Events

Retiro De Equipo (Recall) de Device Recall NeoPICC 1.9 FR 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
    30528
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0349-05
  • Fecha de inicio del evento
    2004-11-24
  • Fecha de publicación del evento
    2005-01-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-06-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36060
  • 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, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
  • Causa
    Complaints of vessel erosion when using this product.
  • Acción
    The recalling firm issued a letter dated 11/23/04 to physicians informing them of the increase in complaints for vessel erosion and one death (at that time). On 12/3/04, the recalling firm issued a press release to alert the medical community of the problem and the need to return the device. The recalling firm issued a recall letter dated 12/7/04, to the Director of Purchasing, informing them of the adverse events associated with the use of the product and the need to return all of their inventory.

Device

Device Recall NeoPICC 1.9 FR Catheter
  • Modelo / Serial
    All lots higher than number 3231
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    The products were shipped to through specialty dealers/distributors to medical facilities nationwide. The product is also sold to government accounts and sales representatives. The product is also sold in Taiwan, Brazil, Hong Kong, Africia, and Canada.
  • Descripción del producto
    NeoPICC 1.9 FR Catheter. Percutaneous Implanted long term intravascular catheter. The product is shipped in cases of 5 units. Catalog numbers S1PIC1.9-S, S1PIC1.9-N, S1PIC1.9-SMK, and S1PIC1.9-C.
  • Manufacturer
    Arrow International Inc

Manufacturer

Arrow International Inc
  • Dirección del fabricante
    Arrow International Inc, 2400 Bernville Rd, Reading PA 19605-9607
  • Empresa matriz del fabricante (2017)
    Teleflex Incorporated
  • Source
    USFDA