Events

Retiro De Equipo (Recall) de Device Recall ENDURANCE HD

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 Essential Medical Supply, Inc..

¿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
    54810
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2269-2010
  • Fecha de inicio del evento
    2009-12-21
  • Fecha de publicación del evento
    2010-08-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-02-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89229
  • 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
    Mechanical Walker - Product Code ITJ
  • Causa
    Essential medical supply, inc. is recalling w1801b and w1801r endurance hd walkers due to recent reports and tests that show the front caster may detach from the frame. the potential failures include a collapse of the plastic fork or shearing of the stud attaching the caster to the frame.
  • Acción
    All Consignees were mailed an Urgent: Product Recall W1801B and W1801R Endurance HD Walkers notification on December 30, 2009. All notifications were sent first class mail in a 9" X 6" envelope. Response cards were included. The letter identified the affected product and the reason for recall. Customers were asked to examine their inventory for affected product and to discontinue further use or distribution of the product. If the product was further distributed, customers should contact their customers, advise them of the recall and have them return the units to them. Customers should follow the instructions provided for return and replacement of units.

Device

Device Recall ENDURANCE HD
  • Modelo / Serial
    All SS Numbers 05F0002740 to RPN090702497.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    ESSENTIAL MEDICAL SUPPLY, INC. ENDURANCE HD, BUILT TO LAST, HEAVY DUTY FOUR WHEEL WALKER for users up to 500 pounds. || Model W1801B- Blue, UPC 7 54756 91802 6 all serial numbers. || W1801R-Red, UPC 7 54756 91803 3 all serial numbers. || The Endurance HD is a four wheeled steel frame walker with loop locking wheel locks, a padded seat and an under seat tote for carrying personal articles. || Used to assist in ambulation and specifically for obese patients weighing up to 500 pounds. || Warranty Card: "...lifetime of the original purchaser...". Usable life of a walker is 5 years but firm will warranty for lifetime of the original purchaser.
  • Manufacturer
    Essential Medical Supply, Inc.

Manufacturer

Essential Medical Supply, Inc.
  • Dirección del fabricante
    Essential Medical Supply, Inc., 6420 Hazeltine National Dr, Orlando FL 32822
  • Empresa matriz del fabricante (2017)
    Essential Medical Supply Inc
  • Source
    USFDA