Events

Retiro De Equipo (Recall) de Winco Care Cliner XLarge with Steel Casters

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Winco Mfg., LLC.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    71496
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2394-2015
  • Fecha de inicio del evento
    2015-04-02
  • Fecha de publicación del evento
    2015-08-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-12-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137970
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Chair, adjustable, mechanical - Product Code INN
  • Causa
    Shipment of foam for chairs was received classified as fire retardant but was in fact standard foam and would not meet fire retardant standards.
  • Acción
    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 XLarge with Steel Casters
  • Modelo / Serial
    Model Number: 6541, Serial Numbers: 654A105210, 654A105204, 654A105208 and 654A105209.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including CA, FL, KS, KY, LA, MA, MD, MN, MS, NJ, NY, OK, TN, TX, and WA.
  • Descripción del producto
    Winco Care Cliner X-Large - with Steel Casters || Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
  • Manufacturer
    Winco Mfg., LLC

Manufacturer

Winco Mfg., LLC
  • Dirección del fabricante
    Winco Mfg., LLC, 5516 SW 1st Ln, Ocala FL 34474-9307
  • Empresa matriz del fabricante (2017)
    Winco Mfg. Llc
  • Source
    USFDA