Events

Retiro De Equipo (Recall) de BD Vacutainer Push Button Blood Collection Set with 12 in. Tubing

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
    75252
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0745-2017
  • Fecha de inicio del evento
    2016-08-08
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149793
  • 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
    Bd has received multiple reports of units associated with the 23 g x .75 in. bd vacutainer¿ push button blood collection set with 12 in. tubing whose lots are exhibiting separation of front and rear barrels upon activation of the safety feature, which retracts the needle.
  • Acción
    The firm, BD, sent a "URGENT PRODUCT RECALL" letter dated 8/8/2016 to its customer with a return response form via UPS 2nd Day mail on 8/8/2016.The letter described the product, problem and actions to be taken. The customers were instructed to immediately review your inventory for the specific lot numbers, quarantine the product and discontinue the shipment of the affected product; complete and return the Recall Response Form by fax to BD at 1-866-913-0661 or email to bd6835@stericycle.com (even if you do not have any product); return all affected products with completed response form per packing instructions; if you have distributed this product, identify your customers and notify them immediately of this product recall; if you would like BD to conduct the notification to your customers, email your customer list within 3 business days to Matthew.Kelleher@bd.com. if you have any questions or require assistance with the return of the recalled product and/or availability of credit product, contact 1-888-628-0732 between 8Am and 5 PM ET Monday through Friday.

Device

BD Vacutainer Push Button Blood Collection Set with 12 in. Tubing
  • Modelo / Serial
    5355531 5355533 5356681 5356682 6006629 6006630 6006631 6006633 6006634 6006650
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution- US (nationwide) and countries of: Canada, Belgium, Brazil.
  • Descripción del producto
    BD 23 G x .75 in. BD Vacutainer¿ Push Button Blood || Collection Set with 12 in. Tubing || Catalog # 367342 || Intended for venipuncture to obtain blood specimens from patients.
  • 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