Events

Retiro De Equipo (Recall) de Device Recall pO2 D999 membrane units

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 Radiometer America 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
    67044
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0713-2014
  • Fecha de inicio del evento
    2013-06-10
  • Fecha de publicación del evento
    2014-01-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-06-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124601
  • 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
    Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
  • Causa
    Radiometer became aware that the regarded lot po2 units 942-042r0971 were produced with inner solution for pco2 membrane units. this solution is a salt solution similar to the po2 inner solution, but also contains glycerol which can be reduced at the cathode causing a suddenly rising zero current, causing the membrane unit to fail the following cal2 calibration.
  • Acción
    Radiometer sent a Product Notification letter dated June 18, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory and remove any affected product, discard all affected product in their possession, and complete page 2 of the letter and return to their Radiometer representative. Radiometer will replace any quantity of affected product they have at their location. Customers with questions were instructed to contact Radiometer America Technicial Support at 1-800-736-0600, opt 4. For questions regarding this recall call 440-871-8900, ext 209.

Device

Device Recall pO2 D999 membrane units
  • Modelo / Serial
    Part #: 942-042, Lot #: R0971
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) including states of: CO, CT, GA, MA, MO & MS and country of: Canada.
  • Descripción del producto
    pO2 D999 membrane units. Distributed by Radiometer America, Inc., Westlake, OH 44145 || pO2 membrane units, ordering number 942-042 Intended use is in vitro testing of samples of whole blood for pO2 (partial pressure of oxygen).
  • Manufacturer
    Radiometer America Inc

Manufacturer

Radiometer America Inc
  • Dirección del fabricante
    Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145-1521
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    USFDA