Events

Retiro De Equipo (Recall) de Device Recall Dressing Change Tray

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
    57767
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1464-2011
  • Fecha de inicio del evento
    2011-01-14
  • Fecha de publicación del evento
    2011-03-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-06-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97367
  • 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
    Kit, wound dressing - Product Code MCY
  • Causa
    The firm is conducting a subrecall of kits containing triad groups alcohol prep pads. triad initiated a recall of prep pads due to a concern about potential contamination of the products with an objectional orgainism, bacillus cereus.
  • Acción
    The firm, Centurion Medical Products, sent an "URGENT PRODUCT RECALL NOTICE" dated January 12, 2011 to affected customers via Certified Mail, Return Receipt Requested. The notice described the product, problem and action to be taken. The customers were instructed to identify and remove all inventory of the recalled kits in their possession; forward a copy of this notice to any customers that this product was further distributed to, and complete and return the attached Accountability Record form via fax to 517-546-3356 or email to: lcarpenter@centurionmp.com. The notice states that a Centurion representative will contact them regarding retrieval of the product from the facility. Should your require additional information, please contact the Director of Quality Assurance & Regulatory Affairs at (517) 546-5400 ext. 1135.

Device

Device Recall Dressing Change Tray
  • Modelo / Serial
    2010070590
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: USA including state of: CT, ID, NM, MA, MO, MT, VA and SC.
  • Descripción del producto
    Dressing Change Tray, DT12770, Sterile, Centurion Medical Products Corp., Williamston, MI. || These kits are used for dressing changes.
  • Manufacturer
    Centurion Medical Products Corporation

Manufacturer

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