Events

Retiro De Equipo (Recall) de SteriProbe Temperature 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 Cincinnati Sub-Zero Products 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
    60307
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0372-2012
  • Fecha de publicación del evento
    2012-01-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-08-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105007
  • 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
    temperature probe - Product Code BZT
  • Causa
    Reports that the rectal/ esophageal temperature probes are not reading correctly. this situation causes the blanketrol device, which the probes connect to, to shut down operation and display a 'check probe' error.
  • Acción
    Cincinnati Sub-Zero Products, Inc., issued an "Urgent Medical Device Field Action" letter on November 1, 2011 to all affected customers. The letter includes; description of product and problem, and a list of the affected lot numbers. The letter instructs the customers to discontinue use of the device. All unused product is to be returned to the Biomedical/Clinical Engineering and/or Service Department for an replacement and all used probes are to be disposed of in accordance with hospital policy. The customers are also instructed to complete and return an attached Recall Response Form ASAP. For additional information, customers may contact the Beatrice Washington at 1-800-989-7373 or (513) 772-8810.

Device

SteriProbe Temperature Probe
  • Modelo / Serial
    The following lot codes are subject to recall: 12998, 12999, 19257, 19257A, 19644, 21536, 21537, 27446, 29112, 31081, 31082, 32209, 37281, 38522,  8996, D414723, D416607, D420120, D421702, D423801, D423908, D525212, D515408, D516607, D517108, D520709, D524107, D525502, D527632, D530518, D624011, D624012, D634834 D706611, D709119, D720450, D721118, D722015, and D727416.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution and Canada.
  • Descripción del producto
    Cincinnati Sub Zero, Steri-Probe Temperature Probe, Esophageal/Rectal Temperature Probe, Part Number: 39622, Catalog #491B. TA disposable temperature probe used in conjunction with a measuring/monitoring device to continuously measure/monitor a patient's core body temperature.
  • Manufacturer
    Cincinnati Sub-Zero Products Inc

Manufacturer

Cincinnati Sub-Zero Products Inc
  • Dirección del fabricante
    Cincinnati Sub-Zero Products Inc, 12011 Mosteller Rd, Cincinnati OH 45241
  • Empresa matriz del fabricante (2017)
    Gentherm, Inc.
  • Source
    USFDA