Events

Retiro De Equipo (Recall) de Device Recall Nellcor CapnoProbe SLS1 sublingual Sensor

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 Nellcor Puritan Bennett.

¿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
    29892
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1414-04
  • Fecha de inicio del evento
    2004-08-24
  • Fecha de publicación del evento
    2004-09-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-12-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34735
  • 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
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase - Product Code CCK
  • Causa
    The product is contaminated with burkholderia cepacia (formally known as pseudomonas cepacia), based on the texas health department analysis and also firm's analysis.
  • Acción
    On 8/24/04 the firm issued letters via Fax to all its direct consignees, informing them of the affected product and providing instructions on the recall. The firm followed up with phone calls to all consignees completed by 8/25/04. The firm also issued a press release via Associated Press on 8/27/04.

Device

Device Recall Nellcor CapnoProbe SLS1 sublingual Sensor
  • Modelo / Serial
    All lots of the CapnoProbe are under recall. Each unit has a code number printed on the packaging.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The firm has distributed the sensors to 1 researcher in Europe, and 68 to direct customers (medical facilities) and 112 Field Sales Reps. Currently, there are no finished goods at the manufacturing site. 655 cases of product were disposed of at the distribution facility due to product expiration. The firm estimates 442 cases (3,536 units) to be in distribution channels.
  • Descripción del producto
    The probes involved have been part of the Nellcor¿ CapnoProbeTM SLS~1 Sublingual System. The CapnoProbe system consists of an N-80 CapnoProbe device and an SLS-1 Sublingual Sensor, or probe. Each probe is packaged in a metal canister filled with a nonsterile buffered saline solution. The canister is in a sealed foil envelope. Each disposable probe is used only one time.
  • Manufacturer
    Nellcor Puritan Bennett

Manufacturer

Nellcor Puritan Bennett
  • Dirección del fabricante
    Nellcor Puritan Bennett, 4280 Hacienda Dr, Pleasanton CA 94588-2719
  • Source
    USFDA