Events

Retiro De Equipo (Recall) de Device Recall ArrowHowes (TM) Multi Lumen Central Venous Catheterization Set with Blue FlexTip(R) 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 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
    57218
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0898-2011
  • Fecha de inicio del evento
    2010-11-09
  • Fecha de publicación del evento
    2011-01-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-09-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95621
  • 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
    Percutaneous Catheter - Product Code DQY
  • Causa
    One lot of product was inadvertently mislabeled with a product lidstock identifying the product as a triple-lumen catheter with product number cv-15703, but a double-lumen catheter with part number cv-16702 was actually packaged in the kit.
  • Acción
    The recalling firm issued Urgent Medical Recall letters dated 11/9/10 to inform their customers of the problem and the need to return any unused product. Customers are to check their stock for the affected product, contact Arrow Customer Service for a Return Authorization Number, and complete the enclosed Recall Acknowledgement & Stock Status Form. For customers with no affected product in stock, the form should still be completed and also faxed to Arrow Customer Service. Affected product should be returned along with the original completed form to Arrow International, Inc. Arrow will replace the affected product once it has been returned. Additional information or clarification can be obtained from Arrow Customer Service at 1-919-361-3964.

Device

Device Recall ArrowHowes (TM) Multi Lumen Central Venous Catheterization Set with Blue FlexTip(R...
  • Modelo / Serial
    Lot/Serial Number: CF9065974.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    International Distribution Only -- Argentina and Columbia.
  • Descripción del producto
    Arrow-Howes (TM) Multi Lumen Central Venous Catheterization Set with Blue FlexTip(R) Catheter. Catalog #: CV-15703. || Permits venous access to the central circulation.
  • 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