Events

Retiro De Equipo (Recall) de Device Recall Access Point Medical Heavy Duty Rollator with Curved Back

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 Access Point Medical 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
    35919
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0155-2007
  • Fecha de inicio del evento
    2006-06-20
  • Fecha de publicación del evento
    2006-11-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-06-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47147
  • 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
    Rolling Walker - Product Code ITJ
  • Causa
    The fork component on the wheel of the rollator can break due to the use of incorrect manufacturing material and/or molding processes.
  • Acción
    The recall was initiated by phone on or about 6/20/06, to determine how many Rollators the customer had in stock because they had received reports of Rollators coming out of the box with cracked forks. During the phone call, the customer was told that the recalling firm was bringing back their remaining inventory for inspection and that customer service would be calling them back to arrange for return. The recalling firm issued a '2nd Recall Notice' dated 10/10/06 via UPS between 10/11-13/06 explaining the reason for recall, requesting their customers to conduct a subrecall down to the consumer level and instructing that all of the Rollators be destroyed.

Device

Device Recall Access Point Medical Heavy Duty Rollator with Curved Back
  • Modelo / Serial
    All Rollators of this model number
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide
  • Descripción del producto
    Access Point Medical-Heavy Duty Rollator with Curved Back (rolling walker), Product Code RL12011, with seat, curved backrest, 8'' wheels with locks, maximum capacity 400 lbs.,and wire basket. Manufactured for Access Point Medical, St. Louis, MO. Made in China
  • Manufacturer
    Access Point Medical LLC

Manufacturer

Access Point Medical LLC
  • Dirección del fabricante
    Access Point Medical LLC, Three City Place Drive, Suite 750, St. Louis MO 63141
  • Source
    USFDA