Events

Retiro De Equipo (Recall) de Device Recall VariSafe

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
    Recall
  • ID del evento
    74590
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0289-2017
  • Fecha de inicio del evento
    2016-05-18
  • Fecha de publicación del evento
    2016-10-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-05-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147998
  • 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
    endoscopic injection needle, gastroenterology-urology - Product Code FBK
  • Causa
    Us endoscopy is conducting a voluntary product recall of one lot of the vari-safe injection needle as it was identified that the lot was incorrectly distributed. the lot was assembled with internal catheter components which differ from the original vari-safe needle internal catheter components. all components are dimensionally similar to the original vari-safe needle internal catheter components and the components have history of use on other us endoscopy needle products.
  • Acción
    US Endoscopy sent an Urgent- (Vari Safe) injection needle recall letter dated July 6, 2016. US Endoscopy requests that you: 1.Quarantine the affected Vari-Safe Injection devices in your stock. 2. Destroy each affected device by opening the device package, cutting the device catheter with a scissors, and then discarding the device and package. 3.Complete the attached Customer Response Card and return to the attention of US Endoscopy Customer Service, via fax 1-440-639-4495 or email orders@us endos copy.com . A no charge replacement will be provided for each unused Vari-Safe Injection Needle device from the affected lot. We apologize for any inconvenience this matter may cause you, and as always, US Endoscopy is dedicated to supporting our products and valued Customers. For further questions please call (800) 769-8226.

Device

Device Recall VariSafe
  • Modelo / Serial
    Model #: 00711819; Lot 1520268
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to the states of : OH, OR, WA and Internationally to the country of Italy.
  • Descripción del producto
    Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060 || A sterile, single use, flexible sheath device intended to be used for the injection of various types of media through flexible endoscopes
  • Manufacturer
    US Endoscopy Group Inc

Manufacturer

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