Events

Retiro De Equipo (Recall) de Device Recall BD Vacutainer(R) Brand Plus PST Separation Tubes

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
    76295
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1189-2017
  • Fecha de inicio del evento
    2017-01-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-02-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152720
  • 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
    Tubes, vials, systems, serum separators, blood collection - Product Code JKA
  • Causa
    A portion of this lot of blood collection tubes was manufactured with approximately twice the expected amount of buffered sodium citrate additive, an anticoagulant.
  • Acción
    BD sent an Urgent Product Recall letter dated January 16, 2017 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the Customer Recall Response Form and fax the completed form back to BD at 1-844-388-5534 or email the completed form to bd8872@stericycle.com. For questions call 1-844-265-7408.

Device

Device Recall BD Vacutainer(R) Brand Plus PST Separation Tubes
  • Modelo / Serial
    Lot 6090572
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide and the countries of Canada, Mexico, Indonesia
  • Descripción del producto
    BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (4.5 ml x 13 x 75 mm) || Catalog Number: 369714 || Product Usage: || The BD Vacutainer Safety Coagulation tube is an evacuated blood collection tube that provides means of collecting, transporting and processing blood in a closed tube. The buffered sodium citrate additive provides an anti-coagulated specimen that may be used for clinical laboratory coagulation assays and determinations
  • 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