Events

Retiro De Equipo (Recall) de Alaris Pump Module (formerly Medley Pump Module)

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 Cardinal Health 303 Inc DBA Alaris Products.

¿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
    45504
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0460-2008
  • Fecha de inicio del evento
    2007-10-29
  • Fecha de publicación del evento
    2008-01-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-06-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65661
  • 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
    Infusion Pump - Product Code FRN
  • Causa
    Inaccurate flow rate; related to misassembled (missing, bent or broken) springs during the manufacturing or servicing of the mechanism assembly.
  • Acción
    The field notification (Urgent Medical Device Recall Letter) will consist of a mailing conducted through consignees (distributors in the affected countries as well as direct customers for the Alaris Pump module (a.k.a. Medley Pump module). The domestic letters are expected to be mailed on November 5, 2007 to all of the affected accounts by return receipt mailing. A Customer Response Card will be mailed with each letter along with a Service Bulletin detailing the protocol to conduct the Occluder Pressure Test. Four (4) letters will be mailed to each account to the following titles/job functions: Director of Nursing, Director of Biomed, Director of Materials Management, and Director of Risk Management. Distributors will be sent multiple copies of the Recall Notification, Customer Response Cards, and Service Bulletin, along with a cover letter outlining their responsibilities to complete the Recall notification plan and notify their customers as requested. The letters will be the first source of communication regarding this issue. The Recall Center will be contacting customers shortly to make arrangements for inspection of the devices at the users site. The international mailings are being coordinated out of the offices located in the affected countries. The letter will be translated to the appropriate language and mailed to all of the affected customers. The appropriate international regulatory authorities will be notified of this issue, and will work with the country managers.---------A web site for all information on this recall is listed as: www.cardinalhealth.com/alaris/indexmodulealert.asp ****************** January 23, 2008 the firm notified the Los Angeles Districe that they will be sending a recall notification update to 267 customers and distributors who are affected by this 806 Notification Amendment. Cardinal Health intends to notify these consignees by mail on January 30, 2008. This update will affect a total of 267 customers, 5,681 units and 798

Device

Alaris Pump Module (formerly Medley Pump Module)
  • Modelo / Serial
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide: USA including the following forty-six (46) states, along with Washington, D.C. Puerto Rico and Guam: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, and Wyoming and countries of Canada & Saudi Arabia (Note: Devices were shipped to the Cardinal Health Distribution Center in the Netherlands. These devices were then shipped to Saudi Arabia.)
  • Descripción del producto
    Cardinal Health Alaris Pump Module (formerly Medley Pump Module), Model 8100, Cardinal Health, San Diego, CA. (All Alaris Pump modules shipped prior to December 23, 2007 are subject to this recall)
  • Manufacturer
    Cardinal Health 303 Inc DBA Alaris Products

Manufacturer

Cardinal Health 303 Inc DBA Alaris Products
  • Dirección del fabricante
    Cardinal Health 303 Inc DBA Alaris Products, 10221 Wateridge Cir, San Diego CA 92121-2733
  • Source
    USFDA