Events

Retiro De Equipo (Recall) de VYGON LIFECATH S PICC

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 Vygon Corporation.

¿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
    58810
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2700-2011
  • Fecha de inicio del evento
    2011-04-26
  • Fecha de publicación del evento
    2011-06-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100340
  • 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, intravascular, therapeutic, long-term greater than 30 days - Product Code LJS
  • Causa
    Peripherally inserted central catheter has the potential to leak or break at the hub while in use, which could lead to a loss of blood or catheter migration.
  • Acción
    Vygon Corporation sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 26, 2011. The letter identified the affected products, problem, and actions to be taken. The customers were instructed to check inventory and quarantine all affected products; immediately cease use and distribution of all affected products; return any affected products using the instruction from Customer Service involving product pickup (contact Customer Service at 1-800-473-5414 for a Return Merchandise Authorization number); and immediately complete and return the attached form via fax to 215-390-2019. Distributors were provided with instructions on how to handle products that were further distributed. If you have any questions, please contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by e-,ail at customerservice@yygonus.com.

Device

VYGON LIFECATH S PICC
  • Modelo / Serial
    Lot #s: 10I02, S0535, S0624, S0625, S0626, S1025
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution--USA including states of: AZ, CA, FL, MO, NE, NJ, NY, PA, TX, UT, VA, and WA.
  • Descripción del producto
    LIFECATH S PICC with Microflash Introducer || Catheter, Percutaneous, Intravascular || Product Code 2296.214 || Product Usage: Intravascular catheter
  • Manufacturer
    Vygon Corporation

Manufacturer

Vygon Corporation