Events

Retiro De Equipo (Recall) de PREMIER CARE RECLINER 5570

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
    67377
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1114-2014
  • Fecha de inicio del evento
    2013-09-06
  • Fecha de publicación del evento
    2014-02-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-12-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125367
  • 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, with casters - Product Code INM
  • Causa
    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.
  • Acción
    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

PREMIER CARE RECLINER 5570
  • Modelo / Serial
    Model 5570. Serial numbers: 557A1100178 thru 557A100206.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    PREMIER CARE RECLINER 5570 with Urethane armrests, Multiple side-table options, 3 position lock-bar, Fully upholstered, OPTIONAL Heat or Heat & Massage, OPTIONAL LiquiCell. || 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
  • Dirección del fabricante
    Winco Mfg., LLC, 5516 SW 1st Ln, Ocala FL 34474-9307
  • Empresa matriz del fabricante (2017)
    Winco Mfg. Llc
  • Source
    USFDA