Retiro De Equipo (Recall) de Device Recall Arterial Blood Gas (ABG) Sampling Kit

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.

¿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
  • 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
    Arterial blood sampling kit - Product Code CBT
  • Causa
    Arterial blood gas (abg) kit- missing safety component. the abg kit(s) have been identified as missing the locking clasp component. carefusion/bd has identified a potential customer/user safety risk associated with the missing locking clasp component.
  • Acción
    CareFusion/BD sent out a FIELD SAFETY NOTICE of the field correction in writing on June 27, 2016. The letter described the nature of the recall and provided actions to be performed. Carefusion/BD directed customers to take the following actions: Step #1: Inspect current inventory on-hand to identify the presence of the affected Arterial Blood Gas Sampling Kit(s). Step #2: Complete the Customer Response Form by checking all appropriate boxes and providing all accurate information as required. Step #3: Destroy all affected product(s) in-stock in accordance with their facility's destruction protocol. Step #4: Return the Customer Response Form to Step #5: If the customers want to obtain credit and/or replacement of destroyed product(s) they are asked to call their CareFusion/BD Customer Support Department at 800.323.9088 (Option #1 ). For any additional questions and support concerning the voluntary Field Safety Corrective Action, customers are asked to call (847)362.9303.


  • Modelo / Serial
    Three (3) total lots (lot #884993, lot #903136 & lot #903137).
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - US (nationwide) and Canada.
  • Descripción del producto
    The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sampling for pH, Blood Gas, Electrolyte and Metabolite Analysis.
  • Manufacturer


  • Dirección del fabricante
    Cardinal Health, 1300 Waukegan Rd, Waukegan IL 60085-6724
  • Empresa matriz del fabricante (2017)
  • Source