Events

Retiro De Equipo (Recall) de Convatec Inc.

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 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
    68292
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1785-2014
  • Fecha de inicio del evento
    2014-04-29
  • Fecha de publicación del evento
    2014-06-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-08-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127287
  • 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
    Tubes, gastrointestinal (and accessories) - Product Code KNT
  • Causa
    Convatec inc. is recalling flexi-seal fms control kit since it does not have a 510k. in addition, an internal assessment of product performance, including a review of customer feedback, has confirmed that flexi-seal control is not meeting expectations or those of customers. specifically, the auto-valve feature that is unique to the flexi-seal control has not been consistently performing relative.
  • Acción
    Convatec Inc. sent an Urgent Voluntary Medical Device Recall letter dated April 29, 2014 via UPS. The letter identified the affected product, problem and actions to be taken. Customers are asked to immediately stop distributing and quarantine all recalled lots. Affected products must be returned to Distributor. Contact your Distributor for shipping instruction. Customers should completed the attached return response form and return it to the address on the response form. Questions can be directed to Gregory Kowzun at (336) 547-3710. Convatec issued a press release on 7/3/2014.

Device

Convatec Inc.
  • Modelo / Serial
    13-FM-0301  13-FM-0302  13FM0303  13-FM-0303  13FM0309  13VM509948  13VM509949  13VM510046  13VM512473  13VM513636  13VM513642  13VM516733  13VM520039  13VM521731  13VM521733  13VM524363  13VM524364  13VM527149  13VM527150  13VM528992  13VM528994  13VM531214  14FM0301  14VM531935  14VM532098
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA Nationwide
  • Descripción del producto
    Convatec Flexi Seal Control Fecal Management System Rx Only || REF 411107 || Product Usage:For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications as prescribed by a physician.
  • Manufacturer
    Convatec Inc.

Manufacturer

Convatec Inc.
  • Dirección del fabricante
    Convatec Inc., 200 Headquarters Park Dr, Skillman NJ 08558-2600
  • Empresa matriz del fabricante (2017)
    Triona Holding Sa
  • Source
    USFDA