Events

Retiro De Equipo (Recall) de Device Recall Arrowgard Blue Plus Antimicrobial Multilumen Central Venous 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
    67834
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1507-2014
  • Fecha de inicio del evento
    2013-07-17
  • Fecha de publicación del evento
    2014-04-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-06-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126460
  • 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,short-term less than 30 days - Product Code FOZ
  • Causa
    Arrow is recalling the arrowgard blue plus antimicrobial multi-lumen central venous catheter due to a labeling inconsistency. one portion of the lidstock states that the kit contains 8.5fr x 16cm catheter, while the rest of the lidstock correctly identifies the catheter as 8.5fr x 20cm.
  • Acción
    Arrow International Inc, ("Arrow") sent a Urgent Medical Device Recall Notification dated July 17, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 1. If you have affected stock, immediately discontinue use and quarantine any products with the catalog and lot number listed above. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to : 1-866-804-9881. Attn: Customer Service. This will allow us to document the amount of product you have on hand for return Goods Authorization (RGA) number and will provide instructions for the return of product to Arrow International. 3.If you have no affected stock please complete the enclosed Recall Acknowledgement Form and fax it to : 1-866-804-9881, Attn: Customer Service. This will allow us to document your receipt of this letter. For further questions please contact Arrow Customer Service at 1-800-343-2935.

Device

Device Recall Arrowgard Blue Plus Antimicrobial Multilumen Central Venous Catheter
  • Modelo / Serial
    lot RF2110924
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution including the states of IA, OR, WV, MI, AZ, IL, PA, GA, DE, NC, LA, and VA.
  • Descripción del producto
    Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter, catalogue number AK-45854-CDC.
  • 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