Retiro De Equipo (Recall) de Device Recall Access Point Quad Canes

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
    35920
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0204-2007
  • Fecha de inicio del evento
    2006-03-10
  • Fecha de publicación del evento
    2006-11-22
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2008-04-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    cane - Product Code IPS
  • Causa
    The canes were made of unacceptable materials and could break.
  • Acción
    The firm began making telephone calls and issuing recall letters dated 3/9/06 via UPS on 3/10/06. The telephone call explained the reason for recall and notified the customer they would be receiving a letter requesting return of the canes. The letter additionally notified the customer the recall was to be affected to the retail level. A customer response form was enclosed. The firm issued a second recall letter dated 12/22/06 via registered mail on 12/26/06 explaining the reason for recall, pointing out the hazard involved with the use of the recalled canes, and requesting they cease sales of the product. The letter requested they notify their customers of the recall and to post the enclosed recall placard where it can be seen by returning customers. Recall instructions were enclosed outlining step-by-step instructions for their customer to follow, including destroying the canes on site. A Customer Response Form was also enclosed. The firm issued a third letter dated 1/11/07 via regular mail which included a corrected placard because the product code numbers were incorrect in the placard included with the letter dated 12/22/06. The customers were instructed to discard the previous placard.

Device

  • Modelo / Serial
    All canes bearing the model number.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide.
  • Descripción del producto
    Access Point Medical Canes, Quad Cane, Small Base - Gold, Product Code CN11050B, and Small Base - Chrome, Product Code CN11050C, both packaged 6/case. The responsible firm is Access Point Medical, St. Louis, MO.
  • Manufacturer

Manufacturer

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