Events

Retiro De Equipo (Recall) de Device Recall MicroFuel Cell Oxygen Sensor, Class RI5

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 Teledyne Instruments - Analytical Instruments.

¿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
    58322
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3001-2011
  • Fecha de inicio del evento
    2010-11-29
  • Fecha de publicación del evento
    2011-08-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-08-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98984
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Notas adicionales en la data
  • Causa
    The recall was initiated because during a test on a batch of sensors on the company shipping dock, teledyne instruments discovered electrolyte loss from the sealing cylinder on a few sensors. this test was done pursuant to a complaint from one customer of label discoloration caused because of the electrolyte loss. the risk of a leak form the oxygen sensor while in use is the disruption of therape.
  • Acción
    Teledyne Instruments sent emails and "Urgent--Device Field Corrections/Removal" letters in December 2010 to all affected customers. Th letter includes description of device and problem. Customers are advised to check them before use for any signs of electrolyte loss and if discoloration is noted to discontinue its use. and provides recommendation. Teledyne-desplaines to generate a product field corrections/removal log that lists names/addresses of the consignees, quantity of sensors shipped, sensor serial numbers and the date of shipment. For additional information or questions contact Teledyne Instruments at (626) 934-1504.

Device

Device Recall MicroFuel Cell Oxygen Sensor, Class RI5
  • Modelo / Serial
    Sensor Part Number: C41131-R15. Serial Numbers: 593875 to 593894 (20), 599156 to 599254(99), 611100 to 611599 (500), 617125 to 617674(550), 642023 to 642472 (450), 642474 to 642475 (2), 642485 to 643022 (538), 666158 to 666657 (500), 668499 to 668647 (149), and 668652 to 668656 (5).
  • Clasificación del producto
    Anesthesiology Devices
  • Distribución
    Worldwide Distribution: Nationwide (US) distribution including the states of CA, TN and WI; and the countries of , Canada, Brazil, Chile, Saudi Arabia, and the U.K.
  • Descripción del producto
    Micro-Fuel Cell Oxygen Sensor, Class RI5 || Sensor Part Number: C41131-R15 || Teledyne Instruments - Analytical Instruments || Disposable oxygen sensors with limited useful life. These sensors are accessories to other oxygen diagnostic devices, and are not in themselves suitable for therapeutic use.
  • Manufacturer
    Teledyne Instruments - Analytical Instruments

Manufacturer

Teledyne Instruments - Analytical Instruments
  • Dirección del fabricante
    Teledyne Instruments - Analytical Instruments, 16830 Chestnut St, City Of Industry CA 91748-1017
  • Source
    USFDA