Events

Retiro De Equipo (Recall) de Central Lane, 34 weeks

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 Medline Industries 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
    71889
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2458-2015
  • Fecha de inicio del evento
    2015-08-03
  • Fecha de publicación del evento
    2015-08-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-01-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139285
  • 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
    Central venous catheter tray (kit) - Product Code OFF
  • Causa
    The print plate artwork for this lot was found to state: central line <34 weeks kit displaying an incorrect sign in front of the 34. the description for this device should have stated central line >34 weeks kit. the defect may lead to the product to be used on patient population that is <34 weeks rather than intended population of >34 weeks.
  • Acción
    Medline Industries contacted the account directly via phone on August 4, 2015, they confirmed no affected product is in their facility. The lot numbers are easily identified on the outside of each kit. Second and third follow up communications will not be sent as we have confirmed the facility does not have any affected product. For questions regarding this recall call 847-643-4129.

Device

Central Lane, 34 weeks
  • Modelo / Serial
    Central Venous Catheter Kit for patients >34 weeks old with the coding below were affected.   Lot Numbers: 14DB9277 and 14PB2878 Unit No: DYNDC1987A Expiration Date: 06/2015  Serial No: N/A UPC code: N/A
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US including PA
  • Descripción del producto
    Central Line >34 Weeks Kit. Cardiology department. || The Central Line >34 Weeks Kit (DYNDC1987A) is intended for use on patients greater than 34 weeks of age. The central venous catheter, also called a central line, is a long, thin, flexible tube used to give medicines, fluids, nutrients, or blood products over a long period of time, usually several weeks or more. A catheter is often inserted in the arm or chest through the skin into a large vein. The catheter is threaded through this vein until it reaches a large vein near the heart.
  • Manufacturer
    Medline Industries Inc

Manufacturer

Medline Industries Inc
  • Dirección del fabricante
    Medline Industries Inc, 1 Medline Pl, Mundelein IL 60060-4485
  • Empresa matriz del fabricante (2017)
    Medline Industries Inc.
  • Source
    USFDA