Events

Retiro De Equipo (Recall) de Device Recall PowerLoc MAX Safety Winged Infusion Set

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.

¿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
    70834
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1560-2015
  • Fecha de inicio del evento
    2015-03-13
  • Fecha de publicación del evento
    2015-04-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-06-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135029
  • 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
    Set, administration, intravascular - Product Code FPA
  • Causa
    Bard access systems is conducting a field action due to the potential that an incorrect maximum flow rate label associated to the power injection ifu for the powerloc max safety infusion set (swis) was attached to the outside of the unit pouch.
  • Acción
    The firm, Bard, sent an "URGENT: Notification-Potential Incorrect Infusion IFU Label for PowerLoc¿ MAX Safety Winged Infusion Set (SWIS)" letter dated March 25, 2015 to its customers. The letter described the product, problem and actions taken. The firm has corrected the cause of the issue and all future lots will be manufactured with the correct maximum flow rate of 2mL/second. Customers may return for a replacement or keep items. Please direct any return requests and questions to our coordinator at 801-522-5640.

Device

Device Recall PowerLoc MAX Safety Winged Infusion Set
  • Modelo / Serial
    Lot D430107
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to states of: GA and MN.
  • Descripción del producto
    PowerLoc MAX Safety Winged Infusion Set, Product Code 0132215 || The PowerLoc MAX Safety Winged Infusion Set is intended for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports. The PowerLoc MAX SWIS is also indicated for power injection of contrast media into the central venous system only with an implanted port that is also indicated for power injection.
  • Manufacturer
    Bard Access Systems

Manufacturer

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