Retiro De Equipo (Recall) de Device Recall Plum 360" Infusion System with Hospira Mednet", Smart Card Plug 'N Play, Upgrade 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 ICU Medical 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Estado del evento
    Open, Classified
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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 - Product Code FRN
  • Causa
    Potential for the connectivity engine module of the affected unit to disengage from the main chassis, causing the unit to shut down without an alarm notification. this would delay initiation of therapy or interrupt an infusion.
  • Acción
    ICU Medical sent an Urgent - Medical Device Correction letter dated June 15, 2017, to all affected customers. The firm contracted with Stericycle for recall notification, response tracking, and effectiveness checks. The customer notification was also posted on The notification requested that consignees verify their unit is working and testing the CE Module. If the unit's CE Module is loose or a blank display occurs, customers are asked to record the S/N and contact ICU Medical Technical Service Support Center at 800-241-4002, option 4. If the unit is functional, return to service. If the unit powers down without an alarm notification, use another unit and contact ICU Medical Global Complaint Management at 800-441-4100. The firm will contact reporting consignees of correction scheduling when parts become available. Adverse reactions or quality problems related to this problem should be reported to FDA's MedWatch Adverse Event Reporting Program by mail, fax, or online. Consignees are advised to inform potential users within their organization of the recall and to complete the recall response form attached to recall notification. The completed response form can be returned by email to or faxed to 855-544-4814. If product was distributed, ask customers to request them to contact Stericycle for a copy of recall notification at 855-544-4813.


  • Modelo / Serial
    Model No. 30010
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - USA (nationwide) Distribution to the states of including Puerto Rico : AL, AR, AZ, CA, FL, GA, HI, IA, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NE, NH, NJ, NM, NY, OH, PA, SD, TN, TX, VA, WA, WI, WY and District of Columbia., and to the countries of : Australia, Canada, Chile, Colombia, France, Greece, Hong Kong, Ireland, Italy, Jordan, Kuwait, Mexico, New Zealand, Oman, Peru, Philippines, Poland, Saudi Arabia, Spain, Turkey, United Arab Emirates, and United Kingdom.
  • Descripción del producto
    Plum 360 Infusion System
  • Manufacturer


  • Dirección del fabricante
    ICU Medical Inc, 600 N Field Dr, Lake Forest IL 60045-4835
  • Empresa matriz del fabricante (2017)
  • Source