Events

Retiro De Equipo (Recall) de Device Recall Crosser 14S Catheter

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 Flowcardia 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
    50791
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0938-2011
  • Fecha de inicio del evento
    2009-01-09
  • Fecha de publicación del evento
    2011-01-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-01-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77308
  • 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
    Catheter, percutaneous - Product Code DQY
  • Causa
    Mislabeled expiration date: some units were mislabeled with a three year shelf life, but the product is validated only for a two year shelf life.
  • Acción
    The firm, FlowCardia, Inc., sent an "URGENT! Medical Device Recall" letter dated January 9, 2009 to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to return the product to FlowCardia, at the firms expense, for replacement and Confirm that this product has been used by completing and returning the attached fax document via fax to 408-616-0053. The customers were ask to please make an attempt to contact the customer service representatives, Operations specialist at 888-456-7286 or Vice President, Clinical, Quality & Regulatory Affairs at 408-617-0352 x302, within the next 30 days. Note: FlowCardia Sales, Clinical and Customer support will send notification via certified mail or traceable courier and track response. If you have any questions or need any additional information email (dmichaels@flowcardia.com) or telephone at 408-617-0352 x302. Alternatively you may contact customer service at 888-456-7286.

Device

Device Recall Crosser 14S Catheter
  • Modelo / Serial
    labeled shelf life code 2011-12, lot number 5053
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: CA, NJ, LA, TX, GA, MI and CO.
  • Descripción del producto
    Crosser 14S Catheter, Catalog/REF CRU14S, Lot number 5053 manufactured by Flowcardia Inc, Sunnyvale, CA || Intended use: Catheter for use in surgery.
  • Manufacturer
    Flowcardia Inc.

Manufacturer

Flowcardia Inc.
  • Dirección del fabricante
    Flowcardia Inc., 745 N Pastoria Ave, Sunnyvale CA 94085-2918
  • Empresa matriz del fabricante (2017)
    Becton, Dickinson and Company
  • Source
    USFDA