Events

Retiro De Equipo (Recall) de Device Recall Baxter PosiFlow Access Device for IV Access

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 Baxter Healthcare Corp..

¿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
    31275
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0853-05
  • Fecha de inicio del evento
    2005-03-03
  • Fecha de publicación del evento
    2005-06-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-05-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37579
  • 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
    Inadequate directions for use resulting in fluid leaks, valves sticking in the open position, and flow output restriction.
  • Acción
    Urgent Device Correction letters dated 3/3/05 were sent to the direct accounts via first class mail, to the attention of the Director of Nursing. The accounts were informed of the field reports received concerning the PosiFlow Access Device and IV sets containing the PosiFlow device and the changes made to the directions for use and in-service training materials to correct the problems. The accounts were requested to complete and fax back to Baxter at 847-270-5457 the enclosed customer reply form, acknowledging the receipt and dissemination of the information to their staff. Wholesalers were requested to notify their customers. Any questions were directed to the Center for One Baxter at 1-800-422-9837.

Device

Device Recall Baxter PosiFlow Access Device for IV Access
  • Modelo / Serial
    product code 2N9050, all lots
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide
  • Descripción del producto
    Baxter PosiFlow Access Device for IV Access; product code 2N9050; a single use, sterile device with PosiFlow Positive Displacement Feature and Male Luer Lock Adapter, 0.06 mL; Baxter Healthcare Corp., Deerfield, IL 60015 USA; the PosiFlow Access Device is manufactured for Baxter Healthcare Corporation by Becton Dickinson
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • Dirección del fabricante
    Baxter Healthcare Corp., Rt. 120 & Wilson Rd, Round Lake IL 60073
  • Source
    USFDA