Retiro De Equipo (Recall) de Stiffened Micro Introducer KIts

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 Angiodynamics, Inc..

¿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 3
  • Número 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
    Introducer, catheter - Product Code DYB
  • Causa
    Greatbatch medical the manufacturer of the 4f and 5f sheath/dilator components has determined that the products listed in their september 7, 2016 recall notification have the potential for the rotating luer to detach from the dilator hub during use. angiodynamics has confirmed that affected sheath/dilators (greatbatch model numbers 10904-001 and 10904-002) have been included in packaged angiodynamics stiffened micro-introducer kits.
  • Acción
    Angiiodynamics sent an Urgent Voluntary Medical Device Recall letter dated September 28, 2016, to all affected customers. Recall notifications were delivered by Federal Express. Customers were instructed to segregate and return all affected devices to AngioDynamics and to complete and return the Reply Verification Tracking Form, provided in the recall notification by fax to 1-800-782-1357. Customers were encouraged to forward a copy of the recall notification to all sites to which have distributed affected product. If affected product is located in your institution, please call AngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday  Friday: Eastern Standard Time) to obtain a replacement or credit for your returned product. Promptly complete, sign and return the enclosed Reply Verification Tracking Form (even if you do not have any product to return); following the directions on this page and the Reply Verification Tracking Form via to Customers with questions should contact customer service at 1-800-772-6446.


  • Modelo / Serial
    Batch/Lot: 1) 5046426, 2) 5022317, 5032458, 5040672, 5046428, 5063983 & 5081983
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide Distribution to AL, AR, CA, FL, GA, IL, KY, LA, MI, MN, MO, NC, OH, OK, SC, NY, ME, PA, MD, VA, WA, WI, WV, TN, and TX
  • Descripción del producto
    ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM SS/SS ECHO B PG, Item Number H787065970395, Catalog No.REF 06597039, 2) 5 F Stiffened Micro-Introducer Kit, STF 5F M.I. KIT 45CM SS/SS ECHO S PG, Item Number H787065970415, Catalog No. REF 06597041 || Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick
  • Manufacturer


  • Dirección del fabricante
    Angiodynamics, Inc., 603 Queensbury Ave, Queensbury NY 12804-7619
  • Empresa matriz del fabricante (2017)
  • Source