Events

Retiro De Equipo (Recall) de Device Recall Infusion Pump Multirate Infusor Devices

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
    65365
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1601-2013
  • Fecha de inicio del evento
    2013-06-07
  • Fecha de publicación del evento
    2013-06-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-06-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119103
  • 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
    Pump, infusion, elastomeric - Product Code MEB
  • Causa
    Baxter healthcare corporation (baxter) is issuing an urgent product recall for the products listed above due to an increase in rupture complaints. baxter has implemented product and process improvements which have substantially improved product quality. complaint rates for ruptures have since decreased. baxter wants to ensure that no affected product remains in the field.
  • Acción
    An Urgent Product Recall notification was sent to all affected consignees on 06/13/2013. The letter states the affected products, problem description, hazard involved and actions to be taken by customer/user, with contact information. The letter was accompanied by a Customer Reply Form and a table of Affected Product List. The recall notification instructs customers to segregate affected product and contact Baxter for instructions for return of product.

Device

Device Recall Infusion Pump Multirate Infusor Devices
  • Modelo / Serial
    Product Codes: 2C1154KP, 2C1155KP, 2C9960KP, 2C9961KP  Lot Numbers: 10F030 10F066 10H043 10H104 10K027 10K099 10M090 10G028 10J059 10M019 10M089 10F058 10G069 10G042 10J048 10M026  Expiration Date: 06/30/13
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed Nationwide and in Puerto Rico.
  • Descripción del producto
    Brand Name: Multirate Infusor Devices. || Indicated for the intravenous administration of medications.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • Dirección del fabricante
    Baxter Healthcare Corp., Route 120 And Wilson Rd, Round Lake IL 60073-9799
  • Empresa matriz del fabricante (2017)
    Baxter International
  • Source
    USFDA