Events

Retiro De Equipo (Recall) de Device Recall 13.5 mm x 50 mm BrainPath Sheath

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 Nico Corp..

¿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
    62588
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2200-2012
  • Fecha de inicio del evento
    2012-07-17
  • Fecha de publicación del evento
    2012-08-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-11-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111098
  • 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
    Retractor, self-retaining, for neurosurgery - Product Code GZT
  • Causa
    Brainpath sheaths were mislabeled. sheaths which measure 50mm were labeled as 60mm. the length callout on the label does not match the actual length of the sheath within the packaging resulting in an improper fit as further explained below. this mislabeling was discovered on 29-june-2012 during a clinical case.
  • Acción
    NICO Neuro and Spine sent an Urgent Recall letter to all affected customers on July 18, 2012. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to complete the recall response form. Affected sheaths distributed within the US will be obtained and discarded by NICO. Affected sheaths shipped to Canada will be obtained and discarded by NICOs distributor, Galen Medical. For questions customers should call 888-632-7071.

Device

Device Recall 13.5 mm x 50 mm BrainPath Sheath
  • Modelo / Serial
    REF: NN-8011 - LOT: 80344-TD00214 (manufactured on 11-April-2012)
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including MI and Canada
  • Descripción del producto
    13.5 mm x 50 mm BrainPath Sheath || The NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sheaths (three lengths available for each: 50mm, 60mm, and 75mm). The obturator and sheath are assembled in the OR immediately prior to use. These two components are held together by an interference fit. The device when used as intended is designed to provide access to neurological tissues.
  • Manufacturer
    Nico Corp.

Manufacturer

Nico Corp.
  • Dirección del fabricante
    Nico Corp., 12263 Bridgewater Rd, Indianapolis IN 46256-9428
  • Empresa matriz del fabricante (2017)
    NICO Corp
  • Source
    USFDA