Events

Retiro De Equipo (Recall) de Device Recall Pall "TNA1" Total Nutrient Admixture Filter

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 Pall Life Sciences Puerto Rico 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
    59174
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2715-2011
  • Fecha de inicio del evento
    2011-06-15
  • Fecha de publicación del evento
    2011-06-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-01-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101496
  • 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
    Filter, infusion line - Product Code FPB
  • Causa
    Incorrect filter media used (0.2 um filter used instead of the required 1.2 um) within the tna1 filter used with total parenteral nutrition mixtures.
  • Acción
    Pall Life Sciences LLC, sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 15, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter instructed customers to maintain the product in quarantine. If distributed, the letter request that customers notify the user to discontinue use. Additionally, customers were asked to complete and return an attached Recall Response Form. The letter also included instructions on how to return the product. Please contact the Customer Service Department at 516-801-9923, if you have questions.

Device

Device Recall Pall "TNA1" Total Nutrient Admixture Filter
  • Modelo / Serial
    Exp. date 2015-07: Lots 032711, 032811, 033611 and 033711 Exp. date 2016-01: Lots 105912 and 106012
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution--USA (nationwide) including the states of CA, CO, CT, IL, KS, LA, MA, MO, MS, NC, NY, OK, SD, TX, WA, and WY, and Puerto Rico and the countries of Colombia and Costa Rica.
  • Descripción del producto
    Pall Total Nutrient Admixture Filter, 1.2 micron filter || This filter is a 1.2 micron low protein binding membrane indicated for the removal of inadvertent particulate debris and microorganisms (Candida Albicans) from total nutrient admixtures and undiluted intravenous fat emulsions. Product is designed for use with intravenous infusion pumps only.
  • Manufacturer
    Pall Life Sciences Puerto Rico Llc

Manufacturer

Pall Life Sciences Puerto Rico Llc
  • Dirección del fabricante
    Pall Life Sciences Puerto Rico Llc, Pall Blvd 99 & 100, Rd 194, Km 0.4, Fajardo PR 00738
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    USFDA