Retiro De Equipo (Recall) de UroSeal Adjustable Endoscopic Valve

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 US Endoscopy Group 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • 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
    Endoscope and/or accessories - Product Code KOG
  • Causa
    Packaging non-conformance related to the integrity of the sterile pouch seal.
  • Acción
    Consignees were notified by phone, e-mail, and an Urgent: US Endoscopy UroSeal Adjustable Valve Recall letter. The letter identified the affected product and the reason for the recall. Customers were asked to remove any affected product from their inventory and quarantine them. Additionally, customers were to complete and return the attached Customer Response Card to Kia Pennington via fax at 1-440-639-4495 or e-mail at as soon as possible. The firm contacted customers regarding the RMA instructions and replacement product. Customers were to follow the RMA instructions in order to receive an RMA number and return the affected product. Questions should be directed towards Kia Pennington in Customer Service at 1-800-769-8229.


  • Modelo / Serial
    Lot 1417696
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Distributed to the states of FL, MO, OH and WI.
  • Descripción del producto
    UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 || The primary packaging is a Tyvek pouch. The secondary package is a corrugate box. 5 units per box. || Used to cover the opening to the biopsy/suction channel of an endoscope.
  • Manufacturer


  • Dirección del fabricante
    US Endoscopy Group Inc, 5976 Heisley Rd, Mentor OH 44060-1873
  • Empresa matriz del fabricante (2017)
  • Source