Events

Retiro De Equipo (Recall) de Medrad(R) Continuum MR Infusion System Primary VSA Stopcock Set

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 Medrad 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
    61734
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0599-2013
  • Fecha de inicio del evento
    2012-04-18
  • Fecha de publicación del evento
    2012-12-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-08-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108838
  • 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
    Set, administration, intravascular - Product Code FPA
  • Causa
    Bayer healthcare is recalling all medrad(r) continuum mf infusion system tubing sets (macrobore and microbore), catalog numbers mik200a, mil 200b, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. the firm is initiating this recall because this tubing exhibits a variation that, when used in conjunction with any continuum pump, may result in flow rate accuracy performance issues.
  • Acción
    The firm, Bayer HealthCare, sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 17, 2012 via the USPS certified mail to its consignees/customers. The firm expanded the recall on May 11, 2012 and sent a second letter entitled "EXPANDED URGENT MEDICAL DEVICE RECALL" to its affected consignees/customers notifying them of the additional issue. The letters described the product, problem and actions to be taken. The customers were instructed to return pump now; contact customer support at 1-877-229-3767 for a return goods authorization (RGA); complete and return Response Form, include RGA numbers, via Fax to Bayer Compliance at 412-4060942, and/or wait to return the pump when they begin contacting customers with this subset of pumps in August to make arrangements for a replacement pump. If you have questions, please contact our customer support team at 1-877-229-3767 or visit www.medrad.com for more information.

Device

Medrad(R) Continuum MR Infusion System Primary VSA Stopcock Set
  • Modelo / Serial
    Catalog number - Primary VSA Stopcock Set: 3015156. See firm's website - www.medrad.com for specific serial and lot numbers.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and countries of: Australia, Bermuda, Brazil, Canada, China, Chile, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Great Britain, Guam, Hong Kong, India, Israel, Italy, Japan, Korea, Lebanon, Mexico, Malaysia, Netherland, Poland, Portugal, Puerto Rico, Sweden, Singapore, Taiwan, Thailand, and Venezula.
  • Descripción del producto
    Medrad(R) Continuum MR Infusion System Primary VSA Stopcock Set || Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.
  • Manufacturer
    Medrad Inc

Manufacturer

Medrad Inc
  • Dirección del fabricante
    Medrad Inc, 1 Medrad Dr, Indianola PA 15051-9759
  • Source
    USFDA