Events

Retiro De Equipo (Recall) de Device Recall Arrow Super ArrowFlex(R) Percutaneous Sheath Introducer 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 Arrow International 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
    57572
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0936-2011
  • Fecha de inicio del evento
    2010-12-20
  • Fecha de publicación del evento
    2011-01-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-09-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96674
  • 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
    Introducer, catheter - Product Code DYB
  • Causa
    Packaging may have been compromised, and sterility of product cannot be guaranteed.
  • Acción
    The firm, Teleflex Medical thru its subsidiary Arrow International, Inc., sent an "Urgent Field Safety Notice" letter dated December 20, 2010, with Field Acknowledgement form to all customers. The letter described the product, problem and action to be taken by the customers. The letter instructed the customers to check their stock for affected product, cease use and distribution of product and quarantine all products from affected lot immediately; contact their local Teleflex Medical Customer Service/Sales Rep (or Distributor) for a return authorization number prior to filling out the FIELD SAFETY CORRECTIVE ACTION ACKNOWLEDGEMENT AND STOCK STATUS FORM; and complete and return the form immediately by email. If you do not have the product from the affected lot, indicate it on the form and fax it to your local Teleflex Medical Customer Service/Sales Rep (or Distributor). The Teleflex Medical Customer Service/Sales Rep (or Distributor) will coordinate the product return with the customer. If you have any questions, please contact the Regulatory Affairs Project Manager at 610-378-0131 ext 3318 or email: Jody.Cadd@teleflexmedical.com.

Device

Device Recall Arrow Super ArrowFlex(R) Percutaneous Sheath Introducer Set
  • Modelo / Serial
    Part No: CL-07645, Lot No: CF0014630
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    International distribution only: countries include: Austria, Belgium, Czech Republic, Germany, Greece, Italy, and Luxembourg.
  • Descripción del producto
    Super Arrow-Flex(R) PSI Set || Intended for use in the hospital catheterization laboratory for the percutaneous introduction of various devices into veins and/or arteries in a variety of diagnostic and therapeutic procedures
  • Manufacturer
    Arrow International Inc

Manufacturer

Arrow International Inc
  • Dirección del fabricante
    Arrow International Inc, 2400 Bernville Road, Reading PA 19605
  • Empresa matriz del fabricante (2017)
    Teleflex Incorporated
  • Source
    USFDA