Events

Retiro De Equipo (Recall) de Device Recall Specimen Trap

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 Medline Industries 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
    66775
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1612-2014
  • Fecha de inicio del evento
    2013-11-04
  • Fecha de publicación del evento
    2014-05-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-11-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123381
  • 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
    Trap, sterile specimen - Product Code BYZ
  • Causa
    There is a potential that the specified mucus specimen traps are not sterile. use of the affected products may result in the contamination of patient specimens.
  • Acción
    Medline sent a Recall Notification Letters dated November 4, 2013 to all affected customers.The letters included instructions for customers to: check their stock of the affected products; complete and return the enclosed response form even if none of the recalled products are in inventory; Medline will provide customers with a Return Goods Authorization upon receipt of the response form and credit will be issued upon receipt of the returned recalled products; and, notify any customers who may have received the recalled products. Customers who have any questions can contact Medline Industries at 866-359-1704.

Device

Device Recall Specimen Trap
  • Modelo / Serial
    Model Numbers: DYND44140, DYND44140H, and DYND44180;   Purchase Order Number: 4506595929
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution in the states of CA, MA, MD, MI, MN, NH, NJ, NY, OH, PA, TX, and UT.
  • Descripción del producto
    Mucus Specimen Trap 40 cc, Specimen Trap 40 cc with additional transport cap; Product number DYND44140 (pack of 50), Product number DYND44140H (individual). Mucus Specimen Trap 80 cc, Specimen Trap 80 cc w/ additional transport cap; Product number DYND44180 (pack of 50). Used to collect mucus specimens during suction of fluid from the oral cavity, nose-throat area and/or bronchi of a patient.
  • Manufacturer
    Medline Industries Inc

Manufacturer

Medline Industries Inc
  • Dirección del fabricante
    Medline Industries Inc, 1 Medline Pl, Mundelein IL 60060-4485
  • Empresa matriz del fabricante (2017)
    Medline Industries Inc.
  • Source
    USFDA