Events

Retiro De Equipo (Recall) de Device Recall BACTEC PLUS AEROBIC/F AND ANAEROBIC/F MEDIA

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 Becton Dickinson & Co..

¿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
    53961
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1010-2010
  • Fecha de inicio del evento
    2009-11-11
  • Fecha de publicación del evento
    2010-03-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-05-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86955
  • 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
    system, blood culturing - Product Code MDB
  • Causa
    The draw volume on test tubes of blood culture medium is marked with graduations that may be confusing for healthcare practitioners using the tubes for appropriate collection of patient samples for microbiological laboratory testing.
  • Acción
    An "URGENT CUSTOMER NOTIFICATION" was sent via UPS to customers. The notification letter described the product, problem and action to be taken. The letter alerted customers that the firm had recently manufactured identified lots of BACTEC(tm) Blood Culture Media with a new label containing a red line which should not be used as an accurate indication for blood draw volume. The firm also advised that the manufacturer is working to build stock with a revised label, but all of the identified lots distributed had passed testing and release criteria and will continue to perform as expected when used as instructions indicate. The customers are being urged to pay close attention to their BACTEC blood collection procedure until they receive bottles with the revised labels. Drawing too much blood may contribute to false negative or false positive results. The customer is being ask to communicate this information to all specimen collection sites within their facility. If further assistance is needed, please contact BD Technical Services Department at 1-800-638-8663.

Device

Device Recall BACTEC PLUS AEROBIC/F AND ANAEROBIC/F MEDIA
  • Modelo / Serial
    9238806 exp 6/30/2010 9267206 exp 7/31/2010 9267210 exp 7/31/2010 9267213 exp 7/31/2010
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: USA and Canada, Japan, Australia, Singapore, Korea, Brazil, Taiwan, China, Mexico, Germany, New Zealand, Hong Kong, Uruguay
  • Descripción del producto
    BD BACTEC(TM) Standard 10 Aerobic/F Medium, catalog 442260, packed in tubes, 50 tubes/case and labeled in part ***Becton Dickinson and Company, Sparks, MD 21152*** || BD BACTEC Media are used in a qualitative procedure for the culture and recovery of microorganisms from blood.
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.
  • Dirección del fabricante
    Becton Dickinson & Co., 7 Loveton Cir, Sparks MD 21152-9212
  • Empresa matriz del fabricante (2017)
    Becton, Dickinson and Company
  • Source
    USFDA