Events

Retiro De Equipo (Recall) de Device Recall Large Bore Central Venous Catheters

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
    52376
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1672-2009
  • Fecha de inicio del evento
    2009-05-08
  • Fecha de publicación del evento
    2009-08-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-07-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82810
  • 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
    Central Venous Catheters - Product Code FOZ
  • Causa
    Wire guide can have difficulty passing through catheter juncture hub or being removed from the catheter.
  • Acción
    The recalling firm issued an Urgent Medical Device Recall letter dated 5/11/09 to their customers informing them of the problem and the potential consequences. The letter asked customers to check their stock, cease use and distribution, and quarantine the affected products. They are to contact Arrow's Customer Service Department at 1-800-523-8446 for a Return Authorization Number; complete the Recall Acknowledgement & Stock Status Form and fax to 1-800-343-2935; and return any affected product. The letter states that Arrow can provide either replacement with a similar product at no charge or credit customers' accounts. Additional information or clarification can be obtained by calling Customer Service at 1-800-523-8446.

Device

Device Recall Large Bore Central Venous Catheters
  • Modelo / Serial
    Product numbers AK-15123-H - Lot numbers: RF8020142, RF8029122, RF8031799, RF8045050, RF8084251, RF8123397, RF9027126, and RF9039409; Product numbers AK-15123-J - Lot numbers: RF8031856, RF8056908, and RF8071778; Product numbers CS-15123-E - Lot numbers: RF8044326, RF8071238, RF8097152, RF9014658, RFZF8027313, ZF8027652, ZF8037872, ZF8048327, ZF8058745, ZF8069575, ZF8070317, ZF8079993, ZF8080559, ZF8091380, ZF8113337, ZF8123891, ZF9014736, ZF9014737, ZF9014797, ZF9025529, ZF9035668; and Product numbers MC-15123 - Lot numbers: RF8044327, RF8069574, RF8084830, RF9016649, and RF9039995.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, Belgium, Canada, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Hungary, Indonesia, Ireland, Israel, Italy, Lithuania, Japan, Republic of Korea, Netherlands, New Zealand, Poland, Singapore, Slovakia, South Africa, Spain, Taiwan, Ukraine, and United Kingdom.
  • Descripción del producto
    12 French 3 Lumen 20 cm Large-Bore Central Venous Catheters. Product numbers AK-15123-H, AK-15123-J, CS-15123-E, and MC-15123. || The large-bore multiple-lumen catheter permits venous access to the central circulation for rapid fluid administration. It may be inserted into the jugular, subclavian, or femoral veins.
  • 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