Events

Retiro De Equipo (Recall) de Device Recall BD Vacutainer C&S; Transfer Straw Kit C&S; Preservative Plus Urine Tube

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 & Company.

¿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
    64494
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1056-2013
  • Fecha de inicio del evento
    2013-02-14
  • Fecha de publicación del evento
    2013-04-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-08-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116319
  • 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
    Container, specimen, sterile - Product Code FMH
  • Causa
    The bd vacutainer urinalysis transfer straw kit #364991, lot 1335484 has preprinted polybags which are incorrectly labeled as catalog #364953. bd advises any customer who purchased this kit that the tube in this kit is not a c&s; tube. if a customer relies solely on the polybag labeling and uses the tube inside the kit for the purpose of collecting urine for culture and sensitivity, it is possible.
  • Acción
    BD Diagnostics sent a "Product Advisory Notice" dated February 14, 2013 via UPS Second Day Air to all end user customers. The notice advises customers of the product issue, identifies affected product and provides instructions on how to handle affected product. For questions regarding this recall call 201-847-5033.

Device

Device Recall BD Vacutainer C&S; Transfer Straw Kit C&S; Preservative Plus Urine Tube
  • Modelo / Serial
    Catalog #3694991 appears as Catalog #364953 (Lot #1335484)
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including Arizona, California, Colorado, Georgia, Florida, Illinois, Iowa, Kentucky, Louisiana, Maryland, Massachussets, Michigan, Minnesota, Missouri, New Jersey, New Mexico, New York, North Carolina, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington DC, Washington, West Virginia, and Wisconsin.
  • Descripción del producto
    BD Vacutainer C&S; Transfer Straw Kit C&S; Preservative Plus Urine Tube. 4.0 ml, 13 X 75 mm STERILE REF 364953. Becton Dickinson & Company, Franklin Lakes, NJ USA, || The kit consists of a transfer straw and urinalysis tube intended for UA chemistry urine testing.
  • Manufacturer
    Becton Dickinson & Company

Manufacturer

Becton Dickinson & Company
  • Dirección del fabricante
    Becton Dickinson & Company, 1 Becton Dr, Franklin Lakes NJ 07417-1815
  • Empresa matriz del fabricante (2017)
    Becton, Dickinson and Company
  • Source
    USFDA