Events

Retiro De Equipo (Recall) de Device Recall EndoVive 3s Low Profile Balloon Kits

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 Xeridiem Mediem Medical Devices 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
    73024
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0955-2016
  • Fecha de inicio del evento
    2015-12-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-10-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142851
  • 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 with Enteral Specific Connectors - Product Code PIF
  • Causa
    A feeding (reflux) valve leakage issue. the feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the low profile balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
  • Acción
    Xeridiem sent a customer notification letter dated December 23, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customer was provided the following instructions: 1. Segregate all devices from the above table that in Boston Scientific Corporation's inventory and restrict them from being distributed to end users. 2. Determine the list of end users who have received devices from the above list, notify them of the quality issue, and have these devices returned to Boston Scientific Corporation. Provide Xeridiem Medical Devices with this list of end users. For any questions the customers is instructed to contact the firm. For questions regarding this recall call 520-882-7794.

Device

Device Recall EndoVive 3s Low Profile Balloon Kits
  • Modelo / Serial
    Part Number: M00548400 (XMD P/N 70-0050-714)  Lot Number: 928912
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution to MA only.
  • Descripción del producto
    EndoVive 3s Low Profile Balloon Kits || Part Number: || M00548400 || (XMD P/N 70-0050-714) || The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
  • Manufacturer
    Xeridiem Mediem Medical Devices Inc

Manufacturer

Xeridiem Mediem Medical Devices Inc
  • Dirección del fabricante
    Xeridiem Mediem Medical Devices Inc, 4700 S Overland Dr, Tucson AZ 85714-3430
  • Source
    USFDA