Events

Retiro De Equipo (Recall) de Device Recall IFlow ONQ Pain Relief System

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 I-Flow LLC.

¿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
    64826
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1445-2013
  • Fecha de inicio del evento
    2012-06-01
  • Fecha de publicación del evento
    2013-06-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-06-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117138
  • 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
    Catheter, conduction, anesthetic - Product Code BSO
  • Causa
    I-flow initiated two voluntary product removals of the on-q pain relief system: t-block needle/catheter tray and t-block needle/catheter kit because they may have potentially malfunctioned.
  • Acción
    IFlow sent the customer notification letter on May 29, 2013, to 28 customers via FedEx along with a copy of the Service Guide to inform customers of the issue that can cause the Sting Ray to disconnect from the Catheter and how to prevent this problem from occuring. Customers are informed that in certain circumstances, ultrasound gel on the catheters significantly reduces the amount of force required to pull the catheter out of the Stingray connector. The In Service Guide clarifies that the method of catheter securement. It also instructs that wiping off any excess ultrasound gel from the catheter prior to inserting it into the Stingray connector will help with connecting the catheter to the Stingray connector. Customers are instructed that there is no action required for the I Flow ON Q Pain Relief System and ON Q T Bloc. The recall letter is only to provide further instructions on successful set up of the SPIROL catheter with the Stingray Connector included in the ON-Q T-bloc trays. Customers with any questions are instructed to call IFlow Customer service at (800) 448-3569 or IFlow 24 hr Tech support at (800) 444-2728. On June 1, 2012, an I-Flow sales representative removed the catheters and connectors from the one consignee/customers. For questions regarding this recall call 949-206-2700.

Device

Device Recall IFlow ONQ Pain Relief System
  • Modelo / Serial
    Lot # AW207202U
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: USA including states of: CA, CT, FL, IL, IN, KY, NY, OH, OR, TN, TX, VA and WI.
  • Descripción del producto
    I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Kit, Model #TB089T || The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission.
  • Manufacturer
    I-Flow LLC

Manufacturer

I-Flow LLC
  • Dirección del fabricante
    I-Flow LLC, 20202 Windrow Dr, Lake Forest CA 92630-8152
  • Empresa matriz del fabricante (2017)
    Kimberly-Clark Corporation
  • Source
    USFDA