Events

Retiro De Equipo (Recall) de Device Recall Triton Administration Sets

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 WalkMed Infusion, LLC.

¿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
    74437
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2224-2016
  • Fecha de inicio del evento
    2016-06-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-12-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147535
  • 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
    Set, administration, intravascular - Product Code FPA
  • Causa
    Walkmed infusion, llc announces a voluntary field action of multiple triton administration sets due to the potential presence of particulate in or on the administration sets.
  • Acción
    Terumo sent a notification letter dated June 8, 2016 to customers. The letter identified the affected product, problem and action to be taken. Customers were instructed to 1. Review this notice and ensure that all users receive notice of this issue. 2. Return the attached Customer Response Form acknowledging receipt of this notice. 3. Source a replacement for the Interchlor sanitizer. See information above or call Terumo CVS Technical Support for assistance. 4. Terumo CVS will provide users with updated user instructions regarding the 10% Sodium Hypochlorite sanitization solution. Instructions will be provided under separate cover, when available. For questions contact your Terumo representative or contact Terumo CVS Technical Support at 800.441.3220, extension 6932.

Device

Device Recall Triton Administration Sets
  • Modelo / Serial
    Product Number: 020-300198. Lot Number: 1406083, 1406084, 1406085, 1406086, 1407014, 1407015, 1407118, 1407119, 1408129, 1408130, 1410072D, 1410073D, 1412059D, 1501062D, 1501106D, 1503048D, 1503049D, 1506064D
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution in the states of AL, AZ, CA, FL, IL, MA, MS, NJ, NV, NY, OH, PA, TN, UT, and WA.
  • Descripción del producto
    T090-000V 90" 20 Drop IV Admin Set w/ Needlefree Y-Site. Packaged in a Tyvek pouch, with 50 pouches per case. || Product Usage: || Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.
  • Manufacturer
    WalkMed Infusion, LLC

Manufacturer

WalkMed Infusion, LLC
  • Dirección del fabricante
    WalkMed Infusion, LLC, 6555 S Kenton St Ste 304, Englewood CO 80111-6838
  • Empresa matriz del fabricante (2017)
    Walkmed Infusion LLC
  • Source
    USFDA