Events

Retiro De Equipo (Recall) de Device Recall FlexiSeal Fecal Management System Advanced Odor Control Kit

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 ConvaTec.

¿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
    50225
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0618-2009
  • Fecha de inicio del evento
    2008-11-20
  • Fecha de publicación del evento
    2008-12-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-03-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75003
  • 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
    Gastrointestinal Tubes and Accessories - Product Code KNT
  • Causa
    It was discovered that a portion of the inner nylon sleeve of the catheter was visible at the balloon end of a sample device.
  • Acción
    Urgent Product Correction Letters were sent by first class mail on November 18, 2008 to Healthcare Professionals and ConvaTec Reps. The reason for the recall was identified along with possible risk to patient. Healthcare professionals were asked to use sufficient lubricating jelly during the insertion process with special care given to those who have a tendency to bleed or are on anti-coagulant medication. Physician should be notified if rectal bleeding or abdominal symptoms develop. ConvaTec reps were asked to contact all health care professionals to whom product or samples were given and reinforce the importance of proper lubrication and following the directions. A return form is to be completed by ConvaTec reps for each visit indicating the name of the Health Care Provider and that the they personally received notice of the product correction. All remaining sample products are to be returned to Besta, Franklin, WI.

Device

Device Recall FlexiSeal Fecal Management System Advanced Odor Control Kit
  • Modelo / Serial
    Lot number 08-TM-51
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution --- including USA and country of Canada.
  • Descripción del producto
    Flexi-Seal Fecal Management System Advanced Odor Control Kit. || Rx only; 1 silicone catheter tube assembly, 3-1 Liter collection bags with filters, 1 luer-lock syringe, SKU #411104 || ConvaTec || Skillman, NJ || Made in USA with imported components || "For the fecal management of patients with little or no bowel control and liquid or semi-liquid stool."
  • Manufacturer
    ConvaTec

Manufacturer

ConvaTec
  • Dirección del fabricante
    ConvaTec, 200 Headquarters Park Dr, Skillman NJ 08558
  • Empresa matriz del fabricante (2017)
    Triona Holding Sa
  • Source
    USFDA