Events

Retiro De Equipo (Recall) de Ethicon

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 Ethicon, 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
    Recall
  • ID del evento
    62056
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1897-2012
  • Fecha de inicio del evento
    2012-04-03
  • Fecha de publicación del evento
    2012-06-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-04-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109783
  • 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
    Agent, absorbable hemostatic, collagen based - Product Code LMF
  • Causa
    The lyophilized thrombin component of the surgiflo hemostatic matrix kit with thrombin has the potential to be non-sterile due to an undetected air leak which occurred during the manufacturing process.
  • Acción
    Ethicon Inc. sent a Urgent Voluntary Product Recall letter dated April 3, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. If you have any product subject to this voluntary recall, please remove it from your inventory immediately and return it per the following instructions. Return product to Stericycle using the enclosed pre-paid shipping label. Shipping fees wil be charged directly to Ethicon through the use of this shipping label. No reimbursements will be made for the shipping charge if this label is not used. Extra shipping labels may be obtained by calling 1-866-338-2611. Credit will be issued for impacted product that is returned. Further questions please call 1-866-338-2611, or contact your Ethicon Biosurgery Sales Representative. Thank you for your coorporation and immediate assistance. .

Device

Ethicon
  • Modelo / Serial
    D100622   Product Code Lot Number Expiration Date  199102S 237115 8/31/2012 199102S 238568 9/30/2012 199102S 238569 11/30/2012 199102S 237493 6/30/2012 2993 235489 11/30/2012 2993 238599 3/31/2013 2993SAMP 238369 3/31/2013 SAMP199102S 237493 6/30/2012 SAMP199102S 283569 11/30/2012
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    USA (nationwide)
  • Descripción del producto
    Ethicon Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip || Distributed by Ethicon Ethicon Inc., Somerville, NJ 08876 USA || Manufactured by Ferrosan Medical Devices || Ferrosan Medical Devices A/S || Sydmarken 5, DK-2860 Soeberg, Denmark || Mixed with sterile saline or thrombin solution is indicated for surgical procedures (except opthalmic) for hemostasis when control of capillary, venous and arteriolar bleeding by pressure, ligature, and other conventional procedures is ineffective or impractical.
  • Manufacturer
    Ethicon, Inc.

Manufacturer

Ethicon, Inc.
  • Dirección del fabricante
    Ethicon, Inc., US Highway 22 West, Somerville NJ 08876
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA