Events

Retiro De Equipo (Recall) de Device Recall BLOMSINGER indwelling TEP Occluder

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 Helix Medical LLC.

¿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
    62970
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-2336-2012
  • Fecha de inicio del evento
    2012-03-08
  • Fecha de publicación del evento
    2012-09-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-04-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112155
  • 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
    Prosthesis, laryngeal (taub) - Product Code EWL
  • Causa
    Helix medical llc is recalling the blom-singer indwelling tep occluder due to an invalid expiration date.
  • Acción
    A recall letter dated March 8, 2012, was sent to customers who purchased the Blom-Singer Rapid Response Voice Prosthesis TEP Occluder 4mm 20Fr. (IN2004-TO). The letter informed the customers of the problem identified and the action to be taken. Customers were instructed to contact Customer Service Center at (800) 477-5969 if they have products to be returned. Customers were instructed to return Blom-Singer Rapid Response Voice Prosthesis TEP Occluder 4mm 20Fr. (IN2004-TO) to: Helix Medical, LLC Attn to: Customer Service-IN2004-TO. 1110 Mark Avenue Carpinteria, CA 93013 For questions regarding this recall call 805-684-3304.

Device

Device Recall BLOMSINGER indwelling TEP Occluder
  • Modelo / Serial
    Lot#1008419
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) including state of: Ohio and country of United Kingdom
  • Descripción del producto
    BLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO || The Blom-Singer Indwelling (TEP(tracheoesophageal Puncture) Occluder is a non-valved silicone prosthesis designed for placement in and maintenance of the TE (tracheoesophageal) puncture following total laryngectomy. The Blom-Singer Indwelling TEP (tracheoesophageal Puncture) Occluder is indicated for placement in and maintenance of the TE puncture following total laryngectomy when placement, or replacement, of an indwelling prosthesis is performed by a qualified, trained medical professional.
  • Manufacturer
    Helix Medical LLC

Manufacturer

Helix Medical LLC