Events

Retiro De Equipo (Recall) de Device Recall SmarTemp Probe Covers

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 Mindray DS USA, Inc., dba Datascope Patient Monitoring.

¿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
    54175
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1396-2010
  • Fecha de inicio del evento
    2009-12-31
  • Fecha de publicación del evento
    2010-04-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-12-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87764
  • 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
    System, measurement, blood-pressure, non-invasive - Product Code DXN
  • Causa
    Smartemp disposable probe covers may contain microscopic holes in the molded seam that would allow liquids or body fluids inside the cover and potentially contaminate the temperature probe.
  • Acción
    Mindray DS USA, Inc. issued an "Urgent Product Recall" notification dated December 31, 2009 by certified mail. Consignees were informed of the affected product and requested to discard all remaining stock. Replacement product will be provided by the firm at no cost. For further information, contact Mindray DS USA, Inc. at 1-201-995-8000.

Device

Device Recall SmarTemp Probe Covers
  • Modelo / Serial
    All lots of the following product numbers: 1. M09A-20-62124 Covers, Temp Probe- box of 20 probes and M09A-30-62128 Covers, Temp Probe - box of 2000 (10 boxes of 200)  2. A box of 20 Disposable Probe Covers (part number M09A-20-62124) are also included in the following kits:  0020-00-0192 - SmarTemp Module Kit and 6006-30-39590 - SmarTemp Temperature Probe Kit.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- United States, Canada and Australia. Nationwide distribution to hospitals, medical facilities and distributors as well as to Canada and Australia.
  • Descripción del producto
    SmarTemp Probe Covers with the Accutorr V Monitor; Rx only. Mindray DS USA, Inc. Mahway, NJ 07430. Packaged in boxes of 20, Model ST010, also distributed in boxes of 2000 (10 individual boxes of 200); SmarTemp Module Kit (contains one box of 20 probes) and SmarTemp Temperature Probe Kits (contains one box of 20 probes). || Probe Cover for use with the SmarTemp Reusable Temperature Probe.
  • Manufacturer
    Mindray DS USA, Inc., dba Datascope Patient Monitoring

Manufacturer

Mindray DS USA, Inc., dba Datascope Patient Monitoring