Events

Retiro De Equipo (Recall) de Device Recall DeRoyal(R) TRAUMA CRANIOTOMY PACK

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 DeRoyal Processing Center.

¿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
    61038
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1003-2012
  • Fecha de inicio del evento
    2012-01-10
  • Fecha de publicación del evento
    2012-02-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-11-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107151
  • 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
    Tray surgical - Product Code LRP
  • Causa
    The firm distributed surgical kits which contained dermahook neuro elastic retractors which were subsequently recalled by teleflex.
  • Acción
    DeRoyal Industries sent a Customer letter dated January 6, 2012, to the affected customer. The letter identified the product the problem and the action needed to be taken by the customer. An email was also sent on January 10, 2012, to the affected customer. The customer was requested to follow these instructions. 1) Identify any affected inventory using the product and lot numbers on Attachment 1. 2) Attach the provided warning label to each affected kit and tray. 3) Forward this recall to any of your end users that may have affected product. 4) Complete and return Attachment 1 by fax (865-362-3716) or email (recalls@deroyal.com) within two weeks of the date of this letter, even if you no longer have affected inventory. If you have questions or need assistance with the recall, including additional labels, please call (865) 362-1037 . We apologize for any inconvenience this may caused you.

Device

Device Recall DeRoyal(R) TRAUMA CRANIOTOMY PACK
  • Modelo / Serial
    REF 89-7639.01 - Lot Number 24579045  REF 89-7639.01 - Lot Number 24664258  REF 89-7639.02 - Lot Numbers: 24828048, 25598985, 25359212, 25399676
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    (USA) including Indiana
  • Descripción del producto
    Custom surgical kits: || DeRoyal(R) TRAUMA CRANIOTOMY PACK, REF 89-7639.01, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849 || DeRoyal(R) TRAUMA CRANIOTOMY PACK PGYBK, REF 89-7639.01, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849 || DeRoyal(R) TRAUMA CRANIOTOMY PACK PGYBK, REF 89-7639.02, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849 || surgical kits
  • Manufacturer
    DeRoyal Processing Center

Manufacturer

DeRoyal Processing Center
  • Dirección del fabricante
    DeRoyal Processing Center, 1703 Highway 33 S, New Tazewell TN 37825-5043
  • Empresa matriz del fabricante (2017)
    Deroyal Industries Inc.
  • Source
    USFDA