Events

Retiro De Equipo (Recall) de Device Recall Sit/stand Rolling Walker

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 Central Purchasing LLC DBA Harbor Freight Tools.

¿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
    67876
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1451-2014
  • Fecha de inicio del evento
    2014-03-27
  • Fecha de publicación del evento
    2014-04-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-08-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126545
  • 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
    Walker, mechanical - Product Code ITJ
  • Causa
    Harbor freight tools intiaited a recall of sit/stand rolling walker (sku/item number 66838, sold june 2009 to march 2014) because, over time, there is the possibility that a walker wheel may come off this product following repeated use without tightening the wheel bolt to the frame, presenting a potential hazard for the user.
  • Acción
    Recall communication to web site customers who purchased the product, notifying them of recall and availability of full refund for product. Store posting notifying retail customers of the recall and availability of full refund for product (with a similar posting provided on the HFT web site). Consumers are informed of the recall, product info. with photo, item number, reason for recall, hazard, instructed to stop using these walkers immediately, and contact information provided telephone number, and e-mail address. Consumer letters also provided with a Merchandise Return Label. On 04/02/14, an updated consumer letter issued.

Device

Device Recall Sit/stand Rolling Walker
  • Modelo / Serial
    SKU/Item Number 66838, Sold June 2009 to March 2014.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    Sit/stand Rolling Walker, SKU/Item Number 66838. Intended for use by those with difficulty walking and weighing 225 lbs. or less.
  • Manufacturer
    Central Purchasing LLC DBA Harbor Freight Tools

Manufacturer

Central Purchasing LLC DBA Harbor Freight Tools
  • Dirección del fabricante
    Central Purchasing LLC DBA Harbor Freight Tools, 26541 Agoura Rd, Calabasas CA 91302-2093
  • Empresa matriz del fabricante (2017)
    Central Purchasing Llc
  • Source
    USFDA