Events

Retiro De Equipo (Recall) de Device Recall Compat Nasogastric Feeding Tube

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 Nestle HealthCare Nutrition.

¿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
    65781
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1922-2013
  • Fecha de inicio del evento
    2013-07-24
  • Fecha de publicación del evento
    2013-08-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-06-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120128
  • 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
    Tube, feeding - Product Code FPD
  • Causa
    Nestle healthcare nutrition, inc. is initiating a recall on some of compat ng tubes because they have been delivered in an insufficiently sealed pouch, thus compromising the sterility claimed on the label.
  • Acción
    Nestle Health Science sent a "Medical Device Recall" letter dated July 24, 2013. The letter was addressed to Risk Manger. The letter described the product involved, problem and actions to be taken. Customers were advised that products currently in use should not be returned. Customers were requested to examine their inventory, quarantine the product, carry the recall to the user facility level and to complete and return the Acknowledgment / Response Form. For questions call Nestle HealthCare Nutrition Customer Service at 1-877-463-7853.

Device

Device Recall Compat Nasogastric Feeding Tube
  • Modelo / Serial
    REF 08310400 - Compat¿ Nasogastric Feeding Tube 8 French (8Fr) in the following lots: 01413G  02412K 08211Z 08712W 14212U 14611P 21512Y 35411H  REF 08310500- Compat¿ Nasogastric Feeding Tube 12 French (12Fr) in the following lots: 01211AV 01513N  04111D, 04111P, 04111V 05812F 05912F 06313N 21512G 23412BV 34712V 35411U  REF 08310600 - Compat¿ Nasogastric Feeding Tube 10 French (10Fr) in the following lots: 08111M 08712D 10211E 13712W 21512F 05312N
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution - including the states of: AK, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA.
  • Descripción del producto
    Nestle Nutrition, Compat, Enteral Feeding Tube, sterile, 8 French (REF 08310400), 10 French (REF 08310600), and 12 French (REF 08310500). || Product Usage: || The Compat Nasogastric Feeding Tube is indicated for the administration of nutrition, fluids and medications into the stomach r small bowel by the naso-enteric, route for patients who have an intact gastrointestinal tract but are physically unable to ingest enough nutrients orally to meet their current needs.
  • Manufacturer
    Nestle HealthCare Nutrition

Manufacturer

Nestle HealthCare Nutrition
  • Dirección del fabricante
    Nestle HealthCare Nutrition, 12500 Whitewater Dr, Minnetonka MN 55343-9420
  • Empresa matriz del fabricante (2017)
    Nestlé S.A.
  • Source
    USFDA