Events

Retiro De Equipo (Recall) de Device Recall DuraHook Neuro Elastic Retractors

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 Teleflex Medical.

¿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
    60619
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0677-2012
  • Fecha de inicio del evento
    2011-12-06
  • Fecha de publicación del evento
    2012-01-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-05-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105992
  • 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
    Hook, surgical, general & plastic surgery - Product Code GDG
  • Causa
    Teleflex medical received complaints that the elastic bands are breaking, cracking and /or deteriorating prior to their expiration date. if the elastic bands break during use there is a chance for operative exposure, loss of the band in the operative field as well as inadvertent needle stick.
  • Acción
    The firm, Teleflex Medical, sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated December 6, 2011 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately discontinue distribution and quarantine any products with the listed catalog and lot numbers; communicate this recall to any of their customers who have received the product; have their customers return the affected product together with a completed Recall Acknowledgement Form to Teleflex Medical, if an alternative approach is needed, contact Teleflex Medical Customer Service for more information at 1-866-246-6990; complete and return the Recall Acknowledgement Form via fax to 1-866-804-9881, Attn: Customers Service even if they and their customers have no affected stock. If you have any questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.

Device

Device Recall DuraHook Neuro Elastic Retractors
  • Modelo / Serial
    Catalog numbers: 382800, Lot numbers: 01A1100009, 01A1100165, 01A1100251, 01A1100355, 01B1100028, 01B1100274, 01E1000297, 01F1000587, 01F1000588, 01F1000589, 01G1000138, 01G1000327, 01G1000433, 01G1000512, 01H1000112, 01H1000297, 01J1000548, 01K1000182, 01M1000218, 01M1000326 and 01M1000339.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution.
  • Descripción del producto
    Weck, DuraHook ¿ (6mm) and ¿ (12mm), Neuro Elastic Retractors, 6 per Package, 10 Packages per Sales Units, 10 Sales Units per Shipper, Rx Only, Teleflex Medical, Research Triangle Park, NC 277809. || For use as skin retraction devices during general surgery. DuraHooks are also cleared for use in procedures requiring retraction of dura mater.
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Dirección del fabricante
    Teleflex Medical, 2917 Weck Dr., Research Triangle Park NC 27709
  • Empresa matriz del fabricante (2017)
    Teleflex Incorporated
  • Source
    USFDA