Retiro De Equipo (Recall) de Device Recall BD Vacutainer PLUS K2EDTA Blood Collection 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
    72868
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0569-2016
  • Fecha de inicio del evento
    2015-12-03
  • Fecha de publicación del evento
    2015-12-31
  • Estado del evento
    Open, Classified
  • País del evento
  • Fuente del evento
    USFDA
  • 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
    Tubes, vials, systems, serum separators, blood collection - Product Code JKA
  • Causa
    Some of the blood collection tubes in these lots were manufactured with insufficient edta additive. an insufficient edta additive may lead to erroneous platelet results, specimen recollection, or a delay of treatment.
  • Acción
    The firm, BD, issued an "URGENT PRODUCT RECALL" notifications/Recall Response Forms to their customers dated 12/3/2015 via email and/or UPS 2nd Day Mail. The notification identified the reason for the recall; how to identify affected product; and actions to be taken. The customers were instructed customers to immediately review their inventory; complete the enclosed Recall Response Form and fax (1-866-873-0312 it to BD or email it to bd4964@stericycle.com; and return all affected products with the completed Recall Response Form following instructions on the enclosed packing instruction, even if you do not have any affected lot in your inventory. If customers have any questions or require assistance with the return of the recalled product and/or availability of replacement product, they were instructed to contact 1-888-628-0732 between 8AM and 5 PM ET Monday through Friday.

Device

  • Modelo / Serial
    Catalog Reference #368054; Lot numbers 5089827, 5210514, 5154646, 5210511.  Catalog Reference #367856; Lot number 5064666
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (Nationwide) and the countries of: European Union, Peoples Republic of China, Japan and Republic of Korea.
  • Descripción del producto
    BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x || 3.0 mL (Lavender) BD Hemogard Additive: K2EDTA (spray dried), 5.4mg Sterile IVD BD, Made in USA || BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing serum, plasma or whole blood in the clinical laboratory. The BD Vacutainer¿ Plus K2EDTA Tubes may be used for routine immunohematology testing and blood donor screening.
  • Manufacturer

Manufacturer

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