Events

Retiro De Equipo (Recall) de Device Recall Stryker Renaissance Series Stretchers

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 Stryker Medical Div. of Stryker Corporation.

¿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
    55139
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2186-2010
  • Fecha de inicio del evento
    2010-03-19
  • Fecha de publicación del evento
    2010-08-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-05-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90005
  • 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
    Powered Wheeled Stretcher - Product Code INK
  • Causa
    The retractable cord stretchers were fitted with power cords, manufactured by electri-cord, whose prongs have the potential to fracture inside the molded section of the plug, causing melting and charring.
  • Acción
    The firm has sent Urgent - Medical Device Recall letters, dated March 19, 2010, to all direct accounts notifying them of the recall. The letter identified the affected product and described the reason for recall. Customers were asked to locate the stretchers identified in the letter and visually inspect each cord. If the plug shows signs of excessive wear, etc. the stretcher is to be taken out of service immediately and the plug removed. Customers are to call the number provided in order to be placed on the priority replacement list. If the cord does not show signs of damage then the stretcher can remain in service until a replacement cord is available. The enclosed post card should be completed and returned to the firm. A copy of the notice should be forwarded to any users that stretchers have been sold or loaned to. The firm should be provided with the serial numbers of any stretchers that have been disposed of. Questions should be directed towards Stryker at 800-STRYKER.

Device

Device Recall Stryker Renaissance Series Stretchers
  • Modelo / Serial
    Model 1731: 19 Units 0306055261, 0306055262, 0311054605, 0311054606, 0311058060, 0311058130, 0311058491, 0311058492, 0312050810, 0406059715, 0406059835, 0406059836, 0406059837, 0407059289, 0407059290, 0407059291, 0409062599, 0409064150, and 0409064258.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, Canada, Brazil, Japan, Singapore, Spain, and the Far East.
  • Descripción del producto
    Stryker Renaissance Series Stretchers, Model 1731Z PACU with Zoom, Stryker Medical, Portage, MI.
  • Manufacturer
    Stryker Medical Div. of Stryker Corporation

Manufacturer

Stryker Medical Div. of Stryker Corporation
  • Dirección del fabricante
    Stryker Medical Div. of Stryker Corporation, 3800 E. Centre Ave., Portage MI 49002
  • Source
    USFDA