Events

Retiro De Equipo (Recall) de Device Recall Medline Excel Shuttle Wheelchair, 24" Wide

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 Medline Industries Inc.

¿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
    47781
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1770-2008
  • Fecha de inicio del evento
    2008-03-31
  • Fecha de publicación del evento
    2008-08-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-05-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70159
  • 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
    Mechanical Wheelchair - Product Code IOR
  • Causa
    Fingers can get injured. there is a potential for users to pinch their fingers between the seat bars when opening the wheelchairs. injuries can be severe from fractures to severing.
  • Acción
    A Voluntary Field Correction letter dated 3/31/08 was issued to customers. The letter informed them of reports of users catching their fingers under the seat bars, which are identified on the chair with warning stickers. The customers were requested to change the backrest with the enclosed replacement upholstery kit, properly dispose of the old back rest, and place the enclosed cautionary tags on both sides of the chair seat. Instructions for installation of the upholstery and cautionary tags were included, as was a sheet entitled "How to Open a Wheelchair" which gives step by step instructions with illustrations for opening the wheelchair, as well as the warning "CAUTION KEEP YOUR FINGERS ON TOP OF THE UPHOLSTERY AT ALL TIMES. DO NOT PLACE YOUR FINGERS ON THE SIDES OR BOTTOM OF THE CHAIR SEAT." The accounts were requested to complete the enclosed response sheet and fax it back to Medline at 847-643-4482, indicating the serial numbers of chairs corrected. Any questions were directed to 800-633-5463, extension 5349, between 8:00 AM and 5:00 PM CST. Distributors were requested to notify their accounts of the recall.

Device

Device Recall Medline Excel Shuttle Wheelchair, 24" Wide
  • Modelo / Serial
    Item numbers MDS809600 and MDS809650; all wheelchairs purchased between 12/01/2005 and 08/31/2007
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Class II Recall - Worldwide Distribution --- including USA and Canada.
  • Descripción del producto
    Bariatric Wheelchair, 24" Wide and 19" Deep Seat, 600 lb. Weight Capacity; Manufactured in Taiwan for Medline Industries, Inc., Mundelein, IL 60060 USA; || Item #MDS809600 comes with Removable Desk-Length Arms, Swing-Away Detachable Footrests, Fixed Height. || item #MDS809650 comes with Removable Desk-Length Arms, Swing-Away Detachable Elevating Legrests, Fixed Height.
  • Manufacturer
    Medline Industries Inc

Manufacturer

Medline Industries Inc
  • Dirección del fabricante
    Medline Industries Inc, 1 Medline Pl, Mundelein IL 60060-4486
  • Source
    USFDA