Retiro De Equipo (Recall) de Device Recall suction canister

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 Industries 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
    Bottle, collection, vacuum - Product Code KDQ
  • Causa
    These lots of suction canisters and lids have an insufficient seal under low or intermittent suction condition.
  • Acción
    DeRoyal sent an Urgent Voluntary Recall letter dated August 22, 2014, to all affected consignees by overnight letter or by email. DeRoyal was to follow up with non-responding accounts before October 1, 2014. Customers were instructed to check their inventory for the affected product. If they have affected product, customers were instructed to destory both the liner and the lid and dispose of it according to their facility's procedures. Customers were instructed to return the included Notice of Destruction to even if they no longer have affected product. Customers with questions were instructed to contact their DeRoyal Sales Representative or DeRoyal Customer Service at 1-800-251-9864. For questions regarding this recall call 865-362-2334.


  • Modelo / Serial
    1) DeRoyal(R), REF 71-6510, Lot 36408631  2) NOVAPLUS(TM) Cat. No. V71-6510, Lot 36408622
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide Distribution including MI, OH, IN, FL, WV, VA, MI, NC, and NY
  • Descripción del producto
    Suction canisters labels as follows: || 1) DeRoyal(R) SUCTION CANISTER, 1000cc, SEMI-RIGID, REF 71-6510, NON-STERILE, Rx Only. || 2) NOVAPLUS(TM) SUCTION CANISTER, 1000 cc, SEMI-RIGID, Cat. No. V71-6510, NON-STERILE, Rx Only || general hospital
  • Manufacturer


  • Dirección del fabricante
    DeRoyal Industries Inc, 200 Debusk Ln, Powell TN 37849-4703
  • Empresa matriz del fabricante (2017)
  • Source