Retiro De Equipo (Recall) de Centurion

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 Centurion Medical Products Corporation.

¿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
    70081
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0943-2015
  • Fecha de inicio del evento
    2014-10-23
  • Fecha de publicación del evento
    2015-01-08
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2015-06-08
  • Fuente del evento
    USFDA
  • 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
    Nerve block tray (kit) - Product Code OGJ
  • Causa
    According to the recall notice received from hospira, the recall was initiated due to a confirmed customer report of particulate in a single unit. hospira identified the particulate as human hair, embedded in and attached to a pinched area of the stopper.
  • Acción
    Centurion sent an Urgent Product Recall Notice dated October 23, 2014, to al affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify and remove all affected inventory that may be in their possession and to forward a copy of thie noctice to any cusotmers to whom the affected product may have been further distributed. Customers were asked to complete the enclosed accountability record whether not they have the product and fax to 517-546-3356. Customers with questions were instructed to call 517-546-5400 Ext. 1135. For questions regarding this recall call 517-546-5400, ext 1135.

Device

  • Modelo / Serial
    CMP Kit code: DT13405 Lot numbers: 2014061250 and 2014071750 Expiration date lot 2014061250: 2016-02  Expiration date lot 2014071750: 2016-03
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including MA, IN, NY, GA, AL, PA, and RI.
  • Descripción del producto
    Nerve Block Tray (Nerve Block convenience kit)
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Centurion Medical Products Corporation, 100 Centurion Way, Williamston MI 48895-9086
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA