Events

Retiro De Equipo (Recall) de Device Recall Caremor Cliner

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
    63085
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0032-2013
  • Fecha de inicio del evento
    2012-07-10
  • Fecha de publicación del evento
    2012-10-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-05-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112496
  • 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
    Winco mfg., llc in ocala, fl is recalling the caremor cliner model numbers 5351 and 5361. the recall was initiated due to a report that a back frame did not "snap" onto a chair frame properly.
  • Acción
    Winco notified consignees via phone except for the one located in Saudi Arabia, who was contacted by e-mail. All consignees have been sent a follow-up e-mail. The notification identified the product, the problem, and the action to be taken to be taken by the customer. Customers should remove the chair from use and the upholstered back will not be required to be returned. Winco will send out new fully assembled upholstered backs. For questions customers should call 352-854-2929, ext 123.

Device

Device Recall Caremor Cliner
  • Modelo / Serial
    Model Number 5351
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including Arkansas, California, Maryland, Mississippi, New York, Pennsylvania and the country of Saudi Arabia
  • Descripción del producto
    Caremor Cliner is labeled in part: "***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***Model No. 535 Serial No. 535A-104522***" || Literature: "***Caremor Cliner 5351/5361***Winco***ISO 9001-2008 Certified***Our most comfortable and versatile recliner***Ease of operation, outstanding durability, and exceptional value have made this one of our bestselling recliners. The Caremor Cliner provides patient comfort and support as well as user friendly features.***KEY FEATURE'S***Infinite positioning back***Padded armrests w/arm guard***Webbed elastic suspension back and seat***Removable side panels**Continuous seat & legrest cushion***5351 w/tray***5361 w/out tray***1.800.237.3377***5516 SW 1st Lane***Ocala, Florida 34474***www.wincomfg.com***Proudly Made in the USA***" || Patient recliner chair
  • 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