Events

Retiro De Equipo (Recall) de Device Recall ClariVein IC infusion catheter

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 Vascular Insights, 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
    79324
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1146-2018
  • Fecha de inicio del evento
    2017-11-09
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161969
  • 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, continuous flush - Product Code KRA
  • Causa
    Certain catheters could have a compromised catheter shaft due to a manufacturing defect which could result in some delamination of the catheter shaft including during introduction of the catheter into a vascular access introducer.
  • Acción
    Vascular Insights sent an Urgent Voluntary Medical Device Recall letter to their customers. The letter identified the affected product, problem and the actions to be taken. Customers were instructed to 1. Do not use or distribute any recalled product. 2. Immediately remove all recalled product from your inventory. 3. Segregate recalled product in a secure location and follow the instruction herein to return the recalled product and receive replacement product. 4. Immediately forward a copy of this recall notification to any/all sites to which you may have distributed the affected product and provide directions to follow the instructions contained herein. Customers were asked to complete and return the enclosed Reply Verification Tracking Form.

Device

Device Recall ClariVein IC infusion catheter
  • Modelo / Serial
    Lot number: BM651403017I
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    U.S Nationwide in the states: AZ, CA, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, MO, NE, NJ, NY, OH, PA, SC, TN, TX, VA, WA
  • Descripción del producto
    ClariVein IC infusion catheter, Model Number: 65-018-E4S || Product Usage: || The ClariVein IC infusion catheter is indicated for infusion of physician-specified agents into the peripheral vasculature.
  • Manufacturer
    Vascular Insights, LLC

Manufacturer

Vascular Insights, LLC
  • Dirección del fabricante
    Vascular Insights, LLC, 1 Pine Hill Dr Ste 100, Quincy MA 02169-7485
  • Empresa matriz del fabricante (2017)
    Vascular Insights, LLC
  • Source
    USFDA