Events

Retiro De Equipo (Recall) de Device Recall Angiomat Illumena Syringe, 150mL Linden Luer Syringe with HandiFil Straw (p/n 900103)

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 Mallinckrodt 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
    59103
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2859-2011
  • Fecha de inicio del evento
    2011-05-20
  • Fecha de publicación del evento
    2011-07-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101150
  • 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
    Injection, contrast medium, automatic - Product Code IZQ
  • Causa
    Syringes packaged and labeled as the illumena 150ml linden luer syringe with handi-fil straw, product 900103, contained the illumena150ml syringe with handi-fil straw, product 900101.
  • Acción
    COVIDIEN sent an Urgent Device Recall letter dated May 20, 2011 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to use the attached business response form and report the quantity of lot number 0253304 currently in their stock. If the customer did not have any of the affected lot they were to indicate by checking the appropriate box on the form. When completed, customers were asked to fax to (314) 654-8206 or email to productmonitoringhazelwood@covidien.com. All product from lot number 0253304 was to be returned to Covidien. Once the business notification form is received a Return Goods Authorization for the quantity of product reported will be sent to the customer. Customers would receive credit for all return product from affected lot. For any questions regarding this recall customers were asked to contact the Product Monitoring department at 800-778-7898. For questions about credit for the product, call Customer Service at 888-744-1414, menu option 1, and then menu option 2.

Device

Device Recall Angiomat Illumena Syringe, 150mL Linden Luer Syringe with HandiFil Straw (p/n 900103)
  • Modelo / Serial
    Lot number - 0253304, Part No. 900103
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including CA, FL, IL, IN, MI, MO, NY, OH, TN & TX. and the country of Australia.
  • Descripción del producto
    Angiomat Illumena Syringe, 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103), in a sealed molded plastic tray. || The Liebel Flarsheim Illumena 150 mL Linden Luer Syringe with Handi-Fil Straw is designed for use with the Illumena Injector System. The Angiomat Illumena is designed to inject a radiopaque contrast medium into the vascular system for Angiographic or CT procedures as prescribed by qualified health care professionals.
  • Manufacturer
    Mallinckrodt Inc

Manufacturer

Mallinckrodt Inc
  • Dirección del fabricante
    Mallinckrodt Inc, 2111 E Galbraith Rd, Cincinnati OH 45237-1624
  • Source
    USFDA