Events

Retiro De Equipo (Recall) de Device Recall Cook Medical Universa Soft Ureteral Stent and Positioner with Hydrophilic Coating

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 Vance Products Incorporated.

¿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
    50223
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0980-2009
  • Fecha de inicio del evento
    2008-11-10
  • Fecha de publicación del evento
    2009-02-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-11-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75002
  • 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
    Stent, ureteral - Product Code FAD
  • Causa
    "soft" stents were placed in "firm" stent outer boxes. the soft stent is only to be left in the patient for 6 months, but the firm stent can be left in the patient for 12 months, so this error could result in the stent being left in the patient for longer than indicated for the device.
  • Acción
    Consignees were notified via recall letter, "Urgent: Recall Notice" dated November 10, 2008, and by follow-up phone call. Customers were instructed to isolate the recalled product, complete the enclosed form and fax to Cook Urological at 812-829-2353. After receipt of the completed form, Cook Urological will issue a Return Goods Authorization number for each customer to return the affected product to Cook Urological via FedEx or UPS.

Device

Device Recall Cook Medical Universa Soft Ureteral Stent and Positioner with Hydrophilic Coating
  • Modelo / Serial
    Lot Number: U1753668.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution including states of Georgia, Oregon and Texas.
  • Descripción del producto
    Cook Medical Universa Soft Ureteral Stent and Positioner with Hydrophilic Coating, 5.0Fr/26cm, sterile, Cook Urological Inc., Spencer, IN; REF USH-526-R, GPN REF G49966. The product was placed in a shipping box which is preprinted with the word "firm" instead of "soft", but a product specific label stating "soft", as above, was also placed on the box. || The ureteral stent is used for temporary drainage from the ureteropelvic junction to the bladder.
  • Manufacturer
    Vance Products Incorporated

Manufacturer

Vance Products Incorporated
  • Dirección del fabricante
    Vance Products Incorporated, 1100 W Morgan St, Spencer IN 47460-9426
  • Empresa matriz del fabricante (2017)
    Cook Group Incorporated
  • Source
    USFDA