part: "***Manufactured By***Winco***Ocala, FL 34474***www.wincomfg.com*** Model No. ***Serial No.***" || Note: Model 6988 is a version of the 6980 without the footplate. We have a single, but high volume customer, that requested the chair without the footplate. We put the model in the system so as to call out a specific Bill of Materials to leave off the footplate. Since it was a unique request, there is not a piece of literature for it.
  • 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