Events

Retiro De Equipo (Recall) de Xact(tm) Drop Seat Base, a plastic seat support in Xact (tm) Integrated and Xact Individual w/ Drop seat Base Wheelchair cushions.

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
    28201
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0709-04
  • Fecha de inicio del evento
    2004-02-02
  • Fecha de publicación del evento
    2004-07-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2004-09-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31369
  • 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
    Accessories, Wheelchair - Product Code KNO
  • Causa
    Wheelchair seat may not properly support the user due to cracks in the plastic seat base.
  • Acción
    The recalling firm notified dealers by certified letter on 1/19/03. The notification was flagged Attention:Product Recall and advised of seat base susceptibility to cracks and breakage. Dealers were intructed to respond with end user information. Dealers were also provided instructions and materials for crossbar and safety lock installation used with the drop seat bases. Dealers were additionally instructed to forward the provided notification letters to end users.

Device

Xact(tm) Drop Seat Base, a plastic seat support in Xact (tm) Integrated and Xact Individual w/ Dr...
  • Modelo / Serial
    Drop seat bases are not labeled with serial or code numbers, but are found on all wheelchair cushions labeled as Xact Integrated and Xact Individual w/Drop Seat Base.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Product was sold to medical device dealers, primarily pharmacies, nationwide and internationally.
  • Descripción del producto
    Xact(tm) Drop Seat Base, a plastic seat support in Xact (tm) Integrated and Xact Individual w/ Drop seat Base Wheelchair cushions.
  • Manufacturer
    Action Products Incorporated

Manufacturer

Action Products Incorporated
  • Dirección del fabricante
    Action Products Incorporated, 22 N Mulberry St, Hagerstown MD 21740-4910
  • Source
    USFDA