Retiro De Equipo (Recall) de Device Recall BD BBL (tm) LowensteinJensen Medium Deeps

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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización 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
    System, blood culturing - Product Code MDB
  • Causa
    Media fails to perform as intended with quality control organism mycobacterium kansasii.
  • Acción
    The firm, BD Diagnostic Systems, sent an "URGENT PRODUCT RECALL" letter dated January 2012 to Ex-US BD sites via email and its customers via UPS ground shipment on 1/30/12. The letter identified the product, the problem and the action to be taken. The customers were instructed to discontinue use of the recalled lot numbers and discard any remaining packages. Customers were also instructed to complete and return the attached form whether or not they had any inventory remaining via fax to: BD Regulatory Compliance at 410-316-4285. The letter also informed the customers that BD has decided to discontinue this product. If further assistance is needed regarding credit, please contact BD Customer Service Department at 1-800-675-0908. For all other inquiries, please contact BD Technical Services Department at 1-800-638-8663.


  • Modelo / Serial
    Catalog #221257, Lot 0091498 Exp. 10/6/11, Lot 0224698 Exp. 2/16/12, Lot 0301803 Exp. 5/3/1112, Lot 1055386 Exp. 8/30/12, Lot 1167837 Exp. 12/20/12
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - USA (nationwide) including states of: AL, CA, CT, IA, IL, KY, LA, MD, MI, MN, NC, NJ, NY, OH, PA, TN, VA, WA, and WV; and countries of : Belgium and Singapore.
  • Descripción del producto
    BD BBL (tm) Lowenstein-Jensen Medium Deeps, Catalog #221256, packaged in boxes of ten/600 mL tubes. Product Usage: Lowenstein-Jensen Medium is used for the isolation and cultivation of mycobacteria. The medium tubed as deeps is used for the semi-quantitative catalase test as an aid to the classification of mycobacteria.
  • Manufacturer


  • Dirección del fabricante
    Becton Dickinson & Co., BD Diagnostic Systems, 7 Loveton Circle, Sparks MD 21152-0999
  • Empresa matriz del fabricante (2017)
  • Source