Events

Retiro De Equipo (Recall) de Device Recall Tego Connector

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 ICU Medical, 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
    75093
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0988-2017
  • Fecha de inicio del evento
    2016-08-24
  • Fecha de publicación del evento
    2017-01-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-07-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149342
  • 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
    Set, administration, intravascular - Product Code FPA
  • Causa
    Icu medical inc. has identified a potential risk of leaking with certain tego connector devices.
  • Acción
    The firm, icumedical, sent an "URGENT: Medical Device Recall Notification" letter dated 8/24/16 to all their customers. The letter describes the product, problem and actions to be taken. The customers were instructed to quarantine any affected devices; remove from use, return to ICU medical, Inc.; and complete and return the recall response form to ICU Medical via fax (801) 264-1755 or at recall@icumed.com (even if you do not have any affected product). Customers with questions are instructed to contact ICU customer service Monday through Friday between 8:30AM and 4:00PM Pacific Time, (866) 829-9025 and select option 8 or email the following: customerservice@icumed.com.

Device

Device Recall Tego Connector
  • Modelo / Serial
    3239841 3239848 3244021 3244022 3244023 3244558 3244560 3246196 3254636 3255850 3258004 3258326 3258327 3260656 3261516 3261517 3265975 3268523 3269593 3269594 3275467 3278966 3278967 3224799
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-US: (Nationwide) and countries of: Saudi Arabia, Germany, Austria, Belgium, Estonia, Poland, Switzerland, Canada, Luxembourg, Netherlands, Bulgaria, Malaysia, Italy, Ireland, Great Britain, France, Brazil, Sweden, Slovenia, and Portugal.
  • Descripción del producto
    Tego Connector, Item No. D1000, NM1000 || The Tego¿ Needle Free Access Device is intended for use as an accessory to a vascular access device (catheter) used in Hemodialysis or as an accessory to an Intravascular Administration Set for the administration or withdrawal of fluids to a patient through a cannula or needle placed in the vein or artery. The Tego¿ is a needle-free capping device which closes the end of the catheter. The Tego¿ will permit access to the catheter without the use of needles and therefore passively aid in the reduction of needle stick injuries.
  • Manufacturer
    ICU Medical, Inc.

Manufacturer

ICU Medical, Inc.
  • Dirección del fabricante
    ICU Medical, Inc., 951 Calle Amanecer, San Clemente CA 92673-6212
  • Empresa matriz del fabricante (2017)
    ICU Medical, Inc.
  • Source
    USFDA