Retiro De Equipo (Recall) de John Bunn 1392 Series Jackson Tracheostomy Stainless Steel 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 Gf Health Products, 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 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación 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
    tracheostomy tube - Product Code BTO
  • Causa
    Incorrect material. manufacturer changed the material of the trach tube from stainless steel to german silver/nickel, contrary to product specifications.
  • Acción
    GF Health Products (Graham Field) notified consignees by certified US Mail on/about 09/14/2009. The distribution to the dealers includes the announcement of the recall to the dealer the letter to send to the end users and a Proof of Compliance card for the dealer to submit to Graham Field following completion of the recall instructions. Graham-Field instructed the dealers to return any impacted products on site, as well as any delivered by end-users, customers or other impacted third parties. Dealer will be compensated for executing the recall. Graham Field does not have direct access to end user names; however it plans to reach end-users by financially supporting a mailing from dealers to their individual customers notifying them of this recall. A follow up 60 day certified mailing will be performed for non-responders. The dealers will receive financial support for this second mailing. A secure third company will be contracted to hold for destruction all products affected by this recall. The method of destruction will be to cut the products into pieces, make them not usable. The FDA will be notified prior to the destruction of product and detailed logs and records will be maintained. Periodic effectiveness status report will be maintained for this recall.


  • Modelo / Serial
    Codes: Stock Code: 1#4, 3x 8mm, PO Number: 010707, 011512, 017479, 025991, 027823, 028364 and 029447; Stock Code: 1#5, 3 3/8 x 9mm, PO Number: 010707, 011512, 024048, 025151, 028364, 029447, 031261 and 034276; Stock Code: 1#7, 4 x 11 mm, PO Number: 011512, 020608, 023244, 031261, 033471 and 034276; Stock Code: 1#8, 4 ¿ x 12 mm, PO Number: 011512, 017756, 023244, 027339 and 033252; Stock Code: 1#9, 4 3/8 x 13 mm, PO Number: 011512 and 012479 and Stock Code: 1#10, PO Number: 010707 and 011512.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide distribution.
  • Descripción del producto
    John Bunn 1392 Series Jackson Tracheostomy Stainless Steel Tube.
  • Manufacturer


  • Dirección del fabricante
    Gf Health Products, Inc., 2935 Northeast Pkwy, Atlanta GA 30360
  • Empresa matriz del fabricante (2017)
  • Source