Events

Retiro De Equipo (Recall) de Centurion Sterile 84 Rubber Bands

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
    66830
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0464-2014
  • Fecha de inicio del evento
    2013-10-28
  • Fecha de publicación del evento
    2013-12-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-01-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123693
  • 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
    Device, general medical - Product Code LDQ
  • Causa
    Package labeling indicates both "latex free" and "contains natural rubber latex" . the rubber bands do contain natural rubber latex. this could cause a significant risk to users with latex allergies.
  • Acción
    Centurion sent a Urgent Recall Notification letter via Certified Mail October 31, 2013, return receipt to all affected customers. The affected Centurion Medical Products Corporation sales representatives were notified via email on October 28, 2013. Customers were instructed to destroy all implicated product and complete the accountability record included with the notice and fax to 517-546-3356. Customers were asked to forward a copy of the notice if product was further distributed. Additional notices will be mailed to non-responsive customers via Certified Mail Return Receipt, and will be documented in the recall file. For further questions please call (517) 546-5400.

Device

Centurion Sterile 84 Rubber Bands
  • Modelo / Serial
    EB84, Lot 2013041801 Expriation 2018/03
  • Distribución
    US Distribution including the states of GA, LA and NY.
  • Descripción del producto
    Centurion Sterile # 84 Rubber Bands Reorder EB84, Caution: This product contains natural rubber latex which may cause allergic reactions. || LATEX FREE , CAUTION: FEDERAL lAW (USA) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN || Single Use Only || bands items together and podiatry office uses bands as tourniquet on toe during in grown toenail procedure
  • Manufacturer
    Centurion Medical Products Corporation

Manufacturer

Centurion Medical Products Corporation
  • Dirección del fabricante
    Centurion Medical Products Corporation, 301 Catrell Dr, Howell MI 48843-1703
  • Empresa matriz del fabricante (2017)
    Medline Industries Inc.
  • Source
    USFDA