Events

Retiro De Equipo (Recall) de Twister(tm) Cube Back-Cane Short, a wheelchair back seat support strap, part number WPHS.

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 Action Products Incorporated.

¿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
    25755
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0812-03
  • Fecha de inicio del evento
    2003-02-25
  • Fecha de publicación del evento
    2003-05-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2003-07-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26436
  • 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
    Wheelchair, Mechanical - Product Code IOR
  • Causa
    Stitching in wheelchair seat back is defective and may not support user.
  • Acción
    Firm notified dealers and sales representatives by certified letter on 2/25/03. Dealers were requested to phone the company for replacement options. Sales representatives were advised of the stitching failure via an 'urgent product recall' letter and instructed to immediately cease use and distribution, and further notify customers. Reps were asked to collect all recalled parts WPHS from consignees they have identified and return with response form.

Device

Twister(tm) Cube Back-Cane Short, a wheelchair back seat support strap, part number WPHS.
  • Modelo / Serial
    LOTS IA702, II327, IK454, IM236
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Product was distributed to dealers, independent sales representatives, and distributors around the US and worldwide.
  • Descripción del producto
    Twister(tm) Cube Back-Cane Short, a wheelchair back seat support strap, part number WPHS.
  • Manufacturer
    Action Products Incorporated

Manufacturer

Action Products Incorporated
  • Dirección del fabricante
    Action Products Incorporated, 22 N Mulberry Street, Hagerstown MD 21740
  • Source
    USFDA