Events

Retiro De Equipo (Recall) de Illumena 150mL Linden Luer Syringe (p/n 900103) & Illumena 150mL Regular Luer Syringe (p/n 900101)

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
    60874
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0830-2012
  • Fecha de inicio del evento
    2011-10-11
  • Fecha de publicación del evento
    2012-01-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-07-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106695
  • 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
    Injector, 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 illumena 150ml syringe with handi-fil straw, product 900101.
  • Acción
    The firm, Covidien, sent an "URGENT DEVICE RECALL" letter dated October 11, 2011 to their customers. The letter describes the product, problem and actions to be taken. The customers were instructed to check their inventory, if any of the affected lots are found, discontinue use of the lots immediately; complete and return the BUSINESS RESPONSE FORM even if they do not have any of the affected lots via fax to (314) 654-8206 or email to imaging.recalls@covidien.com by October 28, 2011; return product and notify any consignees that this product may have been distributed to. If you have any questions about this recall, contact our Product Monitoring department at 800-778-7898.

Device

Illumena 150mL Linden Luer Syringe (p/n 900103) & Illumena 150mL Regular Luer Syringe (p/n 900101)
  • Modelo / Serial
    Catalog # 900103 - Lot # 0253304, Exp Date. 09/2013; Lot # 0298222, Exp Date 10/2013; Lot # 0298223, Exp Date 10/2013; Lot # 0308031, Exp Date 11/2013; Lot # 0312202, Exp Date 11/2013; Lot # 0330293, Exp Date 11/2013; Lot # 0344197, Exp Date 12/2013; Lot # 0351244, Exp Date 12/2013; Lot # 0351245, Exp Date 12/2013; Lot # 1007208, Exp Date 01/2013; Lot # 1014335, Exp Date 01/2013; Lot # 1126136, Exp Date 05/2013; Lot # 1175144, Exp Date 06/2013; Lot # 1189159, Exp Date 07/2013 & Lot # 1203154, Exp Date 07/2013.  Catalog # 900101 - Lot #, 0314042, Exp Date, 11/2013; Lot #, 0323224, Exp Date, 11/2013; Lot #, 0356041, Exp Date, 12/2013; Lot #, 1007265, Exp Date, 01/2013; Lot #, 1119054, Exp Date, 04/2013 & Lot #, 1133140, Exp Date, 05/2013.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA (nationwide) including states of: AZ, CA, CT, DC, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI & WV; and countries of: Australia, Belgium, Brazil, Canada, Singapore, & Uruguay.
  • Descripción del producto
    Illumena 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103) & Illumena 150mL Regular Luer Syringe with Handi-Fil (p/n 900101), Made in Mexico, Liebel-Flarsheim Company, Cincinnati, OH || The Liebel Flarsheim Illumena 150mL Syringes with Handi-Fil Straw are 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.
  • Manufacturer
    Mallinckrodt Inc

Manufacturer

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