Events

Retiro De Equipo (Recall) de VITALTEMP General Purpose Probe

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 Vital Signs Colorado 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
    63532
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0407-2013
  • Fecha de inicio del evento
    2012-08-17
  • Fecha de publicación del evento
    2012-11-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-06-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114152
  • 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
    Probe, ent - Product Code KAK
  • Causa
    There is a potential for epistaxis during use of the disposable general purpose 9 french temperature probe.
  • Acción
    The firm,GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter and Confirmation form on August 17, 2012 via Fed Ex to its consignees/customers. The letter describes the product, problem and action to be taken. The customers were instructed to do the following: Do not use the Disposable General Purpose 9 French Temperature Probe P/N 1016 or 1016EU; return all unopened product(s) to Vital Signs Devices (VSD) 11039 East Lansing Circle, Englewood, CO 80112-note: replacements and/or refunds discussed in letter are available only in exchange for the return of any unopened product(s); complete and return the URGENT MEDICAL DEVICE CORRECTION CONFIRMATION via fax to: 800-535-7923; forward a copy of the letter to any institutions they may have forwarded the product and for customers using the GXXXXX64 kit that includes the Disposable General Purpose 9 French Temperature Probe follow the directions listed in the letter. Note: VSD is removing p/n 1016 and 1016EU, Disposable General Purpose 9 French Temperature Probe, from the market and offering a replacement. If you have any questions or concerns regarding this notification, contact Customer Service at +1-800-932-0760 (Domestic & International). Hours of Operation 8:00 am EST to 6:00 pm EST.

Device

VITALTEMP General Purpose Probe
  • Modelo / Serial
    Model Numbers 1016, 1016EU, R1016ES; GXXXX64 All units Made in Costa Rica are affected Lot Numbers:    12089A 12131A   5575A 5586X 5633U 5664E 5685G 5712T  12090B 12138A 5578K 5603R 5636Y 5666R 5685H  5714Z  12100A 12157B 5578L 5606U 5638P 5668N 5685J  12101B 12173A 5580Y 5614N 5638Q 5669G 5689Y  12102A 5573Q 5580Z 5615N 5648T 5669H 5691T  12108B 5574A 5581A 5621U 5648U 5671D 5692H  12109B 5574B 5581L 5623H 5653Z 5673V 5696Q  12114B 5574X 5583E 5631C 5658D 5683V 5700J  12117B 5574Y 5584C 5632V 5660C 5683W 5703N  12130B 5574Z 5584D 5633T 5664D 5683X 5708R
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) including states of: AR, CA, FL,GA, IL, LA, MA, MI, MO, NC, NH, NY, OH, OK, PA, RI, SE,TX, and WA; and countries of: AUSTRALIA, BARCELONA, GERMANY, NEW ZEALAND, NETHERLANDS, SWITZERLAND, and UNITED KINGDOM.
  • Descripción del producto
    Vital Signs Disposable General Purpose 9 French Temperature Probe || For monitoring of core temperature
  • Manufacturer
    Vital Signs Colorado Inc.

Manufacturer

Vital Signs Colorado Inc.
  • Dirección del fabricante
    Vital Signs Colorado Inc., 11039 East Lansing Circle, Englewood CO 80112-5909
  • Source
    USFDA