Events

Retiro De Equipo (Recall) de StatLock IV Premium Catheter Stabilization Device

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 Bard Access Systems 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
    77132
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2120-2017
  • Fecha de inicio del evento
    2017-04-25
  • Fecha de publicación del evento
    2017-05-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-08-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155010
  • 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
    Device, intravascular catheter securement - Product Code KMK
  • Causa
    Statlocktm iv premium catheter stabilization device may contain an incorrectly sized retainer clip.
  • Acción
    Bard Access sent an Urgent: Product Recall letter dated May 15, 2017, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please immediately examine your inventory and quarantine any product subject to this notification. Please complete and return the enclosed response form as soon as possible. Bard Access Systems will provide instructions for returning impacted product for credit or replacement upon receipt of the response form. If you have further distributed this product, please identify your customers and inform them of this notification at once. You may include a copy of this letter in your notification to your customers. Please direct all return requests or other questions to our coordinator for credit or replacement product at 1-800-290-1689. We sincerely regret any inconvenience this may cause to you or your facility. For further questions, please call (801) 522-5000.

Device

StatLock IV Premium Catheter Stabilization Device
  • Modelo / Serial
    Lot Number JUAQF675, Exp 2/28/2019
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution - Internationally to Canada. No govt/VA/Military consignees.
  • Descripción del producto
    StatLock¿ IV Premium Catheter Stabilization Device, product code IV0570. sterile. Packaging: packaged as single units in tyvek to film pouches, the product is distributed in cartons containing 25 devices and cases containing 250 devices.
  • Manufacturer
    Bard Access Systems Inc.

Manufacturer

Bard Access Systems Inc.
  • Dirección del fabricante
    Bard Access Systems Inc., 605 N 5600 W, Salt Lake City UT 84116-3738
  • Empresa matriz del fabricante (2017)
    Becton, Dickinson and Company
  • Source
    USFDA